[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Cancer Institute (NCI)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":636},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,368,0,25,[9,44,67,100,123,144,169,198,226,254,284,306,326,347,374,396,420,441,466,490,516,538,560,582,615],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100054268","phase-2-testing-the-use-of-neratinib-or-the-combination-of-neratinib-and-palbociclib-targeted-treatment-for-her2-solid-tumors-a-combomatch-treatment-trial-100054268",false,"NCT06126276","Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)","A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination With Palbociclib, a CDK4\u002F6 Inhibitor, in Patients With HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial","Inclusion Criteria:\n\n* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191\n* Patients must have a HER2 amplified solid tumor except breast cancer.\n\n  * If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)\u002FFISH or next generation sequencing (NGS) status\n  * If IHC is 3+, pt IS ELIGIBLE regardless of ISH\u002FFISH or NGS status\n  * If IHC is 2+, ISH\u002FFISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE\n  * If IHC is unknown and…\n\n    * ISH\u002FFISH is positive, independent of NGS results, the patient IS ELIGIBLE\n    * ISH\u002FFISH is negative and NGS positive with ≥ 7 copies, the patient IS ELIGIBLE\n* Patients must have recurrent or persistent disease\n* No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation\n* Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)\n* Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required\n* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic\n* No known leptomeningeal disease\n* Patients may have received up to 5 prior lines of systemic therapy\n* Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed\n* No prior therapy with HER2 targeting tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib\n* No prior therapy with CDK4\u002F6 inhibition\n* No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2\n* Not pregnant and not nursing\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 9 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g\u002Fdl is acceptable)\n* Creatinine clearance (CrCL) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN)\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No active infection requiring parenteral antibiotics\n* No current evidence of intra-abdominal abscess, abdominal\u002Fpelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and\u002For need for drainage nasogastric or gastrostomy tube\n* No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy\n* No lung disease causing dyspnea at rest\n* No interstitial lung disease with ongoing signs and symptoms at the time of registration\n* No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients","ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.",[27,28,29,30],"Malignant Female Reproductive System Neoplasm","Malignant Solid Neoplasm","Recurrent Malignant Female Reproductive System Neoplasm","Recurrent Malignant Solid Neoplasm","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2024-05-07",{"date":39,"type":21},"2027-02-20",{"name":41,"class":42},"National Cancer Institute (NCI)","NIH",188,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100054227","phase-3-testing-the-addition-of-an-antiangiogenic-drug-bevacizumab-to-chemotherapy-carboplatin-and-paclitaxel-combined-with-immunotherapy-pembrolizumab-for-pmmr-tp53-mutated-endometrial-cancer-100054227","NCT07198074","Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer","A Randomized Phase III Trial of Carboplatin, Paclitaxel, Pembrolizumab Versus Carboplatin, Paclitaxel, Bevacizumab Versus Carboplatin, Paclitaxel, Pembrolizumab, Bevacizumab in the Treatment of pMMR, TP53 Mutated Advanced or Recurrent Endometrial Cancer","Inclusion Criteria:\n\n* Documentation of disease:\n\n  * Stage III and stage IVA endometrial cancers (with measurable disease),\n  * Stage IVB endometrial cancer (with or without measurable disease), or\n  * Recurrent endometrial cancer (with or without measurable disease)\n* In patients with measurable disease, lesions will be defined and monitored by RECIST 1.1. Measurable disease (RECIST 1.1) is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT or MRI. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI\n* Histologic confirmation of the original primary tumor is required (submission of pathology report\\[s\\] is required). Patients with the following histologic types are eligible: endometrioid, serous, dedifferentiated\u002Fundifferentiated, clear cell, mixed epithelial, carcinosarcoma, adenocarcinoma not otherwise specified (N.O.S.)\n* Patients must have:\n\n  * Tumoral mismatch repair proficient (pMMR) disease as assessed by immunohistochemistry (IHC) AND\n  * P53 IHC with aberrant staining pattern (aberrant p53 expression is consistent with mutant TP53). TP53 mutation by next-generation sequencing will also be accepted\n* A pathology report demonstrating results of institutional MMR IHC and p53 IHC and\u002For TP53 by next-generation sequencing\n* Patients may have received:\n\n  * NO prior chemotherapy for treatment of endometrial cancer OR\n  * Prior adjuvant chemotherapy (e.g., paclitaxel\u002Fcarboplatin alone or as a component of concurrent chemotherapy and radiation therapy \\[with or without cisplatin\\]) provided adjuvant chemotherapy was completed ≥ 12 months prior to registration\n* Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic\u002Fpara-aortic radiation therapy, intravaginal brachytherapy, and\u002For palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration. For patients with recent radiation, they must have RECIST-evaluable disease outside of the radiation field and have recovered their marrow function\n* Patients may have received prior hormonal (endocrine) therapy. All hormonal (endocrine) therapy must have been completed at least 1 week prior to registration\n* NO prior pembrolizumab (or other anti-PD1, anti-PDL1 or anti-CTLA4 therapy) or bevacizumab (or other antiangiogenic therapy)\n* Interval or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of disease progression. Patients with brain metastases must have follow up imaging demonstrating no evidence of disease progression and that the disease is stable off of steroids\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Not pregnant and not nursing\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 8 g\u002Fdl\n* Creatinine clearance (CrCl) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* No active infection requiring parenteral antibiotics\n* No current evidence of intra-abdominal abscess, abdominal\u002Fpelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and\u002For need for drainage nasogastric or gastrostomy tube\n* No clinically significant bleeding within 28 days prior to registration\n* No uncontrolled hypertension, defined as systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg\n* No major surgery within 28 days of initiation of bevacizumab\n* No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease\n\n  * Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible\n  * Topical or inhaled steroids are allowed\n  * Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), and anti-thyroid antibodies should be evaluated with the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\n* No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis\n* No history of stem cell or solid organ transplant\n* No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)","FEMALE",{"count":53,"type":21},255,[55],"PHASE3","This phase III trial compares the effect of bevacizumab in combination with carboplatin, paclitaxel and pembrolizumab to the usual treatments of carboplatin and paclitaxel with or without pembrolizumab in treating patients with stage III, IVA or IVB mismatch repair protein proficient (pMMR) and TP53 mutated endometrial cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adding bevacizumab to the combination of carboplatin, paclitaxel and pembrolizumab may be more effective than the usual treatment combinations of carboplatin and paclitaxel with or without pembrolizumab in treating patients with advanced or recurrent pMMR and TP53 mutated endometrial cancer.",[58,59],"Advanced Endometrial Carcinoma","Recurrent Endometrial Carcinoma",{"date":34,"type":35},{"date":62,"type":35},"2026-01-27",{"date":64,"type":21},"2028-07-01",{"name":41,"class":42},232,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100054185","phase-1-pacritinib-a-kinase-inhibitor-of-csf1r-irak1-jak2-and-flt3-in-adults-and-pediatric-participants-12-years-of-age-or-older-with-myelodysplastic-syndromes-or-myelodysplasticmyeloproliferative-neoplasms-100054185","NCT06303193","Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic\u002FMyeloproliferative Neoplasms","Phase I\u002FII Trial of Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic\u002FMyeloproliferative Neoplasms","* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed MDS or MDS\u002FMPN, including therapy-related MDS or MDS\u002FMPN, and MDS or MDS\u002FMPN with germline predisposition, by the Department of Laboratory Medicine Hematology Laboratory, CC or by the Laboratory of Pathology, NCI as defined according to the 2016 WHO criteria, 2022 WHO criteria, or 2022 International Consensus Classification\n* Age 12-17 years for phase I and age \\>= 18 years for phase II\n* Participants \\>= 18 years of age with HR-MDS must have resistance to hypomethylating agents as defined as failure to show improvement after at least 4 cycles of treatment (primary resistance) or relapse in participants with initial response to long-term treatment (secondary resistance) OR have intolerance to hypomethylating agents OR have a contraindication to hypomethylating agents\n* Participants \\>= 18 years of age with LR-MDS must be refractory to or ineligible to receive standard of care therapies, i.e. erythropoietin-stimulating agents, lenalidomide, luspatercept, and present with one of the following characteristics:\n\n  * Severe neutropenia defined by absolute neutrophils count \\\u003C=0.5(SqrRoot) 10\\^9\u002FL without the use of granulocyte colony-stimulating factors\n  * Symptomatic anemia defined by hemoglobin 16-week average \\\u003C10 g\u002FdL and symptoms that may include fatigue, weakness, reduced exercise tolerance, dyspnea on exertion, palpitations, (orthostatic) hypotension, near syncope and restless legs\n  * Thrombocytopenia defined as platelets \\\u003C20(SqrRoot) 10\\^9\u002FL or platelets \\\u003C50(SqrRoot) 10\\^9\u002FL and a history of clinically relevant non-major or major bleeding according to the ISTH classification\n* Participants 12-17 years of age with MDS must be relapsed\u002Frefractory OR ineligible to receive immunosuppressive therapy and hematopoietic stem cell transplantation\n\n  --Ineligibility to receive hematopoietic stem cell transplantation will include participants who are not anticipated to be candidates to receive transplantation within the next 3 months due to medical comorbidities, lack of appropriate donor, or logistical barriers to transplant\n* Participants with MDS\u002FMPN must be relapsed\u002Frefractory (failed a minimum of 1 standard of care therapy) OR ineligible to receive standard of care OR without known life-prolonging therapy options OR have a diagnosis for which no known standard of care exists\n* Participants 12-17 years of age must weigh \\>= 35 kg\n* If any of the prior therapies noted below were given to the participant, they must have been completed within the following timeframes:\n\n  * 7 days from last dose of short-acting myeloid growth factors (i.e., filgrastim) and \\>= 14 days for long-acting (i.e., pegfilgrastim)\n  * 14 days from last dose of short-acting thrombopoietic growth factors (i.e.,eltrombopag) and \\>= 28 days for long-acting (i.e., romiplostim)\n  * 14 days or 5 pharmacokinetic half-lives from biological therapy agent\n  * 21 days from myelosuppressive chemotherapy\n  * 28 days from last dose of immunosuppressive therapy (e.g., ATG, cyclosporine, steroids greater than physiologic replacement)\n  * 28 days from last dose of lenalidomide\n  * 28 days from last dose of venetoclax\n  * 28 days from any other investigational agent\n  * 42 days from last dose of erythropoiesis stimulating agents\n  * 56 days from last dose of luspatercept\n  * 100 days from stem cell transplant with no evidence of active graft vs. host disease in participants who relapsed following transplant\n  * 150 days from total body irradiation\n* Performance status:\n\n  * For participants \\>= 16 years of age, ECOG performance status \\\u003C 2 (Karnofsky \\>= 60%)\n  * For participants \\\u003C 16 years of age, Lansky \\>= 60%\n* Participants must have adequate organ function as defined below:\n\n  * Total bilirubin: \\\u003C= 1.5 X institutional upper limit of normal OR \\\u003C= 3 x institutional upper limit of normal in participants with Gilbert s syndrome\n  * AST(SGOT)\u002FALT(SGPT): \\\u003C= 2.5 X institutional upper limit of normal\n  * Creatinine clearance: \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal\n  * PT and PTT: \\\u003C= 1.5 X institutional upper limit of normal, except in the setting of PTT elevation due to lupus anticoagulant, in which case these participants would be exempt from meeting this inclusion criterion\n* Individuals of child-bearing potential (IOCBP) and individuals able to father a child with a partner able to become pregnant must agree to use one (1) highly effective form of contraception (e.g., intrauterine device \\[IUD\\], surgical) or two (2) effective forms of contraception (e.g., barrier method) while on study drug and for 30 days after the last dose of study drug\n* Nursing participants must discontinue breastfeeding and\u002For not begin breastfeeding until 2 weeks after the last dose of study drug\n* Ability of participant or parent\u002Fguardian (for participants 12-17 only) to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\n* Participants with platelet transfusion-refractory thrombocytopenia, with inability to keep platelet threshold above 10 K\u002FmcL with transfusions\n* Participants with evidence of ongoing hemorrhage, active signs\u002Fsymptoms of bleeding, or history of severe (grade \\>= 3) unprovoked bleeding complications in the one year prior to enrollment, or any unprovoked grade 2 bleeding complications in the 3 months prior\n\nto enrollment\n\n* Use of anti-platelet or anticoagulant medication other than low-dose aspirin (100 mg daily or less) in the 14 days prior to enrollment, or any ongoing requirement for these medications\n* Participants who are unwilling to accept blood transfusions\n* Participants with ANC \\\u003C 500 cells\u002FmcL AND hospitalization for a fungal infection in the 12 months prior to enrollment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pacritinib\n* Concomitant administration with sensitive substrates\u002Fnarrow therapeutic index drugs of CYP3A4, CYP1A2, P-gp BCRP, and OCT1 should be avoided. Concurrent use of strong inhibitors and inducers of CYP3A4 are not allowed. Prior use is allowed as long as medication is stopped two weeks prior to study drug initiation. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.\n* Concomitant administration of medications with significant potential to cause QTc prolongation.\n* Participants with the following cardiac conditions at screening:\n\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Uncontrolled cardiac dysrhythmias\n  * QTc(F) prolongation \\>450 ms, or other factors that increase the risk for QT prolongation (i.e., heart failure, or a history of long QT interval syndrome)\n* Grade \\>= 3 cardiac complication in the 6 months prior to enrollment\n* Left ventricular ejection fraction \\\u003C= 50% by transthoracic echocardiogram (TTE) at screening\n* Participants with any active, uncontrolled viral, bacterial, or fungal infection, including active HIV-1, Hepatitis B (HBV) and\u002For Hepatitis C (HCV) infection (positive HBV or HCV viral load in the setting of positive HBV core antibody or surface antibody or HCV antibody); history of HIV, HBV, or HCV is allowed if there is no uncontrolled viral infection\n* Pregnancy\n* Presence of another known cause of cytopenia or dysplastic marrow that is untreated and may limit interpretation of results\n* Uncontrolled intercurrent illness or any significant disease, evaluated by history, physical exam and chemistries or social situations that may limit interpretation of results, limit compliance with study requirements, or that could increase risk to the participant","12 Years","120 Years",{"count":77,"type":21},160,[79,24],"PHASE1","Background:\n\nMyelodysplastic syndrome (MDS) and myelodysplastic\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) are blood disorders that can cause serious complications in children and adults. MDS and MDS\u002FMPN can also progress to acute myeloid leukemia. Treatments for these disorders are risky and not always effective. Better treatments are needed.\n\nObjective:\n\nTo test a study drug (pacritinib) in adults and children with MDS or MDS\u002FMPN.\n\nEligibility:\n\nChildren (aged 12 to 17 years) and adults (aged 18 years and older) with MDS or MDS\u002FMPN.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have tests of their heart function. They may have a bone marrow biopsy: An area over the hip will be numbed; a needle will be inserted to remove a sample of soft tissue from inside the hipbone.\n\nPacritinib is a capsule taken by mouth. All participants will take the study drug 2 times a day, every day, in 28-day cycles. They will write down the date and time they take each capsule. Doctors will assign varying dosages of the drug to different participants.\n\nParticipants will have clinic visits each week during cycle 1; every 2 weeks during cycle 2; and gradually increasing to every 3 months after cycle 13. Treatment will continue for up to 8 years.\n\nBone marrow biopsies, heart tests, and other tests will be repeated at intervals throughout the study. Participants will also fill out questionnaires about their quality of life, the symptoms of their disease, and other topics.",[82],"Myelodysplastic Syndromes",[84,85,86,87,88,89,90,91,92],"Myelodysplastic Syndrome","bone marrow disorder","Myelodysplasia","myeloproliferative disorders","pediatric bone marrow failure","5q deletion","multi-lineage dysplasia","Clonal Hematopoiesis","Aplastic Anemia",{"date":34,"type":35},{"date":95,"type":21},"2026-07-16",{"date":97,"type":21},"2035-01-01",{"name":41,"class":42},1,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100053397","phase-2-testing-the-addition-of-cemiplimab-regn2810-to-chemotherapy-treatment-given-prior-to-surgery-in-patients-with-sinonasal-squamous-cell-carcinoma-100053397","NCT07281417","Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma","Neoadjuvant Chemotherapy With or Without Cemiplimab (REGN2810) in Sinonasal Squamous Cell Carcinoma: A Randomized Phase 2 Study","Inclusion Criteria:\n\n* Patients must have histologically confirmed squamous cell carcinoma of sinonasal origin\n* Patients must have a T stage (T3, T4a, and select T4b) primary tumor according to American Joint Committee on Cancer (AJCC) 8th edition. