[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"interventionName\":\"Radiation Therapy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":588},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,122,0,25,[9,44,65,88,110,147,169,181,190,200,209,243,267,297,307,329,355,381,411,437,458,481,503,530,558],{"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},"100053397","phase-2-testing-the-addition-of-cemiplimab-regn2810-to-chemotherapy-treatment-given-prior-to-surgery-in-patients-with-sinonasal-squamous-cell-carcinoma-100053397",false,"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","ALL","18 Years",{"count":20,"type":21},108,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27,28,29,30],"Sinonasal Squamous Cell Carcinoma","Stage III Sinonasal Cancer AJCC v8","Stage IVA Sinonasal Cancer AJCC v8","Stage IVB Sinonasal Cancer AJCC v8","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":21},"2026-11-24",{"date":39,"type":21},"2030-12-16",{"name":41,"class":42},"National Cancer Institute (NCI)","NIH",5,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"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":52,"type":21},138,[24,54],"PHASE3","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.",[57],"Extensive Stage Lung Small Cell Carcinoma",{"date":34,"type":35},{"date":60,"type":35},"2021-01-07",{"date":62,"type":21},"2027-04-30",{"name":41,"class":42},416,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"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":74,"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.",[78,79,80],"Stage II Nasopharyngeal Carcinoma AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage IV Nasopharyngeal Carcinoma AJCC v8",{"date":34,"type":35},{"date":83,"type":35},"2024-06-25",{"date":85,"type":21},"2026-12-31",{"name":41,"class":42},85,{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":17,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"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":98,"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.",[102],"B Acute Lymphoblastic Leukemia",{"date":34,"type":35},{"date":105,"type":35},"2025-05-30",{"date":107,"type":21},"2030-12-01",{"name":41,"class":42},154,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100053977","phase-2-testing-the-addition-of-chemotherapy-or-chemo-immunotherapy-to-the-usual-surgery-for-advanced-head-and-neck-cancer-100053977","NCT07195734","Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer","A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients With Recurrent\u002FPersistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx\n* PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory\n* Verify insurance (or other payment) coverage for neoadjuvant chemotherapy\n* Measurable disease as defined by RECIST 1.1\n* Patients must have locally recurrent or persistent SCCHN arising within the oral cavity, oropharynx, larynx, or hypopharynx (American Joint Committee on Cancer \\[AJCC\\] Cancer Staging Manual, 8th Edition) AND are deemed candidates for salvage surgery:\n\n  * P16 positive oropharynx patients with T2, T3, T4, N0, N1, N2 and all other patients with T2, T3, T4a, N0, N1, N2a, N2b, N2c, N3a are eligible.\n  * Patients must be deemed surgically resectable without gross residual disease.\n  * For patients with oral cavity SCCHN, only those with recurrent or persistent disease after prior surgery are eligible.\n  * Patients who are candidates for salvage laryngectomy to treat recurrent laryngeal cancer and who are having salvage surgery for curative intent are eligible.\n  * Patients with resectable lymph node-only recurrence are eligible.\n  * No major vascular involvement (\\> 180° involvement of the common carotid or internal carotid artery), jugular foramen involvement, or prevertebral, paraspinous muscle involvement precluding a curative resection\n* No evidence of distant metastatic disease\n* The following minimum diagnostic workup is required:\n\n  * General history and physical examination.\n  * Diagnostic-quality neck CT and PET\u002FCT of neck (PET with attenuation-correction CT of neck, chest, and abdomen)\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 8.0 g\u002FdL (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] ≥ 8.0 g\u002FdL is acceptable)\n* Adequate renal function defined as creatinine clearance (CrCL) \\> 50 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Only patients who received prior radiation therapy in the definitive or post-operative setting (limited to one course) are eligible.\n\n  * Prior radiation therapy must have been completed at least 6 months prior to registration with the majority of the index persistent\u002Frecurrent cancer volume (\\> 50%) irradiated to ≥ 40 Gy at the time\n* Prior systemic therapy including immunotherapy with anti-PD1 or anti-PDL1 within the definitive setting (neo-adjuvant, or adjuvant) is permitted and must have been completed at least 4 months prior to registration\n* Prior systemic therapy including immunotherapy for treatment of recurrent or metastatic SCCHN is not permitted\n* No investigational anti-cancer agents received within 4 weeks prior to registration\n* No New York Heart Association Functional Classification III or IV (Note: 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)\n* No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments\n* No peripheral neuropathy grade 3 or 4\n* No history of interstitial lung disease\n* No active, noninfectious pneumonitis requiring immunosuppressive therapy\n* No history of a solid organ transplant (other than corneal transplant)\n* No active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease-modifying agents, corticosteroids \\[\\> 10 mg prednisone\u002Fday or equivalent\\] or immunosuppressive drugs)\n\n  * NOTE: Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll:\n\n    * Patients who require a brief course of steroids (e.g., prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded\n    * Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n    * Physiologic replacement doses ≤ 10 mg prednisone\u002Fday or equivalent are allowed. Inhaled or topical steroids are permitted\n* No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent, and immune checkpoint inhibitors (or any of its excipients)",{"count":118,"type":21},180,[24],"This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. 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 cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive 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 chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.",[122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139],"Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Locally Recurrent Head and Neck Squamous Cell Carcinoma","Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma","Locally Recurrent Laryngeal Squamous Cell Carcinoma","Locally Recurrent Oral Cavity Squamous Cell Carcinoma","Locally Recurrent Oropharyngeal Squamous Cell Carcinoma","Stage II Laryngeal Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Laryngeal Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8",{"date":34,"type":35},{"date":142,"type":35},"2026-04-24",{"date":144,"type":21},"2033-02-01",{"name":41,"class":42},92,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100053785","phase-3-dinutuximab-with-chemotherapy-surgery-and-stem-cell-transplantation-for-the-treatment-of-children-with-newly-diagnosed-high-risk-neuroblastoma-100053785","NCT06172296","Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma","A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma","Inclusion Criteria:\n\n* Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131\n* ≤ 30 years at the time of initial diagnosis with high-risk disease\n* \\* Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines\n\n  * Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:\n\n    * Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification\n    * Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)\n    * Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy\n    * Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)\n* Patients must have a body surface area (BSA) ≥ 0.25 m\\^2\n* No prior anti-cancer therapy except as outlined below:\n\n  * Patients initially recognized to have high-risk disease treated with topotecan\u002Fcyclophosphamide initiated on an emergent basis and within allowed timing, and with consent\n  * Patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease but subsequently found to meet the criteria\n  * Patients who received localized emergency radiation to sites of life threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis\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* A serum creatinine based on age\u002Fsex as follows:\n\n  * 1 month to \\\u003C 6 months: Male 0.4 mg\u002FdL and female 0.4mg\u002FdL\n  * 6 months to \\\u003C 1 year: Male 0.5 mg\u002FdL and female 0.5 mg\u002FdL\n  * 1 to \\\u003C 2 years: Male 0.6 mg\u002FdL and female 0.6 mg\u002FdL\n  * 2 to \\\u003C 6 years: Male 0.8 mg\u002FdL and female 0.8 mg\u002FdL\n  * 6 to \\\u003C 10 years: Male 1 mg\u002FdL and female 1 mg\u002FdL\n  * 10 to \\\u003C 13 years: Male 1.2 mg\u002FdL and female 1.2 mg\u002FdL\n  * 13 to \\\u003C 16 years: Male 1.5 mg\u002FdL and