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam\n* No evidence of metastatic disease determined by pre-treatment imaging. Metastatic disease to neck nodes is considered locally advanced and therefore allowable. Patients with N0 and N1-3 disease will be eligible\n* Known HPV status (i.e., HPV negative, p16 immunohistochemistry \\[IHC\\] positive, high risk \\[HR\\]-HPV in situ hybridization \\[ISH\\] positive) from testing performed prior to referral. HPV status data (e.g., date of test, type of test \\[p16 IHC or HR-HPV ISH\\] and testing result) must be collected during enrollment. Patients who do not have this information available for collection will not be enrolled on this study\n* Age ≥ 18 years\n\n  * Because no dosing or adverse event data are currently available on the use of cemiplimab (REGN2810) in combination with carboplatin and paclitaxel in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Hemoglobin ≥ 8 g\u002FdL (acceptable to reach via transfusion)\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Creatinine clearance ≥ 40 mL\u002Fmin\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Based on its mechanism of action, cemiplimab (REGN2810) can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1\u002FPD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. For this reason and because paclitaxel is a class D agent with the potential for teratogenic or abortifacient effects, women of childbearing potential (WCBP) and men should use highly effective contraception during treatment and for 6 months after the last dose of the study drugs. WCBP and men should avoid donating eggs\u002Fsperm during treatment and for 6 months after the last dose of the study drugs. Women should discontinue nursing during treatment and for 6 months after the last dose of the study drugs\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Prior to enrollment, verification of payment coverage by insurance (or other payment) for neoadjuvant paclitaxel and carboplatin chemotherapy must be obtained\n\nExclusion Criteria:\n\n* Patients with unresectable disease\n* Patients presenting with T3 disease without the need for maxillectomy and\u002For orbital invasion requiring orbital dissection\u002Fresection\n* Patients who have had any previous systemic therapy to the index lesion in the past 12 months. This includes cemiplimab (REGN2810) and\u002For other immune modulating agents. Previous systemic therapy may alter or affect response\n* Patients who had palliative RT (\\\u003C 20 Gy) within 1 week prior to entering the study\n* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)\n* History of pneumonitis within the last 5 years\n* Patients who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cemiplimab (REGN2810) or carboplatin and paclitaxel\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because of the increased risk of immune-mediated rejection of the developing fetus with cemiplimab (REGN2810). Men and WCBP who are not prepared to use highly effective contraception during and for 6 months after completion of treatment are excluded from this study",{"count":108,"type":21},108,[24],"This phase II trial compares the effect of chemotherapy (carboplatin and paclitaxel) with versus without cemiplimab given before surgery (neoadjuvant) in patients with sinonasal squamous cell cancer. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients with sinonasal squamous cell cancer is surgery followed by radiation therapy, with or without chemotherapy. Recently, some patients have also been treated with neoadjuvant chemotherapy before surgery. Adding cemiplimab to chemotherapy before surgery may be more effective at stopping the cancer from growing or spreading, compared to chemotherapy alone.",[112,113,114,115],"Sinonasal Squamous Cell Carcinoma","Stage III Sinonasal Cancer AJCC v8","Stage IVA Sinonasal Cancer AJCC v8","Stage IVB Sinonasal Cancer AJCC v8",{"date":34,"type":35},{"date":118,"type":21},"2026-11-24",{"date":120,"type":21},"2030-12-16",{"name":41,"class":42},5,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100054084","phase-2-testing-the-anti-cancer-drug-glofitamab-in-patients-with-mantle-cell-lymphoma-a-type-of-blood-cancer-whose-disease-returned-after-car-t-cell-therapy-100054084","NCT07003295","Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy","A Phase II Study of Glofitamab for Relapsed\u002FRefractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed diagnosis of mantle cell lymphoma that is relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen)\n* Patients must have been previously treated with an anti-CD19 CAR T-cell therapy and have failed or been intolerant to Bruton's tyrosine kinase (BTK) inhibition. Both commercial and investigational CAR-T products which target CD19 will be allowed, including dual-targeting products\n* Patients must have at least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of glofitamab and obinutuzumab in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 50,000\u002FmcL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x institutional ULN if the patient has Gilbert syndrome\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Creatinine ≤ 1.5 x institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n* Patients with human immunodeficiency virus (HIV) infection are eligible if on effective anti-retroviral therapy with undetectable viral load within 6 months\n* Patients with a history of hepatitis B virus (HBV) infection or positive total hepatitis B core antibody (HBcAb) are eligible if the hepatitis B surface antigen (HBsAg) is negative and HBV DNA viral load is undetectable by polymerase chain reaction (PCR) at the time of screening. Such patients must be managed with appropriate anti-viral therapy, if indicated, and must be willing to undergo HBV DNA testing on day 1 of each cycle and every 3 months for at least 12 months after the final cycle of study treatment\n* Patients with a history of hepatitis C virus (HCV) infection or positive HCV antibody are eligible if HCV ribonucleic acid (RNA) viral load is undetectable by PCR\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and patients are asymptomatic from CNS involvement\n* Patients with new, progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that patients are asymptomatic and immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, such as patients with prostate cancer or breast cancer receiving hormonal therapy\n* The effects of glofitamab and obinutuzumab on the developing human fetus are unknown. For this reason and because glofitamab and obinutuzumab are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 months after completion of glofitamab and 6 months after completion of obinutuzumab administration. Women of childbearing potential must use effective contraceptive precautions 2 months after completion of glofitamab treatment and 18 months after the last dose of obinutuzumab treatment\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to glofitamab and obinutuzumab\n* Pregnant women are excluded from this study because glofitamab and obinutuzumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with glofitamab and obinutuzumab, breastfeeding should be discontinued if the mother is treated with glofitamab and obinutuzumab\n* Patients with active CRS or requiring intervention for CRS within 14 days prior to study enrollment\n* Patients with active neurotoxicity or requiring intervention for neurotoxicity within 14 days prior to study enrollment\n* Patients requiring antimicrobial treatment or hospitalization for active infection within 14 days prior to study enrollment for known active bacterial, viral (including severe acute respiratory syndrome coronavirus 2 \\[SARS-CoV-2\\]), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds). Infection must be completely resolved prior to initiation of study treatment\n* Patients receiving systemic immunosuppressive medications within 14 days prior to study enrollment, including, but not limited to: prednisone ≥ 20 mg per day, azathioprine, methotrexate, anti-tumor necrosis factor agents, anti-interleukin-6\u002F6R agents, or anti-interleukin 1 agents, are not eligible. The use of inhaled corticosteroids is permitted\n* Patients with known or suspected chronic active Epstein Barr virus (EBV) or cytomegalovirus (CMV) infection\n* Patients with known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Patients with prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n* Patients with known history of progressive multifocal leukoencephalopathy\n* Patients with current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed\n* Patients with the significant cardiovascular disease, including New York Heart Association class III or IV or otherwise symptomatic heart failure (stage C or D), myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina\n* Patients who have undergone major surgery for non-diagnostic purposes within 4 weeks before first study treatment\n* Patients who have received a live attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study\n* Patients with a positive SARS-CoV-2 test 7 days prior to enrollment\n* Patients with current or past history of Waldenström macroglobulinemia\n* Patients with an active autoimmune disease that could be exacerbated by immunotherapy, excluding those with a remote history or well-controlled autoimmune disease",{"count":131,"type":21},20,[24],"This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving glofitamab and obinutuzumab may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.",[135,136],"Recurrent Mantle Cell Lymphoma","Refractory Mantle Cell Lymphoma",{"date":34,"type":35},{"date":139,"type":35},"2026-07-08",{"date":141,"type":21},"2027-08-31",{"name":41,"class":42},9,{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":99},"100053467","phase-1-phase-iii-study-of-the-combination-immunotherapy-regimen-sx-682-triadeno-vaccine-retifanlimab-and-il-15-agonist-n-803-star15-for-metastatic-colorectal-cancer-mcrc-100053467","NCT06149481","Phase I\u002FII Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)","* INCLUSION CRITERIA:\n* Participants with histologically confirmed colorectal cancer and evidence of metastatic disease.\n* Participants must have received, been ineligible to receive, or refused to receive two lines of standard systemic therapy i.e., a fluoropyrimidine with oxaliplatin or irinotecan with bevacizumab, regorafenib, trifluridine, and (if history of RAS wild-type) EGFR-targeted therapy. Participants must have received one line of systemic checkpoint inhibitor if history of advanced microsatellite instability-high \\[MSI-H\u002FdMMR\\]) metastatic colon cancer.\n* Participants who had progressive disease within 6 months before study treatment following standard adjuvant therapy are eligible if they have not received systemic therapy for metastatic disease. Participants with a history of MSI-H\u002FdMMR must have also received one line of checkpoint inhibitor therapy.\n* Age \\>= 18 years.\n* Measurable disease per RECIST 1.1.\n* ECOG performance status \\\u003C= 2.\n* Adequate organ and marrow as a function defined below:\n\n  * absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3\n  * platelet count \\>= 100,000 cells\u002Fmm\\^3\n  * hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * total bilirubin level \\\u003C 1.5 x upper limit of normal (ULN)\n  * alanine aminotransferase (ALT) \\\u003C= 2.5 x ULN OR \\\u003C= 5 x ULN for participants with liver metastases\n  * aspartate aminotransferase (AST) level \\\u003C= 2.5 x ULN OR \\\u003C= 5 x ULN for participants with liver metastases\n  * creatinine clearance (CrCl) calculated by Cockroft-Gault formula \\>= 50 mL\u002Fmin\n* Resolution of toxic effect(s) of prior anti-cancer therapy (except alopecia and neuropathy) to Grade \\\u003C=1 or to \\\u003C=2 if effective medical management of those toxicities is in place such that they are controlled per standard of care (e.g., grade 2 hypothyroidism requiring oral thyroid replacement).\n* Participants with treated brain metastases are eligible if clinically appropriate follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* Participants positive for human immunodeficiency virus (HIV) are eligible if they are compliant with appropriate anti-retroviral therapy for at least 6 months, have HIV viral load \\\u003C400 copies\u002FmL, and a CD4 count \\> 350 cells\u002Fmicroliter at screening.\n* Participants positive for Hepatitis C virus (HCV) are eligible if they have completed definitive anti-viral therapy and have an undetectable viral load.\n* Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization) at study entry and up to 6 months after the last dose of the study drug(s).\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after study treatment discontinuation.\n* Participants must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies in the phase 1 portion of the study. Lesions to be biopsied will be determined safely accessible by the provider performing the biopsy (e.g. interventional radiology if a liver or lung biopsy) prior to performing the biopsy. Note: If Phase 2 opens, per the investigator s discretion, if biopsy is strenuous to obtain, e.g., no easily accessible lesions are available or the subject\n\ncondition is not amenable for biopsy, then the subject will be eligible for enrollment without biopsy at screening and for continuation of treatment without on-treatment study biopsy.\n\n-Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with prior investigational drug, chemotherapy, immunotherapy, or any prior therapeutic radiotherapy within 14 days prior to study treatment initiation.\n* Participants with palliative radiotherapy performed within 7 days prior to study treatment initiation.\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent) with the exception of:\n\n  * intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections in participants with asthma\n  * using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption\n  * brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy).\n* Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis. Participants with chronic post-radiation pulmonary changes\u002Fscarring that is asymptomatic are eligible.\n* Active infections requiring systemic antibiotics or antifungal or antiviral treatment within 8 days prior to treatment initiation. Participants who have had appropriate antibiotics initiated but are still completing the treatment course are eligible if clinically improved or had minimal symptoms at presentation (e.g., urinary tract infection or pharyngeal streptococcal infection without evidence of systemic inflammatory response).\n\n  * History of organ transplant, including allogeneic stem cell transplantation.\n  * Participants who experienced immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy was recommended (per product label or consensus guidelines) or any immune-related toxicity requiring systemic corticosteroids (with the exception of endocrinopathy that is well controlled on replacement hormones).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.\n* Receipt of a live vaccine within 28 days prior to treatment initiation. Note: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.\n* History of infection with Hepatitis B virus (HBV) unless on suppressive therapy. Individuals with serologic evidence of a resolved prior HBV infection (i.e., HBsAgnegative and anti-HBc positive) are eligible.\n* Pregnancy confirmed with Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.",{"count":151,"type":21},60,[79,24],"Background:\n\nEach year, more than 32,000 people in the United States are diagnosed with colorectal cancer that has returned or progressed after treatment and spread to other organs. This is called metastatic colorectal cancer (mCRC). Most people with mCRC survive only about 2 years.\n\nObjective:\n\nTo test the ability of a combination of up to 4 experimental anti-cancer drugs treat mCRC. The names of these drugs are retifanlimab, TriAdeno vaccine, N-803, and SX-682. They are described below.\n\nEligibility:\n\nAdults aged 18 years or older with mCRC. Participants must have\n\nDesign:\n\nParticipants will be screened. This includes having a physical exam, blood tests, urine tests, and imaging tests. If signed on to the study, participants will have 2 tumor biopsies. One when starting the study and once about 8 weeks after bring on the study. Participants will receive $500 for each biopsy.\n\nParticipants will be treated with either 3 or 4 drugs and will receive a detailed calendar explaining when each drug is given.\n\nRetifanlimab is given every 4 weeks through an IV (an IV is tube attached to a needle inserted into a vein in the arm). N-803 is injected under the skin on the abdomen every 4 weeks.\n\nTriAdeno vaccine is injected under the skin of the upper arm or thigh once a month for 3 doses and then once every 3 months.\n\nSome participants will also receive a 4th drug. SX-682 is a pill taken by mouth. Participants will take this drug 2 times a day at home for about 3 weeks of each month.\n\nStudy treatment will continue up to 2 years. Follow-up phone calls\u002Femails may continue for 3 more years.",[155],"Metastatic Colorectal Cancer",[157,158,159,160,161,162],"Monoclonal Antibody","Brachyury","MUC-1","Immunoglobulin G cytokine fusion protein","chemokine antagonist","Small Molecule",{"date":34,"type":35},{"date":165,"type":35},"2024-03-26",{"date":167,"type":21},"2030-10-31",{"name":41,"class":42},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":17,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":187,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":195,"leadSponsor":197,"locationsCount":99},"100053437","phase-2-stem-cell-transplantation-for-participants-with-germline-runx1-associated-blood-cancers-100053437","NCT07524530","Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers","Phase II Haploidentical Hematopoietic Stem Cell Transplantation for Participants With Germline RUNX1 Associated Hematologic Malignancies","* INCLUSION CRITERIA:\n* Affected participants (Recipients)\n\n  * History of deleterious or suspected deleterious (defined as P\u002FLP or VUS with RUNX1 phenotype) germline RUNX1 mutation as defined by ClinVar (nih.gov)\n  * Histological confirmation of a myeloid malignancy - acute or chronic leukemia (\\\u003C5% marrow blasts preferred) or myelodysplastic syndrome\u002Fmyeloproliferative neoplasms (MDS\u002FMPN) (\\\u003C10% marrow blasts preferred). Participants may be treated on this study to achieve preferred blast cutoffs. Participants with poorly responsive or relapsed disease remain eligible and may proceed as the graft-versus-leukemia (GVL) effect may produce cures.\n\nSubjects requiring standard therapies to prepare for HCT should ideally be referred to this study in remission, if possible. However, sometimes disease status changes during evaluation for HCT and it is necessary to establish disease control through the administration of standard therapies during evaluation for HCT. If ongoing therapy for the underlying disease outside of the NIH is not in the best interest of the subject according to the clinical judgment of the NIH PI, then the subject may receive standard treatment for his\u002Fher underlying hematologic malignancy as a bridge to HCT on this protocol, prior to starting the research phase of the study. If it becomes apparent that the subject will not be able to proceed to HCT, then he\u002Fshe must come off study. Subjects receiving standard therapy will be told about the therapy, associated risks, potential benefits, alternatives to the proposed therapy, and the availability of receiving the same treatment elsewhere, outside of a research protocol.\n\n* Availability of a haploidentical donor (HLA-match only).\n* Age \\>= 4 and \\\u003C= 70 years\n* Karnofsky (\\>=16 years) or Lansky (\\\u003C16 years) \\>=60%\n* For human immunodeficiency virus (HIV)-infected participants, participant must be on effective anti-retroviral therapy, without uncontrolled opportunistic infection and have approval via Transplant Infectious Disease consultation. Consider donor with CCR5(delta)32 homozygosity for these participants.\n* For individuals with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load (VL) must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV VL.\n* Contraception as follows:\n\n  ---Women of child-bearing potential (WOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) at the study entry and up to and 12 months post conditioning and\u002For post-transplant.\n* Men that can father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 12 months posttransplant or 4 months after conditioning if transplant is not done. We also will recommend men that can father children with partners that can bear children ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Men that can father children must not freeze or donate sperm within the same period.\n* Breastfeeding participants must be willing to discontinue breastfeeding during the study and for 12 months post-transplant or 1 week after conditioning if transplant is not done.\n* Willingness to remain in the NIH hospital or, if discharged, stay close to the NIH (30 minutes drive), for a minimum of 100 days after transplant or longer if there are complications. The participants must commit to having an adult caregiver with them during the first 100 days after the transplant\n* Participants or parent\u002Fguardian\u002Flegally authorized representative must be able to understand and willing to sign a written informed consent document.\n* Additional criteria for recipients suitable for MAC\n\n  * Age \\\u003C= 65 years\n  * HCT-CI \\\u003C4\n  * Pulmonary function tests (PFTs): Forced expiratory volume in the first second (FEV1) and adjusted diffusion capacity of carbon monoxide (DLCO) \\>=66%, without dyspnea at rest or oxygen requirement. If too young to cooperate with PFTs, must have \\>=92% oxygen saturation on room air and no dyspnea at rest.\n  * Left ventricular ejection fraction (LVEF) \\>=50% by echocardiogram (ECHO) or Multigated Acquisition (MUGA) scan (101)\n  * Recipients must have adequate organ function as defined below:\n\n    * Total bilirubin \\\u003C1.5 x institutional upper limit of normal (iULN) (unless Gilbert disease, hemolysis)\n    * Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) \\\u003C=2.5 x iULN (unless therapy related and will improve in discussion with the National Institute of Diabetes and Digestive and Kidney Diseases \\[NIDDK\\])\n    * Creatinine within normal institutional limits or 24-hour urine or calculated creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for individuals with creatinine levels above institutional normal (calculated using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n* Additional criteria for recipients suitable for RIC\n\n  * Age \\\u003C=70 years\n  * PFTs: FEV1 and DLCO \\>=50%, without dyspnea at rest or oxygen requirement. If too young to cooperate with PFTs, must have \\>=92% oxygen saturation on room air and no dyspnea at rest\n  * LVEF \\>=40% by ECHO or MUGA obtained within 2 months of HSCT (Children s Oncology Group \\[COG\\] criteria).\n  * Recipients must have adequate organ function as defined below:\n\n    * Total bilirubin \\\u003C2.5 x iULN (unless Gilbert disease, hemolysis)\n    * AST\u002FALT \\\u003C3.5 x iULN (unless therapy related and will improve in discussion with NIDDK)\n    * Creatinine within normal institutional limits or 24-hour urine or calculated creatinine clearance \\>=50 mL\u002Fmin\u002F1.73 m\\^2 for individuals with creatinine levels above institutional normal (calculated using the CKD-EPI equation)\n* Unaffected participants\n\n  * Haploidentical donors\n\n    ----Age \\>=4 years\n  * Participants or parent\u002Fguardian must be able to understand and willing to sign a written informed consent document.\n  * Unaffected family members\n\n    * Age \\>=18 years\n    * If the participant is a blood relative of the recipient, participant must be negative for RUNX1 mutations by molecular testing\n    * Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n-All participants\n\n* Recipients who are receiving any investigational agent except virus specific T cells (VST)\n* Active non-hematologic malignancies\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in study.\n* Participants with the following cardiac conditions: symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (except atrial fibrillation if cleared by cardiology consultation)\n* Participants without access to medical care at home.\n* Positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test at screening\n* Uncontrolled intercurrent illness evaluated by history, physical exam, and laboratory studies or situations that would limit compliance with study requirements, interpretation of results or that could increase risk to the participant","4 Years","70 Years",{"count":179,"type":21},98,[24],"Background:\n\nSome blood cancers can be caused by germline variants (changes) in a person s RUNX1 gene. Germline variants are genetic inherited changes a person is born with. Stem cell transplants are used to treat many diseases including blood cancers. Stem cell transplantation for patients with germline RUNX1 mutation driven blood cancers is standard of care and available in most major medical centers. The difference with this transplantation protocol is that it is prospective, only available to participants with germline RUNX1 variants and designed to determine the extent to which tailoring chemotherapy and supportive care medication doses for each individual patient may improve outcomes compared to data derived from retrospective transplantation protocols for patients with RUNX1 varinats which is less accurate.\n\nObjective:\n\nThe primary objective of this protocol is to determine how tailored doses of chemotherapy and supportive care medications may improve disease free survival as compared to historical\u002Fexpected disease free survival.\n\nEligibility:\n\nPeople aged 4 to 70 years with blood cancer caused by a RUNX1 gene mutation. Other participants are also needed: (1) stem cell donors; (2) relatives who do not have a mutation in the RUNX1 gene; and (3) healthy volunteers.\n\nDesign:\n\nParticipants with blood cancer will be screened during approximately 1-3 months before transplatation. They will have blood tests and tests of their heart and lung function. A sample of bone marrow may be taken.\n\nA flexible tube (central line) will be inserted into a vein in participants chest or lower neck. This line will remain in place during the hospitalization and be used to draw blood and administer drugs. These lines are almost always transitioned to a peripherally inserted central catheter (PICC) line at the time of hospital discharge.\n\nParticipants will be inpatient for 4 to 5 weeks. They will receive drugs to prepare their body for the stem cell transplant. Some may also receive radiation treatment. Other tests will include imaging scans. The stem cell transplant will be given through the central line.\n\nAfter discharge from the clinic, participants will have follow-up visits at least once per week for approximately 100 days. Then they will have follow-up clinic visits for 3 years.\n\nDonors, relatives, and healthy volunteers may provide samples of blood, stool, and saliva. Adults may also opt to provide samples of skin and bone marrow.",[183,184,185,186],"Core Binding Factor Alpha Subunits","Hematologic Neoplasms","Leukemia","Lymphoma",[188,189,190,191],"RUNX1","Haploidentical Hematopoietic Stem Cell Transplant","Germline RUNX1","germline RUNX1-aassociated myeloid malignancy","NOT_YET_RECRUITING",{"date":34,"type":35},{"date":95,"type":21},{"date":196,"type":21},"2036-06-01",{"name":41,"class":42},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":204,"maxAge":75,"enrollmentInfo":205,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":208,"conditions":209,"keywords":215,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":223,"leadSponsor":225,"locationsCount":99},"100053593","nci-childhood-cancer-data-initiative-ccdi-led-pediatric-adolescent-and-young-adult-rare-cancer-registry-for-very-rare-solid-tumors-100053593","NCT07489378","NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors","* INCLUSION CRITERIA:\n* History of newly diagnosed (within 1 year of diagnosis) very rare solid tumor (defined as an estimated 2 incident cases per million per year).\n* Age \\>= 1 month and \\\u003C= 39 years at the time of diagnosis.\n* Participants must have established care with a local treating physician.\n* Ability of the participant, parent\u002Fguardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Diagnosis of any of the following at any time:\n\n  * Ewing Sarcoma\n  * Osteosarcoma\n  * Rhabdomyosarcoma\n  * Diffuse midline glioma (H3K27 altered)\n  * Atypical teratoid rhabdoid tumor\n  * Pleuropulmonary blastoma\n  * Common adult cancers that occur in pediatric\u002FAYA populations (i.e., colorectal cancer, breast cancer)\n* The participant is unlikely to comply with the terms of the protocol.","1 Month",{"count":206,"type":21},4000,"OBSERVATIONAL","Background:\n\nAll childhood cancers are rare, but some are called very rare. Very rare cancers are diagnosed in 2 or fewer out of 1 million people each year. Researchers want to gather data so they can learn more about these very rare cancers. They hope to use the data to develop future treatments.\n\nObjective:\n\nTo gather data for a registry of very rare cancers found in children, teens, and young adults.\n\nEligibility:\n\nPeople aged 1 month to 39 years newly diagnosed (within the past year) with a very rare cancer.\n\nDesign:\n\nParticipation will be by phone or email. No clinic visits are required.\n\nResearchers will look at the participant s medical records. They will ask for samples of tumor tissue that were already removed. They will use the samples for genetic testing. The results of these tests will be sent to the participant s own doctors.\n\nSome participants will be asked for saliva or cheek swab samples. They will receive a kit in the mail. They will spit into a tube or swab the inside of their cheek. They will mail the sample back to the lab.\n\nParticipants will fill out questionnaires once a year for 5 years. They will answer questions about:\n\nFamily history, such as other cancers in the family and their income, work, and education.\n\nDemographics, such as their gender, nationality, ethnicity, education, and work history.\n\nSymptoms and treatment for their cancer. This may include level of pain, and emotional and physical well-being.\n\nParticipants data will be added to a secure database for other researchers. Their data will be anonymous.",[210,211,212,213,214],"Very Rare Tumors","Very Rare Cancers","Other Solid Tumors","Solid Tumor","Pediatric Rare Tumors",[216,217,218,219,220],"Longitudinal Study","Registry","Patient Reported Outcomes","Family History","Molecular Characterization",{"date":34,"type":35},{"date":95,"type":21},{"date":224,"type":21},"2037-04-01",{"name":41,"class":42},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":74,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},"100054232","phase-1-trastuzumab-deruxtecan-ds-8201a-for-the-treatment-of-newly-diagnosed-recurrent-or-refractory-osteosarcoma-wilms-tumor-and-desmoplastic-small-round-cell-tumor-100054232","NCT04616560","Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Newly Diagnosed, Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor","A Phase 1\u002F2 Study of DS-8201a (NSC# 807708) in Children, Adolescents, or Young Adults With Recurrent Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor","Inclusion Criteria:\n\n* Phase 1 (Part A): Patients must be at least 2 years and less than 12 years of age at the time of study enrollment\n* Phase 2: Wilms tumor patients (Part B1): All Wilms tumor patients enrolled must be less than 18 years of age at enrollment\n\n  * Until the completion of the Phase 1 dose confirmation, patients must be at least 12 years of age and less than 18 years of age at the time of study enrollment\n  * Following dose confirmation of DS-8201a in children at least 2 to less than 12 years old in the Phase 1 component, Wilms tumor patients at least 2 to less than 18 years of age will be allowed on the Phase 2 component\n* Phase 2: DSRCT patients (Part B2): Until the completion of the Phase 1 component, patients enrolling on the Phase 2 component of the study must be from at least 12 to 39 years of age at the time of study enrollment\n\n  * Following dose confirmation of DS-8201a in children at least 2 to less than 12 years old in the Phase 1 component, DSRCT patients at least 2 to 39 years of age will be allowed on the Phase 2 component\n* Patients must have had histologic verification of Wilms tumor or desmoplastic small round cell tumor at original diagnosis or relapse\n* Solid tumors: Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients with clinically inactive brain metastases may be included in the study. Patients with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Lastly, patient must have unresectable lesions or lesions with no intention to surgically remove the lesions in the 6 months following enrollment\n* Wilms tumor: WT patients must have either refractory disease or a very high risk relapse, defined as ANY of the following:\n\n  * Relapse after initial treatment with 4 or more chemotherapy agents (e.g. Regimens vincristine, dactinomycin, doxorubicin, cyclophosphamide, etoposide and radiation \\[M\\], vincristine, dactinomycin and doxorubicin, vincristine, and irinotecan \\[MVI\\], doxorubicin, vincristine, cyclophosphamide, carboplatin, etoposide and radiation \\[UH-1\\], doxorubicin, vincristine, cyclophosphamide, carboplatin, etoposide, vincristine, and irinotecan \\[UH-2\\], vincristine, irinotecan, cyclophosphamide, carboplatin, etoposide and doxorubicin \\[UH-3\\], and etoposide, carboplatin, cyclophosphamide, and doxorubicin \\[HR-1\\])\n  * Relapse with high risk histology (anaplasia, blastemal predominant)\n  * Multiple relapses\n* Desmoplastic small round cell tumor: DSRCT patients with relapsed or refractory disease are eligible\n* Patient's current disease state must be one for which they have received at least standard initial therapy, defined as systemic therapy combined with either radiation or surgery for local control of the primary tumor at diagnosis. Prior therapy after relapse is not required\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0 or 1. Use Karnofsky for patients older than 16 years of age and Lansky for patients 16 years of age and younger\n* Patients must have recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment\n\n    * \\>= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n  * Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): \\>= 7 days after the last dose of agent\n  * Antibodies: \\>= 4 weeks (28 days) must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\\u003C 1\n  * Corticosteroids\n  * Hematopoietic growth factors: \\>= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): \\>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \\>= 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: \\>= 30 days\n  * Cellular therapy: \\>= 30 days after the completion the infusion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.)\n  * Radiation therapy (XRT)\u002Fexternal beam irradiation including protons: \\>= 4 weeks (28 days) including palliative radiation therapy to the chest. \\>= 14 days after palliative local XRT to areas other than the chest or for whole brain radiotherapy\n  * Radiopharmaceutical therapy (e.g., radiolabeled antibody, samarium): \\>= 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior HER2 therapies including antibody drug conjugates (e.g. TDM-1 or DS-8201a), HER2 directed cellular therapies, HER2 receptor therapy (e.g. trastuzumab, pertuzumab, margetuximab, zanidatamab, zenocutuzumab) or small molecule antagonists of HER2 (e.g lapatinib, tucatinib, or neratinib). Prior exposure to antibody drug conjugates which do not target HER2 as well as prior treatment with topoisomerase 1 inhibitors (e.g. irinotecan, topotecan) are permitted\n* Patients must be at least 14 days from the date of last surgery\n* Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL, (for patients with solid tumors without known bone marrow involvement)\n* Platelet count \\>= 100,000\u002FuL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (for patients with solid tumors without known bone marrow involvement)\n* Hemoglobin \\>= 8.0 g\u002FdL at baseline (Red Blood Cell transfusion is not allowed within 1 week prior to enrollment) (for patients with solid tumors without known bone marrow involvement)\n* For patients less than or equal to 17 years old, \"Bedside\" Schwartz formula (2009)\n* Estimated glomerular filtration rate (GFR) (eGFR) ≥ 70 mL\u002Fmin\u002F1.73 m\\^2 (\\> 70mL\u002Fmin\u002F1.73 m\\^2 for patients \\> 17 years old)\n\n  * For patients older than 17 years of age the Cockroft-Gault equation should be utilized to calculate creatinine clearance ≥ 70 ml\u002Fmin:\n  * OR for any age group:\n\n    * A 24 hour urine creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m\\^2 (\\> 70mL\u002Fmin for patients ≥ 17 years old) OR\n    * A directly measured GFR ≥ 70 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n* Bilirubin (sum of conjugated + unconjugated or total) =\\\u003C 1.5 x upper limit of normal (ULN) for age. For patients with documented Gilbert's syndrome (unconjugated hyperbilirubinemia) bilirubin must be \\\u003C 3 x ULN for age (patients with solid tumors)\n* Aspartate aminotransferase (AST) =\\\u003C 3 x ULN\n* Serum albumin \\>= 2.5 g\u002FdL (patients with solid tumors)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) =\\\u003C 1.5 x ULN. Exception for patients receiving coumarin-derivative anticoagulants or other similar anticoagulant therapy, who must have INR\u002FPT within the therapeutic range as deemed appropriate by the investigator\n* Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\>= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before Step 1 enrollment\n* Corrected QT interval (QTc) prolongation to \\\u003C 480 ms based on average triplicate 12-lead electrocardiogram (ECG)\n* Pulse oximetry \\> 93% on room air\n* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days\n* Nervous system disorders (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5) resulting from prior chemotherapy, surgery, and\u002For radiation must be =\\\u003C grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment are eligible\n* All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines\n\nExclusion Criteria:\n\n* Pregnant, planning to become pregnant, or breast-feeding women will not be entered on this study. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Abstinence is an acceptable method of birth control\n\n  * Methods considered as highly effective methods of contraception include:\n\n    * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:\n\n      * Oral\n      * Intravaginal\n      * Transdermal\n    * Progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n      * Oral\n      * Injectable\n      * Implantable\n    * Intrauterine device (IUD)\n    * Intrauterine hormone-releasing system (IUS)\n    * Bilateral tubal occlusion\n    * Vasectomized partner\n    * Complete sexual abstinence defined as refraining from heterosexual intercourse. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception\n* Non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \\[FSH\\] \\> 40 mIU\u002FmL and estradiol \\\u003C 40 pg\u002FmL \\[\\\u003C 147 pmol\u002FL\\] is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method\n* Male patients must not freeze or donate sperm starting at enrollment and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrolment in this study\n* Female patients must not donate, or retrieve for their own use, ova from the time of enrollment and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who are receiving chloroquine or hydroxychloroquine within 14 days are not eligible for this trial\n* Patients who received a live, attenuated vaccine (messenger ribonucleic acid \\[mRNA\\] and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to enrollment are not eligible for this trial\n\n  * Note: Participants, if enrolled, should not receive live vaccines during the study and up to 90 days after the last dose of study intervention. It is recommended that patients receive a yearly influenza killed vaccination and additional killed vaccinations based on local or national recommendations. Consider vaccination against viral pathogens that cause pneumonias according to local or national guidelines\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients with a medical history of myocardial infarction within 180 days before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV) or troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to enrollment are not eligible\n* Additionally, patients with a history of any of the following congenital heart disease are not eligible:\n\n  * Single ventricle heart defects (hypoplastic left heart syndrome, unbalanced atrioventricular septal defects, double inlet left ventricle, tricuspid atresia, the presence of superior cavopulmonary anastomosis or Fontan palliation);\n  * Unpalliated defects with significant hemodynamic alterations or palliated lesions with residual hemodynamic alterations (ductal-dependent or shunt-dependent physiology, large unrestrictive ventricular septal defect, transposition of the great arteries, greater than moderate atrioventricular valve insufficiency, moderate or greater aortic valve stenosis, moderate or greater aortic valve insufficiency, large atrial septal defects with significant right ventricular volume overload, large patent ductus arteriosus)\n* Patients who have a pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART) are not eligible. (Drainage and concentrated ascites reinfusion therapy are not allowed within 2 weeks prior to enrollment)\n* Patients who have spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms are not eligible\n* Patients with a known history of severe hypersensitivity to DS-8201a, any excipient contained in the DS-8201a drug formulation, or HER2-targeted monoclonal antibodies (trastuzumab, pertuzumab, margetuximab) are not eligible\n* Patients who have an uncontrolled infection or non-healing surgical site are not eligible\n* Patients with a known history of substance abuse or any other clinically significant medical conditions (i.e. psychological conditions) that may, in the opinion of the investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results are not eligible\n* Patients who have pulmonary compromise, ex hypoxia, resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion etc.), or prior pneumonectomy are not eligible\n* Patients who have a history of (non-infectious) ILD (interstitial lung disease)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or for whom suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening are not eligible. Patients who have history of genetic disorders of the lung (i.e. cystic fibrosis are not eligible)\n* Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible\n* Patients with known hepatitis B or C with detectable viral load are not eligible\n* Patients with any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of enrollment or genetic diseases involving the lung are not eligible\n* Patients with an active primary immunodeficiency are not eligible","39 Years",{"count":235,"type":21},55,[79,24],"This phase I\u002FII trial studies the effects of trastuzumab deruxtecan (DS-8201a) in treating patients with osteosarcoma, Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) that is newly diagnosed or has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them.",[239,240,241,242,243,244,245,246],"Desmoplastic Small Round Cell Tumor","Osteosarcoma","Recurrent Desmoplastic Small Round Cell Tumor","Recurrent Kidney Wilms Tumor","Recurrent Osteosarcoma","Refractory Desmoplastic Small Round Cell Tumor","Refractory Wilms Tumor","Wilms Tumor",{"date":34,"type":35},{"date":249,"type":35},"2021-03-08",{"date":251,"type":21},"2027-12-31",{"name":41,"class":42},28,{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":270,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":281,"leadSponsor":283,"locationsCount":99},"100053417","phase-1-neoadjuvant-inhaled-azacytidine-with-platinum-based-chemotherapy-and-durvalumab-medi4736---a-combined-epigenetic-immunotherapy-aza-aegean-regimen-for-operable-early-stage-non-small-cell-lung-cancer-nsclc-100053417","NCT06694454","Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)","Phase I\u002FII Study of Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed, resectable per standard of care stage IB-IIIA non-small cell lung cancer (NSCLC) irrespective of programmed death-ligand 1 (PD-L1) expression. Note: Confirmation is required by NCI Laboratory of Pathology (LP).\n* Willingness to undergo tumor resection surgery per standard of care (SOC) guidelines following induction therapy (platinum chemotherapy and durvalumab).\n* Participants must have disease that can be safely accessed via bronchoscopic, thoracoscopic, or percutaneous biopsy techniques, and be willing to undergo tumor biopsy before treatment.\n* No prior therapy for the NSCLC.\n* Measurable disease per RECIST 1.1\n* Age \\>= 18 years.\n* Body weight \\> 30kg.\n* ECOG Performance Status \\\u003C= 1\n* Participants must have adequate pulmonary reserve evidenced by predicted post-op FEV1 and adjusted DLCO \\>= 40% at screening.\n* Participants must have pCO2 \\\u003C= 45 and pO2 \\>=60 on room air by arterial blood gas (ABG) if O2 sat by pulse oximetry is\\\u003C= 92% on room air at screening.\n* Adequate organ and marrow function as defined below:\n\n  * Leukocytes \\>3,000\u002FmicroL\n  * Absolute neutrophil count \\>1,500\u002FmicroL (without transfusion or cytokine support)\n  * Absolute lymphocyte count \\> 800\u002FmicroL\n  * Platelets \\>100,000\u002FmicroL\n  * Hemoglobin \\>= 9.0 g\u002FdL\n  * Prothrombin time (PT) no more than 2 seconds above the upper limit of normal (ULN)\n  * Total bilirubin OR Direct bilirubin \\\u003C 1.5 X institutional upper limit of normal OR \\\u003C= ULN for participants with total bilirubin \\>= 1.5 ULN\n  * Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) \\\u003C 2.5 X institutional ULN\n  * Serum albumin \\>= 2.0 mg\u002FdL\n  * Creatinine OR Creatinine clearance (eGFR) \\\u003C= 1.6 mg\u002Fml OR \\>60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of the study treatment and up to 6 months after the last dose of the study drug(s). Note: participants who have cisplatin as part of SOC chemo must agree to use a highly effective method of contraception for 14 months.\n\nIndividuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 3 months after the last dose of the study drug(s). Note: participants who have cisplatin as part of SOC chemo must agree to use an effective method of contraception for 11 months. We also will recommend these individuals with partners of childbearing potential to ask partners to be on highly effective birth control (hormonal, intrauterine device (IUD), surgical sterilization).\n\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 3 months after the last dose of the study drug(s).\n* Participants with history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness are included if on appropriate antiretroviral therapy with HIV viral load \\\u003C400 copies\u002FmL.\n* Participants must agree to not donate blood from the study entry and up to 3 months after the last dose of the study drug(s).\n* Participants must be co-enrolled in protocol 06C0014: Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies .\n* The ability of a participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Medically inoperable because of clinical co-morbidities.\n* Participants with T4 tumors invading the diaphragm, mediastinum, carina, trachea, esophagus, heart, great vessels, recurrent laryngeal nerve, or vertebral body.\n* Participants who experienced serious immune adverse events that required discontinuation of immune checkpoint inhibitor therapy for a prior non-NSCLC malignancy.\n* History of known EGFR or ALK alterations in the tumor.\n* History of active autoimmune disease including colitis, nephritis, hypophysitis, or neuropathy, with the exceptions of:\n\n  --Diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment.\n* History of pneumonitis or interstitial lung disease.\n* Clinically significant cardiovascular\u002Fcerebrovascular disease as follows:\n\n  * cerebral vascular accident\u002Fstroke (within 6 months prior to study treatment initiation)\n  * myocardial infarction (within 6 months prior to study treatment initiation)\n  * unstable angina, congestive heart failure (New York Heart Association Classification Class \\>= II, https:\u002F\u002Fmanual.jointcommission.org\u002Freleases\u002FTJC2016A\u002FDataElem0439.html#:\\~:text=Class%20II%20%2D%20Mild%20symptoms%20(mild,Class%20IV%20%2D%20Severe%20limitations), serious cardiac arrhythmia, clinically significant bleeding or clinically significant pulmonary embolism at screening.\n* Active Hepatitis A (HAV), Hepatitis B (HBV) (HbsAg reactive), or Hepatitis C (HCV) (HCV RNA \\[qualitative\\] is detected) at screening.\n* Other active infections requiring systemic therapy at screening.\n* Positive beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.\n* Systemic corticosteroids at doses above physiologic levels (\\> 10 mg of prednisone or equivalent per day), or inhaled corticosteroids within 14 days before study treatment initiation. Administration of steroids through a route known to result in a minimal systemic exposure (i.e., topical, intro-ocular, or intra-articular) is allowed.\n* Major surgical procedure within 28 days prior to the study treatment initiation. Note: Local surgery of isolated lesions for palliative intent is acceptable provided other site(s) of disease is available for response assessment.\n* History of allogenic organ transplantation.\n* History of another primary malignancy except for malignancy treated with curative intent and with no known active disease \\>= 5 years before the study treatment initiation.\n* Administration of live attenuated vaccines within 30 days prior to study treatment initiation. Note: Administration of inactivated vaccines (e.g., inactivated influenza vaccines) is permitted before or during the study.\n* Administration of investigational drug on other clinical trial within 14 days prior to study treatment initiation.\n* History of hypersensitivity to Mannitol.\n* Herbal and natural remedies that may have immune-modulating effects within 7 days prior to study treatment initiation.\n* Uncontrolled intercurrent illness evaluated by history and physical exam or situation that would limit compliance with study requirements.",{"count":151,"type":21},[79,24],"Background:\n\nLung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors, many recur (happen again). An FDA-approved drug combination to treat early-stage NSCLC prior to the surgery is durvalumab plus standard chemotherapy. The FDA approved infusion drug azacytidine \\[AZA\\] is used to treat several diseases because it can rapidly kill dividing cells (including cancer cells) but it is not approved for NSCLC. An inhaled (aerosolized) form of AZA is also not approved for NSCLC. However, researchers want to know if an inhaled version of AZA can help improve treatment of people with NSCLC because inhaled AZA goes directly into the lungs with limited absorption into the bloodstream.\n\nObjective:\n\nTo find the safest and most effective dose of inhaled AZA in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery.\n\nEligibility:\n\nAdults aged 18 and older with operable early-stage NSCLC. Participants will be required to also enroll in NIH protocol 06C0014 which allows for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. Participants will be required to have a tissue sample (biopsy) taken of their tumor prior to receiving study drug and again during surgery after Cycle 3; airway tissue biopsies and collection of collect bronchial (lung) fluid may also be done.\n\nParticipants will receive the study treatment for 3 cycles. Each cycle is 21 days. They will need to come to the NIH Clinical Center (CC) on days 1-4 of Cycles 1-3.\n\nAZA will be given as a drug mist that can be inhaled (like the type of mist in an asthma inhaler) using a nebulizer at the NIH Clinical Center (CC) for 3 days in a row (consecutive days) during the first week of each cycle. The participant will inhale the AZA drug mist for 20 to 30 minutes each time. Participants will also receive durvalumab and a specific 2-drug assigned chemotherapy by intravenous (IV) infusion on day 4 of each cycle.\n\nParticipants will have a follow-up visit 2 weeks after their last dose of study drugs. Then they will have planned surgery to remove the tumors.\n\nParticipants will have additional follow-up visits at the NIH CC about 1 and 3 months after the surgery, and then for every 3 months for up to 3 years.",[265,266,267,268,269],"Non-small Cell Lung Cancer (NSCLC)","Carcinoma, Non-Small Cell Lung","Non-Small Cell Lung Carcinoma","Non Small Cell Lung Cancer","Non Small Cell Lung Carcinoma",[271,272,273,274,275,276,277,278],"immune checkpoint inhibitor (CPI)","pathologic complete response (pCR)","aerosolized drug delivery","immunosuppressive tumor microenvironment (TME)","reversible epigenetic mechanisms","DNA demethylating agents","nebulizer treatment","AZA",{"date":34,"type":35},{"date":95,"type":21},{"date":282,"type":21},"2034-12-31",{"name":41,"class":42},{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":291,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":305},"100053655","phase-3-a-study-to-compare-standard-therapy-to-treat-hodgkin-lymphoma-to-the-use-of-two-drugs-brentuximab-vedotin-and-nivolumab-100053655","NCT05675410","A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab","A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma","Inclusion Criteria:\n\n* Patients must be 5 to 60 years of age at the time of enrollment\n* Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \\[NOS\\]) with stage I or II disease\n* Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \\>= 1.5 cm)\n* Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained\n* Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease.\n\n  * Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality.\n* Patients \\>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2\n* Patients =\\\u003C 17 years of age must have a Lansky performance score of \\>= 50\n* Pediatric patients (age 5-17 years): A serum creatinine based on age\u002Fsex as follows (within 28 days prior to enrollment):\n\n  * 2 to \\\u003C 6 years (age): 0.8 mg\u002FdL (male), 0.8 mg\u002FdL (female)\n  * 6 to \\\u003C 10 years (age): 1 mg\u002FdL (male), 1 mg\u002FdL (female)\n  * 10 to \\\u003C 13 years (age): 1.2 mg\u002FdL (male), 1.2 mg\u002FdL (female)\n  * 13 to \\\u003C 16 years (age): 1.5 mg\u002FdL (male), 1.4 mg\u002FdL (female)\n  * \\>= 16 years (age): 1.7 mg\u002FdL (male), 1.4 mg\u002FdL (female) OR a 24 hour urine creatinine clearance \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 (within 28 days prior to enrollment) OR a glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 (within 28 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n  * Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* For adult patients (age 18 years or older) (within 28 days prior to enrollment): Creatinine clearance \\>= 30 mL\u002Fmin, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (within 28 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome\n* Aspartate aminotransferase (AST) =\\\u003C 3 x ULN (within 28 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome\n* Alanine aminotransferase (ALT) =\\\u003C 3 x ULN (within 28 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome\n* Shortening fraction of \\>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 28 days prior to enrollment) or ejection fraction of \\>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 28 days prior to enrollment)\n* Diffusion capacity of the lung for carbon monoxide (DLCO) \\>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 28 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \\> 92% on room air\n* Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n\nExclusion Criteria:\n\n* Patients with nodular lymphocyte predominant Hodgkin lymphoma\n* Patients with a history of active interstitial pneumonitis or interstitial lung disease\n* Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients\n* Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and\u002For absorption of pills\n* Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \\> 10 mg daily predniSONE for patients \\>= 18 years or \\> 0.5 mg\u002Fkg \\[up to 10 mg\u002Fday\\] for patients \\\u003C 18 years) or other immunosuppressive medications within 14 days prior to enrollment\n\n  * Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\\\u003C 10 mg daily for patients \\>= 18 years or =\\\u003C 0.5 mg\u002Fkg \\[up to 10 mg\u002Fday\\] predniSONE equivalents) are permitted in the absence of active autoimmune disease\n  * Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1\n  * Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids.\n* Patients with peripheral neuropathy \\> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL\n* Prior solid organ transplant\n* Prior allogeneic stem cell transplantation\n* Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \\[BCG\\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment\n* Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer\n\n  * Men and women of childbearing potential (WOCBP) must use effective contraception during the study and for 2 months for WOCBP and 4 months for men, after last dose of brentuximab vedotin\n  * WOCBP must continue contraception for a period of at least 5 months after the last dose of nivolumab\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","5 Years","60 Years",{"count":294,"type":21},1875,[55],"This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and\u002For fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.",[298],"Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8",{"date":34,"type":35},{"date":301,"type":35},"2023-05-11",{"date":303,"type":21},"2031-04-28",{"name":41,"class":42},407,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},"100054299","phase-2-testing-the-addition-of-radiation-therapy-to-the-usual-immune-therapy-treatment-atezolizumab-for-extensive-stage-small-cell-lung-cancer-the-raptor-trial-100054299","NCT04402788","Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial","RAndomized Phase II\u002FIII Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial","Inclusion Criteria:\n\n* Any confirmation (cytologic, histologic, or pathologic) of extensive stage small cell lung cancer at any site, either primary or metastases\n* Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide\u002Fplatinum (E\u002FP) doublet plus atezolizumab by re-staging scans (positron emission tomography \\[PET\\]\u002Fcomputed tomography \\[CT\\] scan, diagnostic CT scan, magnetic resonance imaging \\[MRI\\] optional per treating physician); atezolizumab should continue through randomization. Patients must be randomized within 9 weeks of last dose of etoposide\u002Fplatinum (if not receiving PCI) or 6 weeks from completion of prophylactic cranial irradiation (PCI)\n\n  * NOTE: Patients must have at least 3 cycles of E\u002FP plus atezolizumab. They can have one cycle of induction E\u002FP without concurrent atezolizumab if unable to receive concurrent E\u002FP combined with atezolizumab for all cycles of induction therapy\n* Patients must have measurable disease (per Response Evaluation Criteria in Solid Tumors \\[RECIST\\]) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment\n* At time of enrollment after induction E\u002FP chemotherapy and atezolizumab, if there is a pleural effusion, patients will be eligible if thoracentesis is cytologically negative or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT\u002FPET imaging\n* Appropriate stage for study entry based on the following diagnostic workup:\n\n  * History\u002Fphysical examination within 14 days prior to registration;\n  * Imaging within 42 days prior to registration to include:\n\n    * MRI brain with contrast or CT brain with contrast\n    * CT chest, abdomen and pelvis or whole body PET\u002FCT scan any time after the fourth cycle of chemotherapy and prior to registration\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fcells\u002Fmm\\^3 (within 14 days prior to registration)\n* Platelets \\>= 75,000 cells\u002Fmm\\^3 (within 14 days prior to registration)\n* Hemoglobin \\>= 8 g\u002FdL (within 14 days prior to registration)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x ULN (AST and\u002For ALT =\\\u003C 5 ULN for patients with liver involvement) (within 14 days prior to registration)\n* Alkaline phosphatase =\\\u003C 2.5 x ULN (=\\\u003C 5 ULN for patients with documented liver involvement or bone metastases) (within 14 days prior to registration)\n* Adequate renal function = Creatinine clearance \\>=40 mL\u002Fmin by the Cockcroft-Gault (C-G) equation: (within 14 days prior to registration)\n* Upfront radiation therapy of symptomatic metastatic site is permissible if causing symptoms such as pain or impending fracture\n* Patients with brain metastases are eligible after receiving whole brain radiation before enrollment (anytime during induction systemic therapy). Whole brain radiation can be delivered with hippocampal sparing or 3-D conformal technique. Patients with irradiated brain metastases are eligible if they are clinically stable from a neurological standpoint after completing radiotherapy (e.g. not having uncontrolled seizures) and do not require use of steroids above a dose of 10 mg of prednisone daily\n* For women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to registration.