female 1.4 mg\u002FdL\n  * ≥ 16 years: Male 1.7 mg\u002FdL and female 1.4 mg\u002FdL\n\n    * The threshold creatinine values were derived from the Schwartz formula for estimating glomerular filtration rate (GFR) utilizing child length and stature data published by the Centers for Disease Control (CDC)\n  * or a 24-hour urine creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m\\^2 or\n  * or a 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\n    * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age\n* Serum glutamic pyruvic transaminase (SGPT) (Alanine aminotransferase \\[ALT\\]) ≤ 10 x ULN\\*\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\n  * Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram\n* Ability to tolerate Peripheral Blood Stem Cell (PBSC) collection:\n\nNo known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and\u002For the apheresis procedure\n\nExclusion Criteria:\n\n* Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features\n* Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features\n* Patients with known bone marrow failure syndromes\n* Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention\u002Ftreatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable\n* Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation\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","30 Years",{"count":156,"type":21},478,[54],"This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These 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. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.",[160,161],"Ganglioneuroblastoma, Nodular","Neuroblastoma",{"date":34,"type":35},{"date":164,"type":35},"2024-04-19",{"date":166,"type":21},"2029-12-31",{"name":41,"class":42},178,{"id":170,"slug":4,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":120,"conditions":173,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":178,"leadSponsor":179,"locationsCount":180},"100607990",{"count":118,"type":21},[24],[122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139],"2026-07-01",{"date":176,"type":35},"2026-07-02",{"date":142,"type":35},{"date":144,"type":21},{"name":41,"class":42},87,{"id":182,"slug":4,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":154,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":158,"conditions":185,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":188,"leadSponsor":189,"locationsCount":168},"100529324",{"count":156,"type":21},[54],[160,161],{"date":176,"type":35},{"date":164,"type":35},{"date":166,"type":21},{"name":41,"class":42},{"id":191,"slug":4,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":17,"minAge":95,"maxAge":96,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":100,"conditions":194,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":197,"leadSponsor":198,"locationsCount":199},"100525624",{"count":98,"type":21},[24],[102],{"date":176,"type":35},{"date":105,"type":35},{"date":107,"type":21},{"name":41,"class":42},153,{"id":201,"slug":4,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":55,"conditions":204,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":207,"leadSponsor":208,"locationsCount":64},"100393420",{"count":52,"type":21},[24,54],[57],{"date":176,"type":35},{"date":60,"type":35},{"date":62,"type":21},{"name":41,"class":42},{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":220,"conditions":221,"keywords":227,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":242},"100629759","phase-1-radiation-oral-vancomycin-and-car-t-for-b-cell-lymphomas-100629759","NCT07478848","Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas","A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy","Inclusion Criteria:\n\n* Male or female subject aged ≥ 18 years.\n* Pathologically confirmed B-cell lymphoma patients intended for standard of care CAR-T\n* ECOG Performance Status ≤ 2.\n* Subjects must be clinically eligible to receive standard of care anti-CD19 CAR-T\n* Subjects must have at least one site of disease amenable to radiation, with the ability to deliver radiation to at least 50% of involved sites\n* Subjects must have at least one site of measurable disease based on CT or FDG PET\n* Subjects must not be anticipated to require additional therapy beyond bridging radiation listed in this protocol for control of their lymphoma\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause.\n\nThe following age-specific requirements apply:\n\nWomen \\\u003C 50 years of age: amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n\nWomen ≥ 50 years of age: amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or had radiation-induced menopause with last menses \\>1 year ago; or had chemotherapy-induced menopause with last menses \\>1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Unable to take oral vancomycin for any reason, including: Allergy or Inability to swallow drug\n* Known history of vancomycin resistant enterococcus (VRE)\n* Contraindications to radiation therapy, including scleroderma, systemic lupus erythematosus, Crohn disease, ulcerative colitis, or idiopathic pulmonary fibrosis\n* History of radiation pneumonitis or other grade 4 radiation-related adverse event\n* Prior or concurrent malignancy whose natural history or treatment which has the potential to interfere with the safety or efficacy assessment of the radiation therapy are eligible for this trial.\n* Severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for standard-of-care CART therapy.\n* Known uncontrolled HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy or who will plan on going on antiretroviral therapy at the time of screening are eligible for this trial. HIV testing is not required for eligibility.\n* Active infection that required the use of antibiotics within 4 weeks prior to registration\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures",{"count":217,"type":21},14,[219],"PHASE1","This clinical trial assesses whether it is feasible to use radiation therapy with vancomycin prior to CAR T-cell therapy for patients with large B-cell lymphomas",[222,223,224,225,226],"Large B Cell Lymphoma","Non Hodgkin Lymphoma (NHL)","Diffuse Large B Cell Lymphoma (DLBCL)","Diffuse Large B Cell Lymphoma Refractory","Diffuse Large B Cell Lymphoma Relapsed",[228,229,230,231,232],"non-hodgkin lymphoma","NHL","large B cell lymphoma","DLBCL","diffuse large B cell lymphoma","2026-06-29",{"date":174,"type":35},{"date":236,"type":35},"2026-05-29",{"date":238,"type":21},"2029-01-01",{"name":240,"class":241},"Abramson Cancer Center at Penn Medicine","OTHER",1,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":266},"100411885","phase-2-total-neoadjuvant-therapy-with-mfolfox-and-short-course-radiation-in-resectable-rectal-cancer-100411885","NCT04643366","Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer","Phase 2 Study of Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer","Inclusion Criteria:\n\n* Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration. At least a portion of the tumor must be located below the peritoneal reflection or begin within 12 cm of the anal verge on flexible endoscopy\n* Clinically staged (AJCC 8th ed.) T3-4 N0 M0 or T any N1-2 M0 based upon the following minimum diagnostic workup:\n* Colonoscopy, unless patient presents with an obstructing lesion\n* Within 30 days before initiating MFOLFOX6 treatment:\n* History\u002Fphysical examination\n* Imaging to exclude distant metastases: either contrast-enhanced CT of the chest, abdomen, and pelvis; or whole-body PET-CT; or MRI\n* Pelvic MRI (preferred) or transrectal ultrasound (TRUS) for T staging Note: Patients may have initiated standard mFOLFOX6 treatment before study registration provided that they met the above criteria before initiating treatment and can feasibly continue to CRT according to the timeline described in Section\n* ECOG Performance Status ≤2\n* Age ≥ 18 years\n* Adequate bone marrow function defined as follows:\n* Absolute neutrophil count (ANC) ≥ 1,200 cells\u002Fmm3\n* Platelets ≥ 100,000 cells\u002Fmm3\n* Hemoglobin ≥ 8.0 g\u002FdL (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g\u002FdL is acceptable.)\n* Adequate liver and renal function defined as follows:\n* AST and alkaline phosphatase \\\u003C 2.5 x upper limit of normal (ULN)\n* Bilirubin ≤ 2.5 ULN\n* Calculated creatinine clearance (CrCl) \\> 30 mL\u002Fmin using Cockcroft-Gault formula as calculated by the standard Cockcroft-Gault equation using age, actual weight, creatinine, and gender\n* Must be deemed a candidate for curative resection by the surgical oncologist who will be performing the operation\n* Women of childbearing potential (WCBP) must have a negative serum pregnancy test performed within 7 days prior to the start of chemotherapy.\n* WCBP and men must agree to use a medically accepted form of birth control during the treatment and for 3 months following completion of chemotherapy.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior RT that would result in unsafe overlap of RT fields with the planned study treatment, per the treating radiation oncologist\n* Clinically significant cardiac disease, including major cardiac dysfunction, that in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.\n* Serious (ie, ≥ grade 3) uncontrolled infection\n* Pulmonary or respiratory condition that, in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.