\n\n  * Note: Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n    * Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\n    * Women \\>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\> 1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)\n* Patients positive for human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months and a stable regimen of highly active anti-retroviral (HAART) HIV-positive patients must have no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n\nExclusion Criteria:\n\n* Metastatic disease invading the liver (\\> 3 metastases), heart or \\> 10 metastatic sites detectable after induction systemic therapy. Each visible bone metastasis on radiographic scan counts as one site\n* Patients with a concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen with atezolizumab or radiation\n* Prior radiotherapy in the thorax that would result in overlapping RT fields, unless the overlapping fields meet acceptable dose constraints for normal tissue\n* Active autoimmune disease, including, but not limited to: systemic lupus erythematosus; rheumatoid arthritis; inflammatory bowel disease (e.g. Crohn's, ulcerative colitis); vascular thrombosis associated with antiphospholipid syndrome; Wegener's granulomatosis; Sjogren's syndrome; Guillain-Barre syndrome; multiple sclerosis; vasculitis; or glomerulonephritis.\n\n  * If the autoimmune disease is not active for over 3 years and the patient is not receiving immunosuppressive treatment such as methotrexate or steroids above a dose equivalent to 10 mg prednisone daily, the patient is eligible.\n  * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible\n  * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible\n  * Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations are excluded only if they have active disease with acute exacerbation and on immunosuppressive medications within the 12 months prior to enrollment. They are eligible otherwise.\n* Severe, active co-morbidity defined as follows:\n\n  * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;\n  * Active tuberculosis;\n  * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\n\n    * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive anti-HBc \\[antibody to hepatitis B core antigen\\] antibody test) are eligible\n    * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test)\n  * Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL);\n  * Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of \\> 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary;\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 3 months;\n  * History of recent myocardial infarction within 6 months prior to registration.\n  * Clinically significant interstitial lung disease\n* Pregnancy: Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 5 months (150 days) after the last dose of study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Women who are breastfeeding and unwilling to discontinue\n* History of allogeneic organ transplant\n* Patients who have had immunotherapy-induced pneumonitis",{"count":314,"type":21},138,[24,55],"This phase II\u002FIII trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.",[318],"Extensive Stage Lung Small Cell Carcinoma",{"date":34,"type":35},{"date":321,"type":35},"2021-01-07",{"date":323,"type":21},"2027-04-30",{"name":41,"class":42},416,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":346},"100053573","phase-2-treatment-with-amivantamab-and-hyaluronidase-or-cetuximab-for-advanced-skin-cancer-in-people-with-a-weakened-immune-system-100053573","NCT07042295","Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System","A Randomized Phase II Study of Amivantamab (JNJ-61186372) and Hyaluronidase (rHuPH20) Versus Cetuximab in Immunocompromised Participants With Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Participants must have pathologically proven diagnosis of cutaneous squamous cell carcinoma based on pathology from original diagnosis or from a metastatic\u002Frecurrent lesion\n* Participants must have measurable or non-measurable disease per RECIST 1.1 and must have their disease assessed by CT of chest\u002Fabdomen\u002Fpelvis (with contrast unless contraindicated) within 28 days prior to registration for measurable disease or within 42 days prior to registration for non-measurable disease. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Any lesions assessed using a non-diagnostic positron emission tomography (PET)\u002FCT of chest\u002Fabdomen\u002Fpelvis will be considered non-measurable lesions. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration to be considered measurable\n\n  * NOTE: All diseases must be assessed and documented on the baseline tumor assessment form\n* Participants with exclusively locally recurrent disease must have either a contraindication to surgical treatment of lesions (i.e., complete resection is not possible or not expected to be clinically beneficial or resection conferring significant cosmetic or functional concerns) or have refused surgical or radiation treatment\n* Participants must be immunocompromised, defined as below. For cases where there is a lack of clarity, it is highly recommended study teams reach out to Drs. Swiecicki and Geiger for discussion:\n\n  * An active diagnosis of either chronic lymphocytic leukemia (CLL) or acute leukemia, regardless of whether actively receiving therapy OR\n  * A diagnosis of lymphoma or multiple myeloma either on antineoplastic therapy, or within 6 months after therapy completion OR\n  * Recipient of an organ transplant (excluding corneal transplants or lung transplants)\n\n    * If a transplant patient, documentation from the patient's transplant physician confirming that the patient's allograft is stable. Documentation must be dated within 180 days of registration OR\n  * Autoimmune disease under active treatment with an immunosuppressive medication (as defined below)\n\n    * Autoimmune diseases include but are not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, myasthenia gravis, Guillain-Barre syndrome, autoimmune hepatitis, scleroderma, primary biliary cirrhosis, pemphigus, and bullous pemphigoid\n\n      * Vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma\u002Fatopy are not eligible diagnoses\n    * Immunosuppressant medications include the following:\n\n      * Tumor necrosis factor (TNF) inhibitors (adalimumab, certolizumab, etanercept, golimumab, and infliximab)\n      * Interleukin inhibitors (anakinra, ustekinumab, secukinumab, sarilumab, siltuximab, sulfasalazine, tildrakizumab, tocilizumab, chloroquine, and hydroxychloroquine)\n      * Janus kinase (JAK) inhibitors (baricitinib, filgotinib, and tofacitinib)\n      * Calcineurin inhibitors (cyclosporine and tacrolimus)\n      * Metabolic inhibitors (azathioprine, leflunomide, mercaptopurine, methotrexate)\n      * mTOR (mammalian target of rapamycin) inhibitors (sirolimus \\[rapamycin\\], everolimus, and zotarolimus)\n      * Inosine monophosphate dehydrogenase inhibitors (mycophenolate)\n      * Phosphodiesterase inhibitors (apremilast)\n      * B cell inhibitors (rituximab)\n      * T cell inhibitors (abatacept)\n      * Glucocorticoids\n    * Active treatment is defined as current use of any one or more of the following:\n\n      * Oral glucocorticoid therapy (Prednisone equivalent \\> 10 mg\u002Fday) for 30 days prior to registration\n      * Oral or subcutaneous immunosuppressive therapy for 90 days or more prior to registration\n      * Two or more doses of intravenous non corticosteroid immunosuppressant within 90 days prior to registration\n* Participants with treated brain metastases must show no evidence of progression on follow-up brain imaging after central nervous system (CNS)-directed therapy\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate CNS specific treatment at the time of study registration or anticipated during the first cycle of therapy\n* Participants must not have had prior treatment with cetuximab or another EGFR inhibitor within the last 365 days\n* Participant must be ≥ 18 years old at the time of registration\n* Participant must have Zubrod Performance Status of 0-2\n* Participant must have a complete medical history and physical exam within 28 days prior to registration\n* Leukocytes ≥ 3 x 10\\^3\u002FuL (within 14 days prior to registration)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 14 days prior to registration)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 14 days prior to registration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 14 days prior to registration)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 × institutional ULN with the exception of subjects with documented liver metastases: AST and\u002For ALT ≤ 5.0 x institutional ULN (within 14 days prior to registration)\n* Participants must have a measured OR calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 14 days prior to registration\n* Participants must not have an active or past medical history of interstitial lung disease (ILD)\u002Fpneumonitis, including drug-induced or radiation ILD\u002Fpneumonitis\n* Participants must not have a history of lung transplantation\n* Participants must not have a history of pulmonary graft versus host disease (GVHD)\n* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* Participants with a history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants with a history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* Participants must not have an uncontrolled illness, including but not limited to:\n\n  * Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy \\[participants will be required to complete antibiotics 1 week prior to starting study treatment\\])\n  * Active bleeding diathesis\n  * Any ophthalmologic condition that is clinically unstable\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped) due to known toxicities of amivantamab. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen. Participants must agree not to donate ova or sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment. For female participants of childbearing potential, a negative pregnancy test is required within 72 hours prior to registration\n* Participants must be offered the opportunity to participate in specimen banking",{"count":334,"type":21},86,[24],"This phase II trial compares the effect of amivantamab and hyaluronidase to cetuximab for the treatment of skin (cutaneous) squamous cell carcinoma that has come back after a period of improvement and has not spread to other parts of the body (locally recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Amivantamab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Hyaluronidase is an endoglycosidase. It helps to keep amivantamab in the body longer, so that the medications will have a greater effect. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Giving amivantamab and hyaluronidase may be as effective as cetuximab for the treatment of locally recurrent or metastatic cutaneous squamous cell carcinoma.",[338,339],"Locally Recurrent Skin Squamous Cell Carcinoma","Metastatic Skin Squamous Cell Carcinoma",{"date":34,"type":35},{"date":342,"type":35},"2026-03-23",{"date":344,"type":21},"2029-02-28",{"name":41,"class":42},38,{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},"100053572","phase-3-induction-pembrolizumab-and-chemotherapy-followed-by-pembrolizumab-before-chemoradiation-and-pembrolizumab-maintenance-compared-to-standard-chemoradiation-with-pembrolizumab-followed-by-pembrolizumab-maintenance-in-high-risk-cervical-cancer-100053572","NCT07061977","Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer","NRG-GY037: A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab Versus Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n* Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma\n* Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement:\n\n  * IIIA (T3aN0M0)\n  * IIIB (T3bN0M0)\n  * IIIC1(T3aN1M0, T3bN1M0)\n  * IIIC2 (T3aN2M0, T3bN2M0)\n  * IVA (T4aN0M0, T4aN1M0, T4aN2M0) No prior hysterectomy defined as removal of the entire uterus.\n  * NOTE: prior partial\u002Fsubtotal hysterectomy for reasons other than cervical cancer are eligible to participate in the study. No plan to perform a hysterectomy as part of initial cervical cancer therapy.\n\nNo paraaortic lymph node (PALN) metastases above the T12\u002FL1 interspace.\n\n* Note: Nodal status can be confirmed by imaging (CT, MRI, or PET\u002FCT), fine needle aspirate\u002Fcore biopsy, extra peritoneal biopsy, laparoscopic biopsy, or lymphadenectomy.\n\nRadiologic definition of lymph node staging:\n\n* N1:\n\n  * One or more pelvic lymph nodes with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and\u002For\n  * One or more pelvic lymph nodes with short axis diameter of ≥ 10 mm and standardized uptake value maximum (SUVmax) ≥ 2.5 by fludeoxyglucose (FDG)-PET\n* N2:\n\n  * One or more para-aortic lymph node with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and\u002For\n  * One or more para-aortic lymph node with short axis diameter of ≥ 10 mm and SUVmax ≥ 2.5 by FDG-PET\n\n    * No prior definitive surgical, radiation, or systemic therapy for cervical cancer\n    * No prior immunotherapy\n    * No prior pelvic radiation therapy for any disease\n    * Age ≥ 18\n    * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n    * Not pregnant and not nursing\n    * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n    * Platelets ≥ 100,000 cells\u002Fmm\\^3\n    * Hemoglobin ≥ 8 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobulin \\[Hgb\\] ≥ 8 g\u002Fdl is acceptable)\n    * Creatinine clearance (CrCL) of ≥ 50 mL\u002Fmin by the Cockcroft-Gault formula\n    * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN\n    * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n    * No active infection requiring parenteral antibiotics\n    * No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacille Calmette Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed\n    * No diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior registration\n    * No active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n    * No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis\n    * No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)",{"count":355,"type":21},336,[55],"This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding induction chemotherapy to the usual treatment of chemotherapy and radiation followed by maintenance may be more effective in treating patients with high risk, locally advanced cervical cancer.",[359,360,361,362,363,364,365,366],"Locally Advanced Cervical Adenocarcinoma","Locally Advanced Cervical Adenosquamous Carcinoma","Locally Advanced Cervical Squamous Cell Carcinoma","Stage IIIA Cervical Cancer FIGO 2018","Stage IIIB Cervical Cancer FIGO 2018","Stage IIIC1 Cervical Cancer FIGO 2018","Stage IIIC2 Cervical Cancer FIGO 2018","Stage IVA Cervical Cancer FIGO 2018",{"date":34,"type":35},{"date":369,"type":35},"2025-11-05",{"date":371,"type":21},"2030-12-31",{"name":41,"class":42},295,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":381,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":388,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":393,"leadSponsor":395,"locationsCount":99},"100053794","phase-1-anti-crlf2-rtslpr-chimeric-antigen-receptor-t-cells-tslpr-cart-in-participants-with-recurrent-or-refractory-crlf2-rtslpr-overexpressing-b-cell-acute-lymphoblastic-leukemia-b-all-100053794","NCT07572136","Anti-CRLF2-R\u002FTSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R\u002FTSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)","Phase I Dose Escalation Study of Anti-CRLF2-R\u002FTSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R\u002FTSLPR-Overexpressing B-cell Acute Lymphoblastic Leukemia (B-ALL)","* INCLUSION CRITERIA:\n\n  1. Documentation of pathologic confirmation of a diagnosis of B-Cell acute lymphoblastic leukemia (ALL).\n  2. TSLPR+ expression must be detected on \\>=80% of the malignant cells by NSR device. Note: TSLPR+ expression does not need to be repeated by NSR device if there is a documentation of TSLPR surface expression by flow cytometry from a Clinical Laboratory Improvement Amendments (CLIA) approved laboratory.\n  3. Participants must have a disease that is relapsed or refractory after initial systemic therapy and at least one salvage treatment, and must either be ineligible for, cannot access in a timely manner, or declined alternative curative options (including commercial CAR Tcell constructs\\*, and\u002For have relapsed after allogeneic HSCT).\n\n     \\*Individuals that are CD19 positive will be considered for this study, However, these individuals should be ineligible for, unable to obtain in a timely manner, cannot access, unwilling to undergo, or have failed prior FDA approved CD19 CAR constructs.\n  4. Participants must have measurable or evaluable disease at the screening, defined by any evidence of MRD or positron emission tomography (PET)-avid extramedullary disease\n  5. Age \\>= 18 years\n  6. Clinical performance status: Karnofsky \\>= 50%. Participants who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for the purpose of calculating the performance score.