\n* Major surgery within 28 days of study enrollment (other than diverting colostomy)\n* History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis) requiring significant intervention (eg, hospitalization, surgery, immunosuppressive medications) that would, in the opinion of the investigator, preclude study therapy\n* Prior known allergic reaction to 5-fluorouracil, leucovorin, or oxaliplatin\n* Known dipyrimidine dehydrogenase deficiency (DPD)\n* Any evidence of distant metastases (M1)\n* Pregnant or breast feeding\n* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements",{"count":251,"type":21},64,[24],"This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.",[255],"Rectal Cancer",[257,258],"Resectable","Rectal",{"date":174,"type":35},{"date":261,"type":35},"2021-01-28",{"date":263,"type":21},"2032-01-31",{"name":265,"class":241},"Virginia Commonwealth University",4,{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":294,"locationsCount":296},"100449773","phase-1-papaverine-in-combination-with-chemoradiation-for-the-treatment-of-stage-ii-iii-non-small-cell-lung-cancer-100449773","NCT05136846","Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer","A Phase I Trial Targeting Mitochondrial Metabolism With Papaverine in Combination With Chemoradiation for Stage II-III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) =\\\u003C grade 1 (except alopecia) at the time of enrollment\n* Absolute neutrophil count \\>=1.5 x 10\\^9\u002FL\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelets \\>= 100 x 10\\^9\u002FL\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Creatinine \\\u003C 1.5 mg\u002FdL or calculated creatinine clearance\\* \\>= 50 mL\u002Fmin or 24-hour urine creatinine clearance \\>= 50 mL\u002Fmin\n\n  * Calculated by the Cockcroft-Gault formula •\\>= 18 years old\n* Non-small cell lung cancer (NSCLC), histologically and\u002For cytologically proven\n* Clinical American Joint Committee on Cancer (AJCC) stage II-III NSCLC (T1-4N0-3M0) and select patients with stage IV oligometastatic disease.\n\n  * For patients with oligometastatic disease (up to 5 total sites of disease) for whom definitive CRT or RT to the primary and regional lymph nodes is recommended by the multidisciplinary team, each individual metastatic tumor would be considered an additional site of disease with the exception of brain metastases. Up to 10 brain metastases would be considered as 1 site.\n  * Patients with oligometastatic disease will be allowed to receive adjuvant systemic therapy at the discretion of the medical oncologist and additional local therapy to metastatic sites at the discretion of the multidisciplinary team\n* Patients must be considered unresectable or medically-inoperable if stage II-III NSCLC\n\n  * Patients with a local or regional recurrence following surgical resection for whom definitive CRT or RT to disease in the chest is recommended by the multidisciplinary team will be considered eligible\n* Patients must have fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)-computed tomography (CT) scan (or CT chest\u002Fabdomen\u002Fpelvis with IV contrast), and magnetic resonance imaging (MRI) brain with IV contrast (preferred) or CT scan of the brain with contrast. Non-contrast MRI scans of the chest\u002Fabdomen\u002Fpelvis or brain are permitted for workup if patient has allergy to CT contrast or renal insufficiency\n* Patients must have vital signs, history\u002Fphysical examination, laboratory studies (complete blood count \\[CBCP\\] with differential, chemistries including liver function tests, creatinine clearance (CrCl) assessment; pregnancy test if needed within 14 days of registration)\n* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* No history of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), glaucoma, or priapism\n* Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed before starting treatment\n* Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed\n* Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of registration. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment\n* Nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from the treatment regimen\n* Women\u002Fmen of reproductive potential must be counselled on contraception\u002F abstinence while receiving the study treatment\n\n  * Women of childbearing potential are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the study duration, and until 6 months after the last dose of radiation. 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  * 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 for 6 months after completion of study drug administration\n* For patients planning to undergo CRT, patient is suitable to receive standard chemotherapy per treating medical oncologist with radiation during study treatment\n\nINCLUSION CRITERIA FOR MRI IMAGING SUB-STUDY:\n\n•Patients must consent to participate in the main part of this study and be enrolled into the expansion cohort, or consent to participate in the main part of this study and also consent to participate in the optional MRI Imaging study\n\nExclusion Criteria:\n\n* Patients with history of pneumonectomy\n* History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis\n* History of previous radiation therapy which would result in overlapping radiation fields\n* Subjects who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Hepatic insufficiency resulting in jaundice, or not meeting laboratory values above (albumin, total bilirubin, AST\u002FALT)\n* Patients enrolled into the expansion cohort must be able to complete the MRI Sub-study, or at a minimum attempt the first scan of the MRI Sub-study\n* Any serious and\u002For unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the treating physicians. This could include severe, active co-morbidities such as:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acquired immune deficiency syndrome (AIDS) based upon the current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n* Patients who are presently receiving nitrates or nitroglycerin, or have received these medications within 30 days of day 1 of protocol treatment\n* Patients who are currently taking Sildenafil should agree to discontinue use for 2 days prior to initiation of papaverine, during the duration of study, and for 2 days after last dose of papaverine\n\nEXCLUSION CRITERIA FOR MRI IMAGING SUB-STUDY:\n\n* Any medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, pregnancy, nursing mothers, weight greater than 350 pounds)\n* Severe anxiety\u002Fclaustrophobia related to MR imaging despite medications to relieve anxiety\u002Fclaustrophobia\n* Patients who use supplemental oxygen and are not able to stop their oxygen for up to a few hours at a time, or who use oxygen because they have breathing when they are laying down",{"count":275,"type":21},28,[219],"This phase I trial finds out the best dose, possible benefits and\u002For side effects of papaverine when given together with chemoradiation intreating patients with stage II-III non-small cell lung cancer. Papaverine targets mitochondrial metabolism to decrease the cancer growth process. Giving papaverine with chemoradiation may work best to treat patients with non-small cell lung cancer.",[279,280,281,282,283,284,285,286,287],"Locally Advanced Lung Non-Small Cell Carcinoma","Stage II Lung Cancer AJCC v8","Stage IIA Lung Cancer AJCC v8","Stage IIB Lung Cancer AJCC v8","Stage III Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Unresectable Lung Non-Small Cell Carcinoma","2026-06-26",{"date":290,"type":35},"2026-06-30",{"date":292,"type":35},"2021-12-06",{"date":85,"type":21},{"name":295,"class":241},"Ohio State University Comprehensive Cancer Center",2,{"id":298,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":25,"conditions":301,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":305,"leadSponsor":306,"locationsCount":43},"100614578",{"count":20,"type":21},[24],[27,28,29,30],"2026-06-25",{"date":288,"type":35},{"date":37,"type":21},{"date":39,"type":21},{"name":41,"class":42},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":242},"100576092","phase-2-folfox-botensilimab-and-balstilimab-for-the-treatment-of-localized-rectal-cancer-before-surgery-100576092","NCT06780787","FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery","Phase II Clinical Trial of FOLFOX, Botensilimab, Plus Balstilimab in Patients With Localized Rectal Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n* Histologically confirmed adenocarcinoma of the rectum\n* Rectal involvement defined as involvement of the rectum within 12 cm proximal from anal verge\n* Radial margin of at least 3mm from the mesorectal fascia, with no threatened circumferential tumor margin based on MRI. No more than 4 lymph nodes (LN) with short axis \\> 1 cm\n* T3N0, or TxN1 or TxN2 clinical stage based on MRI staging\n* No evidence of distant metastatic disease based on imaging studies including CT chest and CT or MRI of abdomen and pelvis\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* Without bone marrow involvement: Platelets ≥ 100,000\u002Fmm\\^3\n* Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine \\\u003C 1.5 x ULN or clearance of ≥ 40 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 