\n  7. Participants must have adequate organ and marrow function as defined below:\n\n     * Leukocytes \\>= 750\u002FmcL\\*\n     * Platelets \\>= 50,000\u002FmcL\\*\n     * Total bilirubin \\\u003C= 2 x upper limit of normal (ULN) (except in the case of participants with documented Gilbert s disease \\> 3 X ULN)\n     * Aspartate Aminotransferase (AST)\u002FAlanine Aminotransferase (ALT) \\\u003C= 5 X institutional ULN\n     * Creatinine \\\u003C 1.5X ULN OR Creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73m\\^2 for participants with creatinine levels above max listed above\n\n       * A participant will not be excluded because of pancytopenia \\>=Grade 3 if it is due to underlying bone marrow involvement by leukemia\n  8. Cardiac function: left ventricular ejection fraction (LVEF) \\>=45% or fractional shortening \\>= 28%, and no clinically significant electrocardiogram (EKG) findings\n  9. Pulmonary Function: Baseline oxygen saturation \\> 92% on room air at rest without oxygen supplementation\n  10. Participants with the following central nervous system (CNS) status are eligible:\n\n      * CNS 1, defined as absence of blasts in CSF on cytospin preparation, regardless of the number of WBCs;\n      * CNS 2, defined as presence of \\\u003C 5\u002FmcL WBCs in CSF and cytospin positive for blasts, or \\> 5\u002FmcL WBCs but negative by Steinherz\u002FBleyer algorithm:\n\n        * CNS 2a: \\\u003C 10\u002FmcL red blood cells (RBCs); \\\u003C 5\u002FmcL WBCs and cytospin positive for blasts;\n        * CNS 2b: \\>=10\u002FmcL RBCs; \\\u003C 5\u002FmcL WBCs and cytospin positive for blasts;\n        * CNS 2c: \\>=10\u002FmcL RBCs; \\>= 5\u002FmcL WBCs and cytospin positive for blasts but negative by Steinherz\u002FBleyer algorithm.\n  11. Contraception:\n\n      * Women of child-bearing potential (WOCBP) must agree to use a highly effective contraception (hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) at the study entry and up to 12 months after the last dose of combined chemotherapy. Note: WOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n      * Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and for 4 months after the last dose of study drugs. We also will recommend men ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Men able to father a child must not freeze or donate sperm within the same period.\n  12. Nursing participants must be willing to discontinue nursing from study treatment initiation through 1 month after the last dose of the study drug(s).\n  13. Ability and willingness of participant or Legally Authorized Representative (LAR) to co-enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n  14. Participant or LAR must understand and sign a written informed consent.\n\n      EXCLUSION CRITERIA:\n\n  \u003C!-- -->\n\n  1. Recurrent or refractory leukemia limited to isolated testicular or isolated CNS disease\n  2. CNS 3 disease including participants with radiologically detected active CNS lymphoma, or participants who have cranial nerve palsy from active CNS leukemia. Note: Chronic complications of prior CNS disease are not exclusionary in the absence of active disease (e.g., blindness from prior ocular CNS disease or persistent cranial nerve palsy)\n  3. Hyperleukocytosis (\\>=50,000 blasts\u002FmcL)\n  4. Positive serum or urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test performed in WOCBP at screening.\n  5. Washout criteria (time prior to apheresis or prior to start of LD if apheresis is not done on this protocol):\n\n     ====\n\n     Therapy: Systemic chemotherapy, antineoplastic investigational agents, or antibody-based therapies, any investigational therapy\n\n     Washout\\*: \\>= 2 weeks\n\n     Exceptions: 6 weeks for clofarabine or nitrosoureas No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance type chemotherapy (vincristine, 6- mercaptopurine, oral methotrexate, or a tyrosine kinase for participants with Ph+ or Ph-like ALL) provided there is recovery from any acute toxic effects.\n\n     ====\n\n     Therapy: Radiation therapy\n\n     Washout\\*: \\>= 3 weeks\n\n     Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable\u002Fevaluable disease outside the radiation window.\n\n     ====\n\n     Therapy: History of allogeneic HSCT\n\n     Washout\\*: \\>=100 days since HSCT; \\>=30 days since completion of immunosuppression; \\>=6 weeks since donor lymphocyte infusion (DLI)\n\n     ====\n\n     Therapy: History of prior CAR therapy or other adoptive cell therapies\n\n     Washout\\*: \\> 30 days post infusion\n     * Time between prior therapy and apheresis or prior to start of LD if apheresis is not done on this protocol.\n  6. Human immunodeficiency virus (HIV) infection, as measured by seropositivity for HIV antibody.\n  7. Hepatitis B virus (HBV) infection, as measured by positivity for hepatitis B surface antigen (HbsAg).\n  8. Hepatitis C virus (HCV) infection, as measured by seropositivity for hepatitis C.\n  9. Active second malignancy with the exception of in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.\n  10. History of severe, immediate hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.\n  11. Evidence of active graft-versus- host disease (GVHD).\n  12. Uncontrolled, symptomatic, intercurrent illness or social situations as evaluated by medical history, physical exam, and laboratory evaluations that would limit compliance with study requirements or would pose an unacceptable risk to the participant.",{"count":382,"type":21},57,[79],"Background:\n\nB-cell acute lymphoblastic leukemia (B-ALL) is a type of blood cancer. Some people with B-ALL have a gene mutation that makes the disease hard to treat. The mutation causes cancer cells to make too much of a protein called thymic stromal lymphopoietin receptor (TSLPR). Chimeric antigen receptor (CAR) T cell therapy is a treatment that takes immune cells (T cells) from a person s body and modifies them to attack specific proteins. Researchers want to test whether TSLPR-CART cells can be given safely to adults with forms of B-cell leukemia, and to learn whether the treatment may help fight these cancers.\n\nObjective:\n\nTo test TSLPR-CART in people with B-ALL.\n\nEligibility:\n\nPeople aged 18 years and older with B-ALL that did not respond or returned after treatment. They must have TSLPR on their B-ALL.\n\nDesign:\n\nParticipants will be screened. They will have imaging scans and tests of their heart function. Samples will be taken from their bone marrow. They will have a lumbar puncture: A needle will be inserted into their back to collect a sample of the fluid around the spinal cord.\n\nParticipants will undergo leukapheresis: Blood will be taken from their body through a tube. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different tube. The T cells will be used to create TSLPR-CART.\n\nParticipants will take chemotherapy over 5 days to prepare their body for the therapy; then they will receive the modified cells through a tube inserted into a vein. Staying in the hospital during part of the treatment is expected and participants will be monitored locally to evaluate for side effects. Approximately 1 month after receiving TSLPR-CART, participants will undergo evaluations to see how the TSLPR-CART impacted their leukemia. Participants will have follow-up visits for 2 years after TSLPR-CART either at NIH or at home....",[386,387],"B-All","Acute Lymphoblastic Leukemia",[389,390,387,386],"Adoptive Immunotherapy","CRLF2-R\u002FTSLPR Expressing Tumor",{"date":34,"type":35},{"date":95,"type":21},{"date":394,"type":21},"2032-06-30",{"name":41,"class":42},{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":419},"100054062","phase-3-osimertinib-with-or-without-bevacizumab-as-initial-treatment-for-patients-with-egfr-mutant-lung-cancer-100054062","NCT04181060","Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer","Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Patient must have a pathologically-confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)\n* Patient must have advanced disease, defined as - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)\u002FInternational Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria\n* Patient must have somatic activating sensitizing mutation in EGFR (e.g. but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Test results originating from a Clinical Laboratory Improvement Act (CLIA)-certified or similarly accredited laboratory are acceptable; no specific assay is mandated. Plasma, cytology, or tumor tissue can be utilized for mutation testing\n* Patient must not have received any prior treatment with an anti-VEGF agent\n\n  * NOTE: Prior treatment with an EGFR TKI is not allowed, however if a candidate for this study has already started osimertinib within 21 days prior to randomization, the exact osimertinib start date is known, and the patient had the required study baseline imaging completed prior to the osimertinib start date, the patient will be eligible\n* Patients that have received prior radiation therapy are eligible. Radiation (limited field stereotactic radiation or conventional radiation) must have been completed at least one week prior to study drug initiation and more extensive field radiation (i.e., whole-brain radiotherapy \\[WBRT\\]) must have been completed at least two weeks prior to drug initiation\n* Patient must not have any risk factors for anti-VEGF administration, specifically, hemoptysis, active cardiovascular disease, uncontrolled hypertension, significant proteinuria (screening urinalysis \\> 300 mg\u002Fdl) and tumor invading major blood vessels\n* Patient must have measurable disease. Baseline measurements of sites of disease must be obtained within 4 weeks prior to study randomization. If a potential target lesion is previously irradiated without subsequent growth and\u002For is radiated after the imaging from which baseline measurements are obtained, they cannot be included as target lesions, and additional target lesions are required to meet criteria for measurable disease\n* Patient must not have had any prior systemic treatment for metastatic disease\n* Patient must be ≥ 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n* All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n* A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for 2 weeks prior to the start of treatment, while on study treatment, and for\n\n  * 6 weeks after the last dose of protocol treatment for female patients on the osimertinib (AZD9291) alone arm\n  * 4 months after the last dose of protocol treatment for male patients on osimertinib (AZD9291) alone arm\n  * 6 months after the last dose of protocol treatment for all patients on osimertinib (AZD9291) plus bevacizumab combination arm\n  * NOTE: Female patients should also not breastfeed while on treatment and for 6 months after the last dose bevacizumab\n* Leukocytes \\>= 3,000\u002FmcL (obtained =\\\u003C 14 days prior to randomization)\n* Absolute neutrophil count \\>= 1,500\u002FmcL (obtained =\\\u003C 14 days prior to randomization)\n* Platelets \\>= 100,000\u002FmcL (obtained =\\\u003C 14 days prior to randomization)\n* Hemoglobin \\>= 9 g\u002FdL (obtained =\\\u003C 14 days prior to randomization)\n* Total bilirubin and creatinine =\\\u003C 1.5 x institutional upper limit of normal (ULN) (obtained =\\\u003C 14 days prior to randomization)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN (obtained =\\\u003C 14 days prior to randomization)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if neurologically stable without glucocorticoid therapy after the stated washout period from radiation therapy (RT) or surgery provided the metastatic lesions are non-hemorrhagic\n* Patients with untreated brain metastases or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required provided the metastatic lesions are non-hemorrhagic and are neurologically stable without glucocorticoid therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patient must have the ability to understand and the willingness to sign a written informed consent document and comply with study requirements\n* Patient must not have had treatment with any investigational drug within five half-lives or 3 months (whichever is greater), prior to study initiation\n* Patient must not be currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. For any patient currently receiving such inducers of CYP3A4, they must discontinue use prior to first dose of study treatment. All patients must try to avoid concomitant use of any medications, herbal supplements and\u002For ingestion of foods with known inducer effects on CYP3A4\n* Patient must not have any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of randomization, with the exception of alopecia and grade 2 prior platinum-therapy-related neuropathy\n* Patient must not have any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it challenging for the patient to participate in the study. Screening for chronic conditions is not required\n* Patient must not have refractory nausea and vomiting, chronic gastrointestinal diseases, the inability to swallow the osimertinib tablets or previous significant bowel resection that would preclude adequate absorption of osimertinib\n* Patient must not have a medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\n* Patient must not have a history of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib\n* Patient must not have mean resting corrected QT interval (QTc) \\> 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value (using Bazett's correction)\n* Patient must not have any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second-degree heart block\n* Patient must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: potassium \\\u003C lower limit of normal \\[LLN\\]; magnesium \\\u003C LLN; calcium \\\u003C LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause torsades de pointes",{"count":404,"type":21},300,[55],"This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.",[408,409,410,411,412],"Advanced Lung Non-Squamous Non-Small Cell Carcinoma","Metastatic Lung Non-Squamous Non-Small Cell Carcinoma","Recurrent Lung Non-Squamous Non-Small Cell Carcinoma","Stage IIIB Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8",{"date":34,"type":35},{"date":415,"type":35},"2020-12-28",{"date":417,"type":21},"2026-12-31",{"name":41,"class":42},603,{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":429,"conditions":430,"keywords":432,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":438,"leadSponsor":440,"locationsCount":99},"100053552","experience-and-management-of-cancer-screening-related-anxiety-in-fanconi-anemia-100053552","NCT06744283","Experience and Management of Cancer Screening-Related Anxiety in Fanconi Anemia","The Experience and Management of Cancer Screening-Related Anxiety in Fanconi Anemia: an Ethnographic Study","* INCLUSION CRITERIA:\n\nParticipants enrolled in the FACSS protocol who are 18 years of age or older are eligible for inclusion in this study. Clinical visits eligible for ethnographic observation are limited to initial visits (medical history and physical examination) and\u002For return of results visits happening in the context of their first visit to the NIH Clinical Center for the FACSS protocol and\u002For annual return visits.\n\nTo be eligible, the following requirements must be met:\n\n* Ability for the participant to speak, read, and\u002For write in English to understand and agree to a verbal consent.\n* Participants must have a diagnosis of FA.\n* Participants must be 18 years of age or older.\n\nEXCLUSION CRITERIA:\n\n* Individuals who do not meet eligibility criteria.\n* Subjects who declined or opted out of allowing their data to be used for future research.\n* Subjects who orally declined to have Dr. Emily Pearce shadow their clinical center visits.\n* No other exclusionary criteria apply.","100 Years",{"count":131,"type":21},"Background:\n\nFanconi anemia (FA) is a rare, inherited cancer syndrome. FA causes a range of physical issues. Children with FA may have abnormal features; these may include a small head and eyes and issues with their internal organs. Young adults have a much higher risk of cancer. To screen for these cancers, people with FA may need to pursue many visits with different doctors. This constant need for cancer screening may cause anxiety for people with FA.\n\nObjective:\n\nTo learn more about anxiety related to cancer screenings in people with FA.\n\nEligibility:\n\nAdults aged 18 years and older with FA. They must also be enrolled in FACSS. FACSS is a study that screens people with FA for cancer every year.\n\nDesign:\n\nAll data gathered for this study will occur during routine FACSS visits. No other visits are needed.\n\nAn observer will be in the room during participants FACSS visits. The observer and participant will have a polite introduction. After that, the observer will not interact with participants in any way.\n\nThe observer will note details about the participants, such as:\n\n* Body language.\n* Worries about screening.\n* Comments that suggest anxiety or depression.\n* Clinical environment, such as d(SqrRoot)(Copyright)cor and temperature.\n* Accessibility issues. These can include lights and noises as well as ease of traveling around the clinic center.\n* Evidence of social support, such as engaging in the FA community.\n* Challenges they ve had in FACSS.\n* Their motivation to participate in FACSS.\n* Relationship dynamics among clinic staff, participants, and their care partners.\n\nData will also be collected from FACSS visit notes dating back to December 2024 and from participants medical records.",[431],"Fanconi Anemia",[433,431,434,435],"Uncertainty","Cancer","Screening",{"date":34,"type":35},{"date":95,"type":21},{"date":439,"type":21},"2027-01-30",{"name":41,"class":42},{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":448,"minAge":18,"maxAge":75,"enrollmentInfo":449,"targetDuration":4,"studyType":22,"phases":451,"briefSummary":452,"conditions":453,"keywords":456,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":463,"leadSponsor":465,"locationsCount":99},"100053341","phase-2-il-15-superagonist-with-or-without-vaccine-in-biochemically-recurrent-prostate-cancer-after-previous-stereotactic-body-radiation-therapy-100053341","NCT07686380","IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy","Phase II Trial of IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy","* INCLUSION CRITERIA:\n* Histopathological confirmation of prostate adenocarcinoma by the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center prior to the study treatment initiation. If no pathologic specimen is available, participants may enroll with a pathologist s report showing a histologic diagnosis of prostate adenocarcinoma and a clinical course consistent with the disease from any outside site.\n* Biochemically recurrent prostate cancer, defined as PSA over 0.8 ng\u002Fml following radical prostatectomy or \\>= 2 ng\u002Fml above the nadir following definitive radiotherapy or definitive radiotherapy (including brachytherapy) for localized prostate cancer.\n* Participants must be at least 1 year removed from definitive local therapy before the study treatment initiation.\n* Recovery to baseline from acute toxicity related to prior therapy, including surgery and radiation.\n* Hepatic function eligibility parameters: Bilirubin (total and direct) \\\u003C= upper limit of normal (ULN) (OR in participants with Gilbert s syndrome, a total bilirubin \\\u003C= 3.0), aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C= 1.5 times upper limit of normal.\n* Adequate renal function defined by a calculated creatinine clearance \\> 50 mL\u002Fmin according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24-hour urine collection.\n* ECOG performance score 0-1.\n* No other active malignancies within the 36 months prior to the study treatment initiation (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder).\n* 18 years of age or older.\n* Individuals must agree to use effective contraception (barrier, vasectomy and\u002For abstinence) for the duration of study therapy and for four months after the last treatment administration. Individuals with partners with birthing potential will be recommended that their partner use a highly effective contraception (includes use of oral, injected or implanted hormonal methods of contraception, placement of certain intrauterine devices (IUD) or intrauterine systems (IUS), hysterectomy, oophorectomy, salpingectomy.\n* Individuals must agree to not donate sperm during the restricted period (for the duration of study therapy and for four months after the last dose of study treatment).\n* Negative CT scan\u002F Magnetic resonance imaging (MRI) for evidence of soft tissue metastasis (visceral or lymph node).\n* Negative Tc99 for evidence of bone disease.\n* Participants must have had prior SBRT to PSMA+ findings beyond the prostate and have had a documented 25% or more PSA rise from post-SBRT nadir\n* Baseline testosterone \\>= 100 ng\u002Fdl.\n* Hematological parameters:\n\n  * Granulocyte count \\>= 1000\u002Fmm\\^3\n  * Platelet count \\>= 100000\u002Fmm\\^3\n  * Hemoglobin (Hgb) \\>= 10 g\u002FdL\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Immunocompromised status due to:\n\n  * Human immunodeficiency virus (HIV) seropositivity\n  * HBV or HCV seropositivity\n  * Other immunodeficiency diseases\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed. Participants with diabetes type I, vitiligo, or alopecia are allowed.\n* Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).\n* Chronic administration (defined as daily or every other day for continued use \\> 14 days) of systemic corticosteroids within 28 days before the study treatment initiation. Note: Use of corticosteroids with minimal systemic absorption (e.g., inhaled steroids, nasal sprays, and topical agents) is allowed.\n* Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 28 days prior to the study treatment initiation.\n* Major surgery within 28 days prior to study treatment initiation.\n* Systemic therapy, including any investigational therapy within 28 days prior to the study treatment initiation.\n* Radiation therapy within 14 days prior to the study treatment initiation.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.\n* Clinically significant cardiovascular\u002Fcerebrovascular disease as follows: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to the first planned dose of study drugs), myocardial infarction (\\\u003C 6 months prior to the first planned dose of study drugs), or any of the following at time of enrollment: unstable angina, congestive heart failure (New York Heart Association Classification Class \\>= II), serious cardiac arrhythmia, or uncontrolled hypertension (SBP\\>170\u002F DBP\\>105).\n* Serious intercurrent medical illness evaluated by medical history and physical exam that would interfere with participant's ability to carry out the treatment program.","MALE",{"count":450,"type":21},65,[24],"Background:\n\nBiochemically recurrent prostate cancer (BCR) occurs when prostate-specific antigen (PSA) levels in the blood rise after surgery or radiation. BCR affects 30,000 to 50,000 men each year. Researchers want to know if a drug (N-803) alone or combined with a vaccine (ETBX-071) can reduce PSA in BCR prostate cancer after radiation.\n\nObjective:\n\nTo test a study drug alone and combined with a vaccine in people with BCR prostate cancer who have been treated with targeted radiation to areas of recurrent prostate cancer in the past.\n\nEligibility:\n\nPeople aged 18 years and older with BCR prostate cancer who have previously undergone treatment with stereotactic body radiation therapy (SBRT).\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and kidney function. They will have 3 different imaging scans of their tumors.\n\nN-803 is injected under the skin of the abdomen. ETBX-071 is injected under the skin of thigh.\n\nParticipants will be divided into 2 groups: 1 group will get N-803 alone; 1 group will get both N-803 and ETBX-071.\n\nThe drug or drugs will be given on the first day of 21-day treatment cycles. Participants will have 8 treatment cycles.\n\nParticipants will have a follow-up visit 3 weeks after their last dose of the study drugs. Blood tests and all 3 imaging scans will be repeated.\n\nFollow-up visits will continue every 4 to 8 weeks for 5 years. These visits will include a positron emission tomography (PET) scan every 6 months.",[454,455],"Recurrent Prostate Cancer","Prostate Cancer",[454,457,458,459,460],"IL-15 Superagonist","N-803","ETBX-071","PSA Vaccine",{"date":34,"type":35},{"date":95,"type":21},{"date":464,"type":21},"2029-01-30",{"name":41,"class":42},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":448,"minAge":18,"maxAge":75,"enrollmentInfo":473,"targetDuration":4,"studyType":22,"phases":475,"briefSummary":476,"conditions":477,"keywords":483,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":487,"leadSponsor":489,"locationsCount":99},"100053608","phase-2-multitargeted-recombinant-ad5-psamuc-1brachyury-based-immunotherapy-triadeno-vaccine-with-il-15-superagonist-n-803-in-participants-with-clinically-localized-prostate-cancer-undergoing-active-surveillance-100053608","NCT07574541","Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","Phase II Trial of a Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","* INCLUSION CRITERIA:\n* Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist.\n* Participants must be on active surveillance.\n* Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \\[FFPE\\] biopsy core or one H and E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation.\n* Serum PSA level of \\\u003C20 ng\u002FmL (or \\\u003C10ng\u002FmL for participants being treated with 5- alpha-reductase inhibitors)\n* Clinical stage \\\u003C=T2a by digital rectal exam (DRE)\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1.\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1.0 x 109\u002FL\n  * Hemoglobin (Hgb) \\>=9 g\u002FdL\n  * Platelets \\>=75,000\u002FmcL\n  * Prothrombin International Normalized Ratio (INR) \\\u003C1.5 x upper limit of normal (ULN)\n  * Partial thromboplastin time (PTT) \\\u003C1.5 x ULN\n  * Total bilirubin \\\u003C1.5 x ULN\n  * Aspartate aminotransferase (AST) \\\u003C=2.5 x ULN\n  * Alanine aminotransferase (ALT) \\\u003C=2.5 x ULN\n  * Creatinine \\\u003C=1.5 x ULN\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n* Treatment with steroid therapy must have a washout of at least 6 weeks prior to initiation of study treatment. Physiologic (replacement) doses of steroids as well as nasal, topical, or inhaled steroids are allowed.\n* Vaccination with a live (attenuated) vaccine (e.g., FluMist(R)) or a killed (inactivated)\u002Fsubunit vaccine (e.g., PNEUMOVAX(R), Fluzone(R)) must occur not sooner than 28 days or 14 days, respectively, prior to initiation of study treatment.\n* Participants must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to one (1) month after the last vaccine injection. We also will recommend participants with female partners of childbearing potential to ask them to be on highly effective birth control (hormonal, intrauterine device \\[IUD\\], surgical sterilization). Participants must not freeze or donate sperm within the same period.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.\n* Evidence of PCa with metastatic disease.\n* Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.\n* Prior solid organ or bone marrow transplant.\n* Immunodeficiency or splenectomy.\n* Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology.\n* History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled.\n* History of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly\n\ncontrolled angina, or history (\\\u003C1 year prior to initiation of study therapy) of ventricular arrhythmia.\n\n* Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions.\n* Second malignancy within 3 years prior to initiation of study therapy. Note: Individuals with curatively treated non-melanoma skin cancers or non-muscle invasive bladder cancer will not be excluded.\n* History of herbal products that may decrease PSA levels (e.g., saw palmetto).\n* Participants who have undergone surgery within 4 weeks prior to initiation of study therapy.\n* Participants receiving any other investigational agents within 30 days prior to initiation of study therapy.\n* History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements suggested by medical history, physical examination, or standard clinical assessments such as imaging, EKG, and laboratory studies.",{"count":474,"type":21},52,[24],"Background:\n\nProstate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.\n\nObjective:\n\nTo test TriAdeno and N-803 in people with early-stage prostate cancer.\n\nEligibility:\n\nPeople aged 18 years and older with early-stage low- or medium-risk prostate cancer.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.\n\nTriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.\n\nParticipants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.\n\nBlood tests, imaging scans, and other tests will be repeated during the study.\n\nA tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.\n\nParticipants will have follow-up phone calls for 5 years....",[478,455,479,480,481,482],"Adenocarcinoma","Neoplasms","Carcinoma","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type",[484],"Immune Infiltration",{"date":34,"type":35},{"date":95,"type":21},{"date":488,"type":21},"2028-06-15",{"name":41,"class":42},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":498,"conditions":499,"keywords":504,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":99},"100053304","molecular-characterization-of-viral-associated-tumors-tumors-occurring-in-the-setting-of-hiv-or-other-immune-disorders-and-castleman-disease-100053304","NCT03300830","Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease","* INCLUSION CRITERIA:\n\nParticipants with one or more of the following:\n\n* HIV or other acquired immunodeficiency and cancer\n* Viral-associated cancer or cancer hypothesized to be caused by a virus\n* HIV-negative participants with cancer that commonly occurs in people with HIV\n\n  --KSHV-associated malignancy or related diseases, such as Multicentric Castleman Disease (MCD)\n* A malignancy hypothesized to be caused by an endogenous retrovirus\n* Idiopathic Castleman disease\n\nCancer diagnoses will be confirmed by the NCI Laboratory of Pathology (LP). A biopsy will be collected if sufficient archival tissue is not available.\n\n* Age \\>=18 years.\n* ECOG performance status \\\u003C=2 (Karnofsky \\>=60%) if biopsy to be performed is solely for the purposes of this protocol. Any ECOG performance status will be allowed if biopsy required for participant care or another NIH protocol that allows lower performance status or if enrollment on this protocol is only for the purposes of studying tissue that has already been collected.\n* Participants must have signed or be willing to sign an IRB-approved informed consent document that permits the use of the tumor and other samples for genomic-based molecular characterization projects. Telephone consent for use of archival tissue or tissue collected on another protocol or standard participant care will be permitted.\n* Co-enrollment on other HAMB, NCI, or NIH protocols is allowed\n\nEXCLUSION CRITERIA:\n\n* Inability to provide informed consent.\n* Pregnancy: Pregnant women will not be allowed to participate in this study because there is not a potential benefit.",{"count":497,"type":21},280,"Background:\n\nA person s genome is the collection of all their genes. A gene instructs individual cells to make proteins. Proteins are involved in all of our body s chemical processes. Genome sequencing allows researchers to find variations in genes. Some of these are normal and are not known to cause disease. Some variants are known to cause or affect diseases like cancer. Researchers want to study genetic variants in people with cancer who also have an immunologic disease like HIV.\n\nObjective:\n\nTo study the biology of cancer in order to improve ways to prevent, detect, and treat it.\n\nEligibility:\n\nAdults at least 18 years old with certain cancers and\u002For immunodeficiencies\n\nDesign:\n\nParticipants will be screened with medical history, physical exam, and lab tests.\n\nParticipants will give samples of one or more tissue type.\n\nThey may give blood or urine samples.\n\nResearchers may get samples of tissue when participants have surgery or when the participants are on other protocols in the NCI.\n\nParticipants may have a procedure to have tissue samples removed.\n\nResearchers may collect data from participant medical records.\n\nResearchers will compare the genes in a participant s cancer tissue to their normal tissue. They may use the tissue cells to grow new cells in a lab.\n\nParticipants may be contacted about the results.\n\nThe samples will be stored for future research. No personal data will be kept with them.\n\n...",[500,501,502,503],"Human Immunodeficiency Virus","Castleman's Disease","Kaposi's Sarcoma","Viral-Associated Cancer",[505,503,506,507,508,509],"Immunodeficiency","Kaposi Sarcoma Herpes Virus","Idiopathic Castleman Disease","Endogenous Retroviruses","Natural History",{"date":34,"type":35},{"date":512,"type":35},"2017-12-20",{"date":514,"type":21},"2037-06-25",{"name":41,"class":42},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":537},"100053688","phase-2-testing-the-addition-of-the-anti-cancer-drug-venetoclax-andor-the-anti-cancer-immunotherapy-blinatumomab-to-the-usual-chemotherapy-treatment-for-infants-with-newly-diagnosed-kmt2a-rearranged-or-kmt2a-non-rearranged-leukemia-100053688","NCT06317662","Testing the Addition of the Anti-cancer Drug Venetoclax and\u002For the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia","A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321\n* Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be \\> 36 weeks gestational age at the time of enrollment\n* Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization \\[WHO\\] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage\n\n  * Diagnostic immunophenotype: Leukemia cells must express CD19\n\nExclusion Criteria:\n\n* Patients with Down Syndrome\n* Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy\n* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of:\n\n  * Steroid pretreatment:\n\n    * PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility\n    * Inhaled and topical steroids are not considered pretreatment\n    * Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred \\> 28 days before enrollment does not affect eligibility\n  * Intrathecal cytarabine or methotrexate:\n\n    * An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility\n    * Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status\n  * Hydroxyurea:\n\n    * Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met","365 Days",{"count":525,"type":21},153,[24],"This phase II trial tests the addition of venetoclax and\u002For blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \\[R\\]) or without a KMT2A gene rearrangement (KMT2A-germline \\[G\\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and\u002For blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and\u002For blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.",[529,530],"Acute Leukemia of Ambiguous Lineage","B Acute Lymphoblastic Leukemia",{"date":34,"type":35},{"date":533,"type":35},"2025-06-05",{"date":535,"type":21},"2028-12-31",{"name":41,"class":42},113,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":22,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":559},"100054262","phase-2-testing-the-use-of-the-combination-of-selumetinib-and-olaparib-or-selumetinib-alone-targeted-treatment-for-ras-pathway-mutant-recurrent-or-persistent-ovarian-and-endometrial-cancers-a-combomatch-treatment-trial-100054262","NCT05554328","Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial","A Randomized Trial of Selumetinib and Olaparib or Selumetinib Alone in Patients With Recurrent or Persistent RAS Pathway Mutant Ovarian and Endometrial Cancers: A ComboMATCH Treatment Trial","Inclusion Criteria:\n\n* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N4 based on the presence of an actionable mutation as defined in EAY191\n* Patients must be enrolled on the ComboMATCH Master Registration Trial EAY191\n* Patients must have RAS pathway mutations as determined by the ComboMATCH screening assessment\n\n  * Cohort 1: Patients with histologically confirmed RAS pathway mutant ovarian, primary peritoneal, or fallopian tube (\"ovarian\") cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1)\n  * Cohort 2: Patients with histologically confirmed RAS pathway mutant endometrial cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1)\n* Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)\n* Patients must have progressed after first-line treatment for recurrent or persistent disease\n* Patients with ovarian cancer should not be eligible for further platinum-based therapy\n* Patients with endometrial cancer must have received or been offered an immune oncology agent (alone or in combination with lenvatinib) unless there are existing contraindications for immune oncology agents or lenvatinib\n* Patients may have received unlimited prior therapy\n* Patients must have measurable and biopsiable disease. Measurable disease is defined by RECIST 1.1 as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \\> 10 mm when measured by CT, magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \\> 20 mm when measured by chest x-ray. Lymph nodes must be \\> 15 mm in short axis when measured by CT or MRI\n\n  * Patients must have at least one \"target lesion\" separate from the lesion to be biopsied to be used to assess response on this protocol as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy\n* Prior therapy must have been completed at least four weeks prior to registration\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2\n* Hemoglobin (Hgb) \\>= 9.5 g\u002FdL with no blood transfusion in the past 28 days (within 14 days prior to registration)\n* Platelets \\>= 100,000\u002Fmcl (within 14 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmcl (within 14 days prior to registration)\n* Patients must have creatinine clearance estimated of \\>= 50 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test (within 14 days prior to registration)\n* Total bilirubin level =\\\u003C 1.5 x institutional upper limit of normal (ULN) or =\\\u003C 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) (within 14 days prior to registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x ULN (within 14 days prior to registration)\n* Patients must be able to swallow and retain oral medications and be without gastrointestinal illnesses that would preclude absorption of selumetinib or olaparib\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Women of childbearing potential (WOCBP) must agree to use two forms of birth control (hormonal or barrier method of birth control; abstinence) during the study and for 6 months after completing treatment\n\n  * Non-sterilized male partners of WOCBP (including males sterilized by a method other than bilateral orchidectomy e.g., vasectomy) who intend to be sexually active with a female partner must be using an acceptable method of contraception such as male condom plus spermicide (condom alone in countries where spermicides are not approved) from the time of screening throughout the total duration of the study and the drug washout period (at least 6 months after the last dose of study intervention) to prevent pregnancy in a partner. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Vasectomized (i.e., sterile) males are considered fertile and should still use a male condom plus spermicide as indicated above during the clinical study\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial\n* Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated\n\n  * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy\n\n  * Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression\n  * Extra caution should be taken with olaparib, as it crosses the blood brain barrier and can cause edema in brain metastases\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information\n\nExclusion Criteria:\n\n* Patients who have received any MEK inhibitors\n* Patients who have progressed while receiving a PARP inhibitor\n* Patients who have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients with uncontrolled intercurrent illness\n* Patients with \\>= grade 2 neuropathy within 14 days of registration\n* Patients with severe (Child-Pugh C) liver dysfunction\n* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib and selumetinib or any excipients thereof\n* Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents\n\n  * Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E\n  * Vitamin E must not be taken in the 7 days prior to initiation of treatment with selumetinib\n* Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or known moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, Fluconazole, verapamil). The required washout period prior to starting olaparib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication\n* Concomitant use of strong CYP2C19 inhibitors (e.g., ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole). The required washout period prior to starting selumetinib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication\n* Have received or are receiving an investigational medicinal product (IMP) or other systemic anti-cancer treatment (including chemotherapy, immunotherapy, targeted therapy, biologic therapy, tumor embolization, or monoclonal antibodies) within 4 weeks prior to registration, or within a period during which the IMP or systemic target treatment has not been cleared from the body (e.g., a period of 5 'half-lives'), whichever is longer\n* Known myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML)\n* Patients who have had previous organ transplant, allogenic bone marrow transplant or double umbilical cord blood transplantation\n* Patients who have had whole blood transfusion within 28 days prior to registration\n* Patients with ophthalmological conditions as follows:\n\n  * Current or past history of retinal pigment epithelial detachment\u002Fcentral serous retinopathy or retinal vein occlusion.\n  * Intraocular pressure \\> 21 mmHg (or ULN adjusted by age) or uncontrolled glaucoma (irrespective of intraocular pressure \\[IOP\\]). Subjects with known glaucoma and increased IOP who do not have meaningful vision (light perception only or no light perception) and are not experiencing pain related to the glaucoma, may be eligible after discussion with the study chair\n  * Patients with any other significant abnormality on ophthalmic examination should be discussed with the study chair for potential eligibility\n  * Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN) (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study\n* Patients with severe, active co-morbidity defined as any of the following:\n\n  * History and\u002For confirmed pneumonitis\n  * Uncontrolled hypertension (blood pressure \\[BP\\] \\>= 150\u002F90 mmHg despite medical therapy)\n  * Acute coronary syndrome within 6 months prior to registration\n  * Uncontrolled atrial fibrillation\n  * Known family history of long QT syndrome\n* Women who are pregnant or unwilling to discontinue nursing",{"count":546,"type":21},165,[24],"This phase II ComboMATCH treatment trial compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of olaparib to selumetinib could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to selumetinib alone.",[59,550,551,552],"Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma",{"date":34,"type":35},{"date":555,"type":35},"2023-04-25",{"date":557,"type":21},"2028-10-01",{"name":41,"class":42},296,{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":567,"enrollmentInfo":568,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":580,"locationsCount":581},"100053484","phase-2-a-study-using-nivolumab-in-combination-with-chemotherapy-drugs-to-treat-nasopharyngeal-carcinoma-npc-100053484","NCT06064097","A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)","A Phase 2 Study Using Chemoimmunotherapy With Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)","Inclusion Criteria:\n\n* Patients must be ≤ 21 years of age at the time of study enrollment\n* Newly diagnosed American Joint Committee on Cancer (AJCC) stage II-IV nasopharyngeal carcinoma (NPC)\n\n  * Patients must have had histologic verification of the malignancy at original diagnosis\n  * Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended\n* Patients must have had histologic verification of the malignancy at original diagnosis\n* Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended\n* Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for patients \\> 16 years of age) performance status score of ≥ 60%\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002FuL (within 7 days prior to start of protocol therapy)\n* Platelet count ≥ 100,000\u002FuL (transfusion independent) (within 7 days prior to start of protocol therapy)\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 or (within 7 days prior to start of protocol therapy)\n* A serum creatinine based on age\u002Fsex (within 7 days prior to start of protocol therapy) Age: Maximum serum creatinine (mg\u002FdL)\n\n  1 month to \\\u003C 6 months: 0.4 mg\u002FdL (male); 0.4 mg\u002FdL (female) 6 months to \\\u003C 1 year: 0.5 mg\u002FdL (male); 0.5 mg\u002FdL (female)\n\n  1 to \\\u003C 2 years: 0.6 mg\u002FdL (male); 0.6 mg\u002FdL (female) 2 to \\\u003C 6 years: 0.8 mg\u002FdL (male); 0.8 mg\u002FdL (female) 6 to \\\u003C 10 years 1 mg\u002FdL (male); 1 mg\u002FdL (female) 10 to \\\u003C13 years: 1.2 mg\u002FdL (male); 1.2 mg\u002FdL (female) 13 to \\\u003C 16 years: 1.5 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n\n  ≥ 16 years: 1.7 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and (within 7 days prior to start of protocol therapy)\n* Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) ≤ 135 U\u002FL\\* (within 7 days prior to start of protocol therapy)\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* Shortening fraction of ≥ 27% by echocardiogram, or\n* Ejection fraction of ≥ 50% by radionuclide angiogram\n* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and T-cell count above the lower limit of normal are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n\nExclusion Criteria:\n\n* Patients who received prior radiotherapy to the head or neck\n* Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission\n* Patients with a diagnosis of immunodeficiency\n* Patients with an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive agents). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n\n  * Note: Patients with well-controlled asthma and no need for systemic steroids for the treatment of asthma in the last 12 months will not be excluded\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 0.25 mg\u002Fkg (10 mg) daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 0.25 mg\u002Fkg (10 mg) daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Patients with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n* Patients with detectable viral load of human immunodeficiency virus (HIV), hepatitis B or hepatitis C, or active tuberculosis\n* Patients who have undergone solid organ or allogeneic hematopoietic transplant at any time\n* Due to risks of fetal and teratogenic adverse events as seen in animal studies, a negative pregnancy test must be obtained in females of childbearing potential, defined as females who are post-menarchal. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Females of childbearing potential that are sexually active must agree to either practice 2 medically accepted highly-effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 5 months after the last dose of nivolumab, 6 months after the last dose of gemcitabine, and 14 months after the last dose of cisplatin, whichever is longer\n* Males of childbearing potential that are sexually active must agree to either practice a medically accepted highly-effective methods of contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 3 months after the last dose of gemcitabine, and 11 months after the last dose of cisplatin, whichever is longer\n* Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy through 5 months after the last dose of nivolumab\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","21 Years",{"count":569,"type":21},50,[24],"This phase II trial tests effects of nivolumab in combination with chemotherapy drugs prior to radiation therapy patients with nasopharyngeal carcinoma (NPC). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and\u002For bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.",[573,574,575],"Stage II Nasopharyngeal Carcinoma AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage IV Nasopharyngeal Carcinoma AJCC v8",{"date":34,"type":35},{"date":578,"type":35},"2024-06-25",{"date":417,"type":21},{"name":41,"class":42},85,{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":599,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":612,"leadSponsor":614,"locationsCount":99},"100053779","phase-1-study-of-preoperative-radiation-therapy-in-participants-with-resectable-recurrent-abdominal-adrenocortical-carcinoma-100053779","NCT06487481","Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma","A Phase I Dose-escalation Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma","* INCLUSION CRITERIA:\n* Age \\>= 18 years\n* Pathological confirmation of ACC by the Laboratory of Pathology, NCI. Note: Confirmation may be done from archival sample; fresh tissue is not required unless otherwise acquired for clinical purposes.\n* Measurable disease by RECISTv1.1. criteria at enrollment\n* Evidence of recurrent ACC amenable to surgical resection that can be performed at NIH Clinical Center (CC)\n* Must be suitable for external beam radiotherapy AND surgery in the opinion of the treating investigator (e.g., based on clinical history and imaging)\n* Participants with metastatic ACC outside the area(s) to be exposed to investigational treatments (e.g., liver parenchyma, lung\\[s\\], or bone\\[s\\]) must have disease that is amendable for a complete resection and\u002For catheter-based and\u002For radiation-based ablation.\n* Mitotane therapy- Participants may be receiving mitotane currently, have received it in the past, or never have received mitotane. However, participants will be evaluated in separate cohorts based on mitotane use and, as enrollment is sequential, not all participants may be eligible for the study at all times. Note: Participants with a history of mitotane use may continue on study at the discretion of the treating investigator. Participants will not initiate mitotane on study.\n* Participants must agree to undergo tumor biopsy of easily accessible tumor sites prior to study treatment.\n* Performance Status (ECOG) 0-2\n* Adequate organ function, including:\n\n  * Hemoglobin \\>= 9.0 gm\u002FdL\n  * ANC \\>= 1,500\u002Fmm\\^3\n  * Platelets \\>= 75,000\u002Fmm\\^3\n  * AST and ALT \\\u003C= 3 x Upper Limit Normal (ULN)\n  * Bilirubin \\\u003C= 2 x ULN\n  * Creatinine within normal institutional limits or creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal calculated using eGFR.\n* Individuals of childbearing potential must agree to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) prior to RT and continue until at least 4 months following cytoreduction surgery.\n* Nursing (including breastfeeding) participants must agree to discontinue nursing prior to RT and continue until at least 4 months following cytoreductive surgery.\n* Ability of participant to understand and willingness to sign a written informed consent document\n* Participants must agree to co-enroll in tissue collection protocol 09C0242 \"Prospective comprehensive molecular analysis of endocrine neoplasms.\"\n\nEXCLUSION CRITERIA:\n\n* Primary ACC or suspicious\u002Findeterminate adrenal tumor without pathological confirmation\n* Prior abdominal radiation therapy\n* Participants who have received chemotherapy, immunotherapy, investigational therapy, or radiotherapy treatment within the last 4 weeks prior to starting treatment and\u002For have not recovered from toxicities to less than grade 2 CTCAE.\n* Infection requiring parenteral antibiotics\n* Suspected or proven ACC peritoneal metastasis\n* Pre-existing known or suspected radiation sensitivity syndromes\n* Prohibitive condition(s) to diagnostic laparoscopy\n* Participants who have an unacceptable risk for a major surgical procedure such as participants with high risks for major cerebro-cardiovascular (such as those who had doxorubicin exposure as based on screening echocardiogram and ECG) and pulmonary complications and those with estimated perioperative mortality greater than 15% per ACS NSQIP Surgical Risk calculator.\n* Participants receiving other investigational therapies\n* Participant pregnancy\n* Active systemic infections, coagulation disorders, or other major medical illnesses such as uncontrolled diabetes mellitus, uncontrolled hypertension (persistently grade 2 or worse), active severe cerebro-cardio-pulmonary diseases, and acute major organ dysfunction.\n* Acute intraabdominal conditions such as obstruction or peritonitis at the time of the evaluation or surgery.\n* Evidence at screening of or currently active CNS metastasis within 6 months of RT; participants with history of treated brain metastases with intracranial recurrence within 6 months prior to treatment. Note: Participants with any signs or symptoms suggestive of previously undiagnosed brain metastasis at screening or with a history of brain metastasis should receive imaging at screening; otherwise, imaging is not required.\n* HIV-positive participants with CD4 below 200 or who are not on anti-retroviral therapy\n* Participants who have a history of another primary malignancy from which the participant has been disease-free for \\\u003C 3 years at the time of enrollment.",{"count":590,"type":21},32,[79],"Background:\n\nAdrenocortical carcinoma (ACC) is a rare cancer of the adrenal glands. ACC often returns after tumors are removed with surgery. Less than 35% of people with ACC survive 5 years after diagnosis.\n\nObjective:\n\nTo test a new type of external beam RT before surgery in people with ACC.\n\nEligibility:\n\nPeople aged 18 years and older with ACC that came back after treatment but may be safely removed with surgery.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have tests of their heart function. They will have imaging scans. A small sample of tumor tissue may be collected if one is not available. They will undergo laparoscopy: Small incisions will be made in the abdomen so that a thin tube with a light and camera can be inserted to view the organs.\n\nRT comes from a machine that aims radiation at tumors. Participants will receive preoperative RT in daily fractions over approximately 2-3 weeks, followed by a planned surgical resection about 4 weeks after the completion of RT. Visits will last 30 to 60 minutes.\n\nParticipants will undergo surgery to remove their tumors about 4 weeks after they finish RT. They will stay in the hospital 1 to 3 weeks after surgery.\n\nParticipants will have follow-up visits for 10 years after surgery.",[594,595,596,597,598],"Adrenocortical Carcinoma (ACC)","Recurrent Adrenocortical Carcinoma (ACC)","Recurrent Abdominal Adrenocortical Carcinoma (ACC)","Carcinoma, Adrenocortical","Carcinoma, Adrenal Cortical",[600,601,602,603,604,605,606,607,608,609],"external beam radiation therapy (EBRT)","abdominal adrenocortical carcinoma (ACC)","preoperative radiation","Mitotane","Maximum Tolerated Dose (MTD)","Surgical Resection","in-field intraabdominal progression-free survival (PFS)","out-of-field intraabdominal progression-free survival (PFS)","DNA damage repair markers","oxidative stress response",{"date":34,"type":35},{"date":95,"type":21},{"date":613,"type":21},"2040-12-01",{"name":41,"class":42},{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":622,"maxAge":623,"enrollmentInfo":624,"targetDuration":4,"studyType":22,"phases":626,"briefSummary":627,"conditions":628,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":635},"100054157","phase-2-a-study-testing-the-combination-of-dasatinib-or-imatinib-to-chemotherapy-treatment-with-blinatumomab-for-children-adolescents-and-young-adults-with-philadelphia-chromosome-positive-ph-or-abl-class-philadelphia-chromosome-like-ph-like-b-cell-acute-lymphoblastic-leukemia-b-all-100054157","NCT06124157","A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)","An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Patients must be \\> 365 days and \\\u003C 18 years (for AIEOP-BFM), \\> 365 days and \\\u003C 22 years (for Children's Oncology Group \\[COG\\]) and \\> 365 days and \\\u003C 46 years (for ALLTogether sites) at the time of enrollment\n* Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and\u002For dasatinib: ABL1, ABL2, CSF1R, and PDGFRB\n* Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should be documented by a clinically-validated assay and enrolled on study by day 1 of Blinatumomab Block 1. Accepted methods of detection include fluorescence in situ hybridization (FISH) using break-apart of colocalization signal probes, singleplex or multiplex reverse-transcription polymerase chain reaction (RT-PCR), whole-transcriptome or panel-based ribonucleic acid (RNA) sequencing (e.g., Hematologic Cancer Fusion Analysis, TruSight RNA Pan-Cancer Panel or equivalent). Confirmation of 5' fusion partner genes is not required for study enrollment\n* Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and\u002For other standard cytotoxic chemotherapy\n* Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine\n* Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)\n* Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise indicated):\n\n  * Estimated GFR (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m2\n  * Measured GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard\n* For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL\u002Fmin, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on body weight\n* Direct bilirubin \\\u003C 2.0 mg\u002FdL (34.2 micromoles\u002FL) (must be performed within 7 days prior to enrollment unless otherwise indicated)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated)\n* \\* Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]) OR\n\n  * Left Ventricular Ejection fraction of ≥ 50% by radionuclide angiogram or echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]) AND\n  * Corrected QT Interval, QTc \\\u003C 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\])\n\n    * Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment\n\nExclusion Criteria:\n\n* Known history of chronic myeloid leukemia (CML)\n* ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase\n* ALL developing after a previous cancer treated with cytotoxic chemotherapy\n* Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation\n* Down syndrome (trisomy 21)\n* Pregnancy and breast feeding\n\n  * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment\n  * Lactating females who plan to breastfeed their infants\n  * Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol\n\n    * NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib dose or per institutional standard of care for multiagent chemotherapy, whichever is longer\n* Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib\n* Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block\n* Patients with known Charcot-Marie-Tooth disease\n* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS) involvement\n\n  * Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage remain eligible provided all neurologic deficits have resolved\n* HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","366 Days","46 Years",{"count":625,"type":21},222,[24],"This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes\u002Fcells\u002Fmolecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.",[530],{"date":34,"type":35},{"date":631,"type":35},"2025-05-30",{"date":633,"type":21},"2030-12-01",{"name":41,"class":42},154,""]