9 months for women, and at least 6 months for men, after the last dose of oxaliplatin therapy. If patients discontinue oxaliplatin more than 9 months (females) or 6 months (males) before discontinuation of balstilimab and\u002For botensilimab, females and males of childbearing potential must use an effective method of birth control or abstain from sexual activity for the course of the study through at least 120 days after the last dose of balstilimab and\u002For botensilimab\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Any treatment for rectal cancer prior to enrollment that includes (but not limited to) chemotherapy, radiation, and\u002For biological therapy\n* Any prior immunotherapy\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Prior allogeneic organ transplantation\n* Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement or biopsies\n* Concurrent malignancy other than the diagnosis of rectal cancer, with the exception of curatively resected non-melanoma skin cancer, cervical cancer in situ, prostate cancer Gleason 6 or below that is localized to the prostate, or any other curatively resected cancer from which the patient remains in remission for at least 2 years without treatment\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Uncontrolled atrial fibrillation\n* Clinically significant uncontrolled illness\n* Females only: Pregnant or breastfeeding\n* Prior allergic reaction or hypersensitivity to any of the study drug components\n* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs (excluding hypothyroidism, vitiligo, and psoriasis that is controlled with topical management)\n* History of acute thrombotic venous events in the last 30 days before enrollment. If within 30 days, the patient should be on anticoagulants and without symptoms\n* Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study\n* History or current evidence of any condition, co-morbidity, therapy, any active infections (requiring antibiotics), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Known previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 10 days for mild or asymptomatic infections or 20 days for severe\u002Fcritical illness prior to cycle 1 day 1 (C1D1)\n* Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required\n* Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV deoxyribonucleic acid (DNA) for at least 6 months prior to study entry are eligible. Serological testing for HBV at screening is not required\n* Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required\n* Grade 2 or above neuropathy at the time of enrollment\n* Dependence on total parenteral nutrition or intravenous hydration\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":315,"type":21},26,[24],"This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread to other parts of the body (localized). Currently, neoadjuvant therapy for rectal cancer includes chemotherapy and chemoradiation. Despite these aggressive treatments, only about half of patients achieve a complete clinical response. In fact, over half of rectal cancer patients go on to have surgery and often suffer post-surgery complications involving urine and bowel problems. Thus, there has been an increased focus on non-surgical treatments. Chemotherapy drugs, such as fluorouracil, oxaliplatin and leucovorin calcium, 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. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant FOLFOX with botensilimab and balstilimab may improve the rate of complete response and decrease the need for surgery and radiation therapy in patients with localized rectal adenocarcinoma.",[319,320,321],"Rectal Adenocarcinoma","Stage IIA Rectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8",{"date":233,"type":35},{"date":324,"type":35},"2025-05-20",{"date":326,"type":21},"2027-11-05",{"name":328,"class":241},"City of Hope Medical Center",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":338,"briefSummary":339,"conditions":340,"keywords":344,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":242},"100542535","phase-1-hypofractionation-trial-of-re-irradiation-in-good-prognosis-recurrent-glioblastoma-100542535","NCT06344130","Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma","A Phase I Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma","* INCLUSION CRITERIA:\n* Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor.\n* Age \\>= 18.\n* KPS \\>= 70%.\n* Previous tumor irradiation to curative-intent doses.\n* Radiation dose constraints must be achievable based on assessment with MRI and treatment planning CT.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>= 1,000\u002FmicroL\n  * Platelets \\>= 100,000\u002FmicroL\n* Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study entry and through 6 months after the last study treatment (restricted period). Individuals who can father children must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last study treatment.\n* The ability of a participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Recent systemic therapy prior to the initiation of the study therapy as follows:\n\n  * Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.\n  * Temozolomide within 2 weeks.\n  * Cytotoxic chemotherapy within 3 weeks.\n  * Any investigational agents within 2 weeks.\n* Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason.\n* Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy.\n* Requiring radiation therapy within 12 months prior to the initiation of study therapy.\n* History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy.\n* Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in individuals of childbearing potential at screening.\n* Participants with known or suspected radiation sensitivity syndromes.\n* Uncontrolled intercurrent illness evaluated by medical history and physical exam that are not stable and would potentially increase the risk to the participant.","120 Years",{"count":275,"type":21},[219],"Background:\n\nGlioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.\n\nObjective:\n\nTo find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.\n\nEligibility:\n\nPeople aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.\n\nParticipants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.\n\nParticipants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.\n\nParticipants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.\n\nParticipants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.",[341,342,343],"Astrocytoma","Glioma","Recurrent Glioblastoma",[345,346,347],"Radiotherapy","Hypofractionation","Re-irradiation","2026-06-24",{"date":302,"type":35},{"date":351,"type":35},"2024-10-01",{"date":353,"type":21},"2027-12-31",{"name":41,"class":42},{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":17,"minAge":362,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":370,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":296},"100526054","phase-2-repeat-breast-conserving-surgery-followed-by-daily-partial-breast-irradiation-in-ipsilateral-breast-100526054","NCT06129747","Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast","Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation for Participants With Ipsilateral Breast Tumor Recurrence Treated Initially With Breast Conserving Surgery and Whole Breast Radiation Therapy","Inclusion Criteria:\n\n* Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies. Three years of time must have elapsed since the end of the last course of whole breast irradiation.\n* Lesion size \\\u003C 3 cm treated with a partial mastectomy. Participants with invasive cancer and clinically and radiographically negative axillas do not require an axillary lymph node sampling unless they did not have prior axillary lymph node sampling (e.g. previous cancer was DCIS). Participants with DCIS as their recurrence do not require surgical assessment of the axilla. Repeat sentinel lymph node biopsy is permitted.\n* Negative resection margins with at least no tumor on ink or a negative re-excision.\n* Participants with invasive recurrence must have a negative re-staging work-up consisting of either a CT chest\u002Fabdomen and a bone scan or a PET scan.\n* Hormonal therapy is allowed. If chemotherapy is planned, it can be delivered either prior to or after the radiation is delivered. There must be at least 2 weeks between radiation and chemotherapy. HER2 directed therapy can be delivered concurrently with radiation.\n* Participants must be \\> 18 years of age. Because no dosing or adverse event data are currently available on the use of breast re-irradiation in participants ≤18 years of age, children are excluded from this study.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Performance status: ECOG Performance status ≤ 2.\n* Life expectancy of ≥ 12months, in the opinion of and as documented by the investigator.\n* Not based on gender; this trial is open to any gender, defined as self-representation of gender identity.\n\nExclusion Criteria:\n\n* Participants with nodal or distant metastatic disease \\\u003C 3 years since prior radiation.\n* Participants with invasive pure lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or uncontrolled nonepithelial breast malignancies such as lymphoma or sarcoma.\n* Participants with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.\n* Participants with Paget's disease of the nipple.\n* Participants with skin involvement.\n* Participants with scleroderma or dermatomyositis.\n* Participants with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.\n* Participants who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.\n* Participants with known BRCA 1\u002FBRCA 2 mutations.","19 Years",{"count":364,"type":21},55,[24],"The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.",[368,369],"Breast Cancer","Tumor, Breast",[371,372,373,347],"Radiation Therapy","In-Breast Recurrence","Tumor",{"date":302,"type":35},{"date":376,"type":35},"2023-11-30",{"date":378,"type":21},"2029-08-09",{"name":380,"class":241},"Case Comprehensive Cancer Center",{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":389,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":410},"100440030","phase-2-combination-therapy-for-the-treatment-of-diffuse-midline-gliomas-100440030","NCT05009992","Combination Therapy for the Treatment of Diffuse Midline Gliomas","A Combination Therapy Trial Using an Adaptive Platform Design for Children and Young Adults With Diffuse Midline Gliomas (DMGs) Including Diffuse Intrinsic Pontine Gliomas (DIPGs) at Initial Diagnosis, Post-Radiation Therapy and at Time of Progression","PNOC022","--COHORTS 1, 2, AND 3 CLOSED---\n\nINCLUSION CRITERIA:\n\nCOHORT 1A AND 1B:\n\n* New diagnosis of DMG with imaging and\u002For pathology consistent with a DMG, including spinal cord tumors. In cohort 1B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma Histone 3 lysine 27 - mutant (H3K27M); World Health Organization (WHO) grade III and IV H3 wildtype gliomas.\n* Must be within 6 weeks of diagnosis to begin standard of care radiation therapy on study.\n\nCOHORT 2A AND 2B:\n\n* Diagnosis of DMG with imaging and\u002For pathology consistent with a DMG, including spinal cord tumors, who have complete standard-of-care radiation therapy. In Cohort 2B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma H3K27M mutant; WHO grade III and IV H3 wildtype gliomas.\n* Participants must be within 4-14 weeks of completion of radiation. Radiation should have started within 6 weeks of diagnosis.\n\nCOHORT 3A AND 3B:\n\n* Diagnosis of recurrent DMG with imaging and\u002For pathology consistent with a DMG, including spinal cord tumors, who have complete standard-of-care radiation therapy. In cohort 3B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma H3K27M mutant; WHO grade III and IV H3 wildtype gliomas.\n* Participants must have evidence of progression and not have received any treatment for this progression and have not previously received re-irradiation.\n\nCOHORT 4A AND 4B:\n\n* Diagnosis of DMG with imaging and\u002For pathology consistent with a DMG, including spinal cord tumors. In cohort 4B\\^1, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG diffuse midline glioma H3K27-altered.\n* Not currently eligible for any other clinical trials that include administration of ONC201.\n\nCohort 4A\\^1 and 4B\\^1 (participants with newly diagnosed DMG prior to radiation): Must be able to begin standard of care radiation therapy on study within 6 weeks of diagnosis.\n\nCohort 4A\\^2 and 4B\\^2 (participants with newly diagnosed DMG who have completed radiation): Participants must be within 4-14 weeks of completion of radiation and not have received additional therapy beyond completion of radiation therapy. Radiation should have started within 6 weeks of diagnosis.\n\nCohort 4A\\^3 and 4B\\^3 (participants with DMG at progression): Participants must have evidence of progression and not have received any treatment for this progression and have not previously received re-irradiation.\n\nCOHORT 5\n\n* Diagnosis of DMG with imaging and\u002For pathology consistent with a DMG, including spinal cord tumors. In cohort 5\\^1, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG diffuse midline glioma H3K27-altered.\n* Not currently eligible for any other clinical trials that include administration of ONC201.\n* Multifocal and leptomeningeal disease will be eligible for Cohort 5.\n* Participant's tumor must demonstrate one of the following molecular alterations considered targetable by an approved agent:\n\n  * BRAFV600E\n  * PDGFRA (DNA point mutation or amplification with \\>=5 copy numbers)\n  * FGFR1 (DNA point mutation, gene fusions, or amplification with \\>=5 copy numbers)\n  * NF1\n\nCohort 5\\^1 (participants pre-radiation): Must be able to begin standard of care radiation therapy on study within 6 weeks of diagnosis.\n\nCohort 5\\^2 (participants post-radiation): Participants must be within 4-14 weeks of completion of radiation and not have received additional therapy beyond completion of radiation therapy. Radiation should have started within 6 weeks of diagnosis.\n\nCohort 5\\^3 (participants with progression): Participants must have evidence of progression and not have received any treatment for this progression and have not previously received re-irradiation.\n\nAll Cohorts (except Cohort 6):\n\n* Age 2 to 39 years\n* Participants must have recovered from all acute side effects of prior therapy and be beyond the window for expected ongoing acute toxicities. Any number of prior therapies are allowed.\n* Prior ONC201 exposure is allowed, except in participants who have participated in Chimerix trials investigating ONC201 in the upfront setting. Participants who participated in trials investigating ONC201 in the upfront setting will not be eligible at any time, with the exception if participants received ONC201 as part of PNOC022 or other expanded access programs such as German sources of ONC201.\n* Participant body weight must be above the minimum necessary for the participant to receive ONC201 (at least 10 kilograms (kg))\n* From the projected start of scheduled study treatment, the following time periods must have elapsed: At least 7 days after last dose of a biologic agent or beyond time during which adverse events are known to occur for a biologic agent, 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies (21 days for bevacizumab when used for tumor-directed therapy, guidance on use for pseudo-progression is below), or, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies.\n\n  o The use of bevacizumab to control radiation therapy-induced edema is allowed (if used for tumor-directed therapy, please see required time period above).\n  * Dosing limitations are as follows:\n  * \\* Bevacizumab (or equivalent) for up to a maximum of 5 doses, dosing per institutional standard. There is no required washout period.\n* Prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg\u002Fm2 \u002Fdose continuously during radiation therapy for 42 days) or dexamethasone is allowed. Any other agent given throughout radiation therapy must be discussed with the study chairs prior to beginning the agent.\n* Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 3 days prior to baseline magnetic resonance imaging (MRI) scan.\n* The participant must have adequate organ function defined as:\n\n  * Peripheral absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3 (1.0g\u002Fl) AND\n  * Platelet count \\>= 75,000\u002Fmm\\^3 (100x10\\^9\u002Fl) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n  * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 OR\n  * A serum creatinine within the normal limits for age\n  * Bilirubin (sum of conjugated + unconjugated) =\\\u003C 1.5 x upper limit of normal (ULN) for age AND\n  * Serum glutamate pyruvate transaminase (SGPT)(alanine aminotransferase (ALT)) =\\\u003C 3 x ULN AND\n  * Serum albumin \\>= 2 g\u002FDl\n  * No evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry of \\> 92% while breathing room air.\n  * Diarrhea \\\u003C grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0\n  * No history of congestive heart failure or family history of long QT syndrome.\n  * ECG must be obtained to verify the Corrected QT Interval (QTc). If an abnormal reading is obtained, the ECG should be repeated in triplicate. QTC \\\u003C 470 msec.\n  * Participants with history of congestive heart failure, at risk of having or have underlying cardiovascular disease, or with history of exposure to cardiotoxic drugs must have adequate cardiac function as determined by echocardiogram. Shortening fraction of \\>= 27%.\n  * Participants with seizure disorder may be enrolled if seizure disorder is well controlled\n* Females of child-bearing potential and males must agree to use adequate contraception.\n* Karnofsky \\>= 50 for participants \\> 16 years of age and Lansky \\>= 50 for participants =\\\u003C 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Participants must be willing to provide adequate tissue. A minimum of 10-20 paraffin embedded unstained slides OR 1 block with tumor content of 40% or greater is required. Frozen tissue is also acceptable.\n\nCOHORT 6 Inclusion Criteria:\n\n* Diagnosis of newly diagnosed thalamic or pontine located DMG with imaging and\u002For pathology consistent with a DMG, excluding spinal cord tumors, who have completed standard-of-care radiation therapy. If archival tissue is available prior to first biopsy, participants must be willing to provide adequate tissue. A minimum of 10-20 paraffin embedded unstained slides OR 1 block with tumor content of 40% or greater is required.\n* Participants must be within 4-14 weeks of completion of radiation. Radiation should have started within 6 weeks of diagnosis.\n* Age 2-39 years.\n* Prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg\u002Fm2 \u002Fdose continuously during radiation therapy for 42 days) is allowed. Any other agent given throughout radiation therapy must be discussed with the study chairs prior to enrollment.\n* Participants must have recovered from all acute side effects of prior therapy and be beyond the window for expected ongoing acute toxicities. Washout requirements from prior therapy include:\n\n  * At least 7 days after last dose of a biologic agent or beyond time during which adverse events are known to occur for a biologic agent, 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 30 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies (28 days for bevacizumab when used for tumor-directed therapy, guidance on use for pseudo-progression is below), or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies.\n  * At least 4 weeks prior to study enrollment from last immune therapy\n* Corticosteroids: Participants treated with corticosteroids must be on stable or decreasing dose for at least 1 week prior to enrollment, with maximum dexamethasone dose 0.1 mg\u002Fkg\u002Fday dexamethasone equivalent at time of enrollment.\n* The participant must have adequate organ function defined as:\n\n  * Peripheral absolute neutrophil count (ANC) \\>= 750\u002Fmm3 (1.0g\u002Fl) and\n  * Platelet count \\>= 75,000\u002Fmm3 (100x109\u002Fl) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment.\n  * Creatinine clearance or radioisotope GFR \\>= 70mL\u002Fmin\u002F1.73 m2 or\n  * A serum creatinine within the normal limits for age.\n  * Total bilirubin \\\u003C= 3 x upper limit of normal (ULN); in presence of Gilbert's syndrome, total bilirubin \\\u003C\u002F= 6 x ULN or direct bilirubin \\\u003C= 3 x ULN\n  * ALT \\\u003C= 5 x ULN\n  * AST \\\u003C= 5 x ULN.\n  * Serum albumin \\>= 2 g\u002FdL\n  * Diarrhea \\\u003C grade 2 by CTCAE v5.0.\n  * No history of congestive heart failure or family history of long QT syndrome.\n  * Participants with seizure disorder may be enrolled if seizure disorder is well controlled.\n* The effects of the study drugs on the developing human fetus are unknown. For this reason, females of child-bearing potential and males must agree to use adequate contraception.\n* Karnofsky \\>\u002F= 70 for Participants \\> 16 years of age and Lansky \\>\u002F= 70 for participants \\\u003C\u002F= 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n\nEXCLUSION CRITERIA:\n\nCOHORT 1A AND 1B:\n\n* Prior exposure to radiation therapy.\n* Thalamic and Cerebellar H3K27M DMG.\n\nCOHORT 2A AND 2B:\n\n* For tumors that do not have a pontine or spinal cord epicenter the following specific exclusion criteria apply:\n* Thalamic and Cerebellar H3K27M DMG that has undergone standard radiation without concurrent therapy (other than temozolomide).\n\nCOHORT 1A AND 2A:\n\n• Deemed not appropriate for tissue resection\u002Fbiopsy.\n\nCOHORT 3A AND 3B:\n\n* Prior exposure to re-irradiation for tumor progression.\n* Thalamic and cerebellar H3K27M mutant DMG.\n\nCOHORT 4A AND 4B:\n\nCohort 4A\\^1and 4B\\^1: Prior exposure to radiation therapy Cohort 4A\\^3 and 4B\\^3: Prior exposure to re-irradiation for tumor progression\n\n* Thalamic and cerebellar H3K27M mutant DMG, except those who received ONC201\u002FONC026 from alternative source prior to 2024 or US patients enrolled while the accelerated approval new drug application for dordaviprone to treat recurrent H3 K27M-mutant diffuse glioma is under review by US FDA.\n* Cohort 4A\\^1and 4B\\^1: Prior exposure to radiation therapy\n* Cohort 4A\\^3 and 4B\\^3: Prior exposure to re-irradiation for tumor progression\n\nCOHORT 5:\n\n* Thalamic and cerebellar H3K27M mutant DMG, except those who received ONC201\u002FONC026 from alternative source prior to 2024 or US patients enrolled while the accelerated approval new drug application for dordaviprone to treat recurrent H3 K27M-mutant diffuse glioma is under review by US FDA.\n* Cohort 5\\^1: Prior exposure to radiation therapy\n* Cohort 5\\^3: Prior exposure to re-irradiation for tumor progression\n\nAll Cohorts (except Cohort 6):\n\n* Diagnosis of a histone H3 wildtype grade II diffuse astrocytoma.\n* Participants who are currently receiving another investigational drug. Investigational imaging agents or agents used to enhance tumor visibility on imaging or during tumor biopsy\u002Fresection should be discussed with the study chairs.\n* Participants who are currently receiving other anti-cancer agents.\n* Participants with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV) or hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy. Note: Participants that are currently using inhaled, intranasal, ocular, topical or other non-oral or non-intravenous (IV) steroids are not necessarily excluded from the study but need to be discussed with the study chair.\n* Participants with uncontrolled infection or other uncontrolled systemic illness.\n* Female participants of childbearing potential must not be pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated).\n* Active illicit drug use or diagnosis of alcoholism.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in study.\n* Evidence of disseminated disease, including diffuse leptomeningeal disease or evidence of CSF dissemination, with the exception of Cohort 5.\n* Known additional malignancy that is progressing or requires active treatment within 3 years of start of study drug.\n* Concomitant use of potent CYP3A4\u002F5 inhibitors during the treatment phase of the study and within 72 hours prior to starting study drug administration.\n* Concomitant use of potent CYP3A4\u002F5 inducers, which include enzyme inducing antiepileptic drugs (EIAEDs), during the treatment phase of the study and within 2 weeks prior to starting treatment. Concurrent corticosteroids is allowed.\n\nCOHORT 6 Exclusion Criteria:\n\n* • DMGs located outside the thalamus and pons including bilateral thalamic tumors.\n* Unacceptable anesthesia or surgery risk, as determined by the anesthesiologist or the neurosurgeon.\n* Evidence of significant mass effect\n* Evidence of herniation on imaging.\n* Participants with a known history coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhage within 12 months of registration.\n* Participants must not require systemic anti-coagulation that cannot be halted for each intraoperative and perioperative biopsy time-period.\n* Participants with active viral infection or who are currently receiving antiviral treatment.\n* Participants with active, known, or suspected immunosuppressive disorders, such as acquired or congenital immune deficiency syndromes and autoimmune diseases.\n* This virus infects cells with a deficit in the RB gene. Therefore, participants with Li-Fraumeni Syndrome or a known germ line deficit in the retinoblastoma gene or its related pathway are excluded.\n* Participants must not have live or live-attenuated vaccinations within 30 days prior to DNX-2401 administration and while participating in the study. Killed vaccines are permitted.\n* Participants who are currently receiving another investigational drug. Investigational imaging agents or agents used to enhance tumor visibility on imaging or during tumor biopsy\u002Fresection should be discussed with the study chairs.\n* Participants with a known disorder that affects their immune system, such as HIV or Hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy. Note: Participants who are currently using inhaled, intranasal, ocular, topical or other non-oral or non-IV steroids are not necessarily excluded from the study but need to be discussed with the study chair(s).\n* Participants with uncontrolled infection or other uncontrolled systemic illness.\n* Female participants of childbearing potential must not be pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated).\n* Active illicit drug use or diagnosis of alcoholism.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in the study.\n* Evidence of disseminated disease, including multi-focal disease, diffuse leptomeningeal disease or CSF dissemination.","2 Years","39 Years",{"count":392,"type":21},360,[24],"This phase II trial determines if the combination of ONC201 with different drugs is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and there are few treatment options. This trial will utilize an adaptive platform design in that the different treatment arms for each cohort will be opened and closed based on ongoing preclinical investigation as well as evolving outcome data from the trial.\n\nNovel agents will be continuously added to this study as pre-clinical data emerge to suggest additive or synergistic activity when combined ONC201. Should a novel agent not have an RP2D at the time of incorporation into this study, a phase 1 lead-in will be performed prior to initiation of combination therapy (via study amendment).",[396,397,398,399,400,401],"Diffuse Intrinsic Pontine Glioma","Diffuse Midline Glioma, H3 K27M-Mutant","Recurrent Diffuse Intrinsic Pontine Glioma","Recurrent Diffuse Midline Glioma, H3 K27M-Mutant","Recurrent WHO Grade III Glioma","WHO Grade III Glioma","2026-06-23",{"date":288,"type":35},{"date":405,"type":35},"2021-10-20",{"date":407,"type":21},"2029-06-30",{"name":409,"class":241},"University of California, San Francisco",32,{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":436},"100589739","phase-3-testing-higher-dose-radiation-therapy-for-locally-advanced-pancreatic-cancer-100589739","NCT06958328","Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer","A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100)","LAP100","Inclusion Criteria:\n\n* At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine\u002Fnab-paclitaxel. Patients are permitted to receive more than 1 type of chemotherapy for toxicity reasons, but not for disease progression. \"Active chemotherapy\" refers to time on chemotherapy not counting treatment breaks (i.e. if a patient had 1 month of chemotherapy followed by 1 month break, this would count as 1 month chemotherapy). Study registration must occur within 45 days of last day of chemotherapy cycle\n* BASELINE PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:\n* Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma\n* Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network \\[NCCN\\] guidelines and institutional tumor board review)\n* Patients must have baseline pre-chemotherapy scans for staging. Options include: CT chest\u002Fabdomen\u002Fpelvis, CT chest\u002FMRI abdomen\u002Fpelvis, CT chest\u002FCT pelvis\u002FMRI abdomen, or PET\u002FCT performed prior to enrollment\n* Age ≥ 18 years\n* Performance status Eastern Cooperative Oncology Group (ECOG) 0-2\n* Required initial laboratory values:\n\nAll laboratory values must be obtained any time prior to initiation of chemotherapy up to 30 days post initiation of chemotherapy\n\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)\n* BASELINE CA19-9 AND BILIRUBIN REQUIREMENTS: The purpose is to obtain a baseline CA19-9 in the setting of a normal (or close to normal) bilirubin, since serologic response by serial CA19-9 measurements is part of post-chemotherapy eligibility criteria\n\n  * If baseline CA19-9 \\> 37 U\u002FmL the concurrent bilirubin must be ≤ 1.5 x ULN. (Note: if the bilirubin is not ≤ 1.5 x ULN both the CA19-9 and concurrent bilirubin can be repeated until bilirubin is ≤ 1.5 x ULN, as long as done within specified timeframe \\[up to 30 days post chemotherapy initiation\\])\n  * If baseline CA19-9 U\u002FmL ≤ 37, there are no restrictions on the required concurrent bilirubin level, and this can be the accepted baseline value\n\n    * Prior radiation treatment\n* Has the patient had prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Prior non-overlapping radiation (e.g., breast, head and neck, extremity) is permitted\n* If uncertain about prior overlap, please contact the study principal investigator, Dr. Nina Sanford\n\n  * POST PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:\n  * If baseline CA19-9 is elevated (defined as \\> 37 u\u002FmL) the post-pre-entry chemotherapy CA19-9 must be less than 37 u\u002FmL or a 50% decline from pre-chemotherapy level with absolute value less than 100u\u002FmL\n  * If baseline CA19-9 is not elevated (defined as ≤ 37 u\u002FmL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u\u002FmL\n  * No active duodenal or gastric ulcers\n  * No direct tumor invasion of the bowel or stomach\n  * Restaging scans showing at least stable disease (no progression). Options for scans include: CT chest\u002Fabdomen\u002Fpelvis, CT chest\u002FMRI abdomen\u002Fpelvis, or CT chest\u002FCT pelvis\u002FMRI abdomen, or PET\u002FCT performed prior to enrollment, with restaging CT showing at least stable disease\n  * Not pregnant and not nursing\n  * No cardiac condition that was the primary reason for hospitalization in the last 6 months\n  * New York Heart Association Functional Classification II or better (NYHA Functional Classification III\u002FIV are not eligible) (Note: 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.)\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial",{"count":420,"type":21},356,[54],"This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.",[424,425,426,427],"Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","2026-06-22",{"date":302,"type":35},{"date":431,"type":35},"2025-08-21",{"date":433,"type":21},"2030-10-21",{"name":435,"class":241},"NRG Oncology",322,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":451,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":457,"locationsCount":242},"100609700","phase-1-neoadjuvant-complete-response-customized-treatment-approach-for-definitive-management-of-breast-cancer-100609700","NCT07217990","Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer","NoCUT-BC","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 years or older\n4. Early-stage breast cancer diagnosis (cT1-3 N0 or cT1-2 N1) and a Human Epidermal Receptor 2 (HER2)-positive or triple negative breast cancer (TNBC) tumor molecular subtype\n5. Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT)\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Inmate or prisoner\n3. Treatment with an investigational drug or other intervention throughout their breast cancer treatment\n4. Patients with skin involvement and\u002For distant metastases",{"count":445,"type":21},84,[219,24],"This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.",[368,449,450],"HER2-positive Breast Cancer","Triple Negative Breast Cancer","NOT_YET_RECRUITING","2026-06-20",{"date":348,"type":35},{"date":455,"type":21},"2026-09-15",{"date":353,"type":21},{"name":295,"class":241},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":22,"phases":467,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":480},"100575307","phase-2-testing-the-addition-of-the-immunotherapy-drug-pembrolizumab-to-radiation-therapy-compared-to-the-usual-chemotherapy-treatment-during-radiation-therapy-for-bladder-cancer-parrc-trial-100575307","NCT06770582","Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial","Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC Trial)","Inclusion Criteria:\n\n* Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evidence of regional nodal disease or metastatic disease (N0, M0) on CT, MRI, or positron emission tomography (PET)\u002FCT scan who would otherwise be treated with cystectomy off-trial. Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial.\n\n  * NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible\n* High grade T1 disease history that must meet at least ONE of the three criteria below:\n\n  * Histologically confirmed recurrence with high-grade T1 urothelial carcinoma (+\u002F- focal carcinoma in situ \\[CIS\\]) in the bladder following initial transurethral resection of bladder tumor (TURBT) and at least one induction course of intravesical therapy. Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy when BCG is not available.\n  * T1 with pathologic high-risk features (lymphovascular invasion \\[LVI\\] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features) post initial TURBT. (No prior intravesical therapy required)\n  * Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+\u002F- focal CIS) in the bladder. (No prior intravesical therapy required)\n* Restaging TURBT must be performed and must meet ALL of the following criteria below:\n\n  * If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT.\n  * All grossly visible papillary tumors must be removed\n\n    * Note: If the restaging TURBT is performed outside of the enrolling institution, an office cystoscopy should be performed by a Urologist who will be following the patient as part of the clinical trial\n* No pure squamous cell carcinoma or adenocarcinoma of the bladder\n* No neuroendocrine (small or large cell) features\n* No diffuse carcinoma in situ determined on cystoscopy and biopsy (i.e. extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator)\n* No prostatic urethral involvement\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation or who is not postmenopausal\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* Adequate renal function defined as creatinine clearance (CrCL) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula, ≤ 1.5 × upper limit of normal (ULN) or creatinine levels \\> 1.5 × institutional ULN\n* Total bilirubin ≤ institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* All adverse events of their most recent therapy\u002Fintervention must have resolved to \\\u003C grade 3 or returned to baseline prior to registration\n* No history of pelvic radiation therapy\n* No prior systemic chemotherapy or immunotherapy for urothelial carcinoma. Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed\n* No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation\n* No live vaccine administered within 30 days of registration. All non live vaccines (including the coronavirus disease \\[COVID\\] vaccine) are allowed at any time during the study. Timing should minimize confusion with drug-related toxicities where possible\n* Patients must have recovered from acute cardiac illness\n* New York Heart Association Functional Classification II or better (New York Heart Association \\[NYHA\\] Functional Classification III\u002FIV are not eligible) (Note: 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.)\n* No active infection requiring IV antibiotics\n* No active autoimmune disease that required systemic treatment in the 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, etc.) is not considered a form of systemic treatment\n* No history of idiopathic pulmonary fibrosis, organizing pneumonia, (non-infectious) pneumonitis that required steroids or current pneumonitis\n* No history of allogeneic bone marrow transplant or prior solid organ transplant\n* No active tuberculosis\n* No evidence of hydronephrosis\n* No history of upper tract urothelial carcinoma within 24 months of registration\n* No patients with a prior diagnosis of prostate cancer who have not received definitive treatment for their prostate cancer (e.g. on active surveillance)\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* No glucocorticoids except physiologic doses are allowed. The use of doses of corticosteroids (defined as 10 mg prednisone or equivalent) is acceptable\n* No history of allergic reaction to the drug excipients",{"count":466,"type":21},160,[24],"This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. 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. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, 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. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer.",[470,471,472],"Non-Muscle Invasive Bladder Urothelial Carcinoma","Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma","Stage I Bladder Cancer AJCC v8","2026-06-19",{"date":402,"type":35},{"date":476,"type":35},"2025-06-03",{"date":478,"type":21},"2032-02-01",{"name":41,"class":42},134,{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":502},"100525057","phase-1-a-study-of-jnj-86974680-in-participants-with-advanced-non-small-cell-lung-cancer-100525057","NCT06116786","A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer","A Phase 1 Study of JNJ-86974680, an A2a Receptor Antagonist, Administered as Monotherapy and in Combination With Cetrelimab and Radiotherapy for Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Individuals with histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC)\n* Part 1: NSCLC with a known actionable genetic mutation (for example, epidermal growth factor receptor \\[EGFR\\], anaplastic lymphoma kinase \\[ALK\\], c-ros oncogene 1 \\[ROS1\\], v-raf murine sarcoma viral oncogene homolog B1 \\[BRAF\\]) must have received all approved targeted therapies and have progressed\n* Part 2: No targetable mutations (for example, EGFR \\[epidermal growth factor receptor\\], ALK \\[anaplastic lymphoma kinase\\], ROS1\\[c-ros oncogene 1\\], and BRAF \\[B-Raf proto-oncogene, serine\u002Fthreonine kinase\\])\n* Part 1 and Cohort A of part 2: Must have been treated with (a) anti-programmed death protein 1 (anti-PD-1) or programmed cell death ligand 1 (PD-L1) therapy and (b) platinum-based chemotherapy\n* For Cohort B of Part 2: Previously treated with anti-PD-1\u002FPD-L1 therapy for metastatic disease as the prior line of therapy\n* For Cohort C of Part 2: Treatment naïve\n* Adequate organ function\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease involvement\n* Active autoimmune disease\n* Active infection\n* History of solid organ or hematologic stem cell transplantation",{"count":489,"type":21},126,[219],"The purpose of this study is to determine a safe and tolerable dose(s) of JNJ-86974680 for further research in combination with cetrelimab and radiation therapy.",[493],"Carcinoma, Non-small-Cell Lung",{"date":348,"type":35},{"date":496,"type":35},"2023-11-27",{"date":498,"type":21},"2029-06-07",{"name":500,"class":501},"Johnson & Johnson Enterprise Innovation Inc.","INDUSTRY",15,{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":510,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":242},"100435211","phase-2-androgen-ablation-therapy-with-or-without-niraparib-after-radiation-therapy-for-the-treatment-of-high-risk-localized-or-locally-advanced-prostate-cancer-100435211","NCT04947254","Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer","Phase II Trial of Primary Radiotherapy With Androgen Ablation With or Without Adjuvant Niraparib for Selected High-Risk Locoregional Prostate Cancer","Inclusion Criteria:\n\n* Completion of informed consent prior to any study specific procedures. Consent may be done remotely.\n* Patients must agree to tissue collection for correlative studies at the specified timepoints\n* Male aged 18 years and above\n* Histologically or cytologically confirmed prostate carcinoma\n* Localized or regional high-risk disease as defined by at least one of the following features: Prostate specific antigen (PSA) \\> 20 ng\u002FmL, T3a or higher, grade group 4-5 (i.e. Gleason score ≥ 8) as per National Comprehensive Cancer Network (NCCN) Prostate Cancer Version 2.2020 for high risk or very high risk prostate cancer, and\u002For regional lymph nodes positive for prostate cancer\n* Planned for definitive treatment of local regional prostate cancer using XRT and androgen ablation\n* Willing to undergo ongoing medical castration to maintain testosterone levels of ≤ 50 ng\u002FdL (≤ 2.0 nM) throughout systemic treatment or have undergone bilateral orchiectomy\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. Patients must have adequate organ and bone marrow function measured within 7 days prior to treatment registration as defined below:\n* Hemoglobin ≥ 10.0 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n* White blood cells (WBC) \\> 3 x 10\\^9\u002FL\n* No features suggestive of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) on peripheral blood smear\n* Platelet count ≥ 100 x 10\\^9\u002FL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert's disease). (Note: In subjects with Gilbert's syndrome, if total bilirubin is \\> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible.)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 x institutional upper limit of normal\n* Calculated creatinine clearance (Cockcroft-Gault Equation) ≥ 30 mL\u002Fmin\n* Serum Albumin ≥ 3.0\n* Serum potassium ≥ 3.5 mmol\u002FL\n* Able to swallow study drugs whole as a tablet\u002Fcapsule\n* Patients who have partners of childbearing potential (e.g. female that has not been surgically sterilized or who are not amenorrheic for ≥ 12 months) must be willing to use two methods of birth control including adequate barrier protection during the study and for 4 months after last dose of niraparib, abiraterone acetate, and\u002For apalutamide administration. In addition men should not donate sperm during this period. Please note that the efficacy of hormonal contraception may be decreased if administered with niraparib, abiraterone acetate, and\u002For apalutamide\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry\n\nExclusion Criteria:\n\n* Any prior systemic treatment for prostate cancer with the exception of ADT started within 6 months of trial enrollment. Any prior PARP inhibitor therapy\n* Patients who have prostate cancer with distant metastatic disease\n* Patients who have had prior major surgery (prostatectomy) or radiotherapy for the treatment of prostate cancer\n* Any unresolved toxicity (Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade ≥ 2) from previous anti-cancer therapies\n* History or current diagnosis of MDS\u002FAML, and\u002For history of any malignancy \\[other than the one treated in this study\\] which has a ≥ 30% probability of recurrence within 24 months (except for adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or Ta urothelial carcinomas)\n* Active uncontrolled infection (patients completing a course of antibiotic or antiviral therapy whose infection is deemed to be controlled may be allowed on study after discussion with the principal investigator \\[PI\\]; the PI will serve as the final arbiter regarding eligibility)\n* Active or symptomatic viral hepatitis or chronic liver disease\n* Active pneumonitis or extensive bilateral lung disease of non-malignant etiology\n* Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples include, but are not limited to superior vena cava syndrome, extensive bilateral lung disease on high resolution computed tomography (HRCT) scan, uncontrolled seizures, history of allogeneic organ transplant, history of primary immunodeficiency or any psychiatric disorder that prohibits obtaining informed consent\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of study medication\n* Patients with a known hypersensitivity to niraparib, apalutamide, and\u002For abiraterone acetate\n* Prisoners or subjects who are involuntarily incarcerated\n* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness\n* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \\[CNS\\] or meningeal disease which may require treatment with surgery or radiation therapy)\n* Severe or unstable angina, myocardial infarction (within 6 months prior to enrollment), symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), uncontrolled hypertension, or clinically significant ventricular arrhythmias within 6 months prior to randomization\n* Current evidence of any of the following:\n\n  * Gastrointestinal disorder affecting absorption\n  * Active uncontrolled infection (e.g., human immunodeficiency virus \\[HIV\\] or viral hepatitis)\n  * Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone\u002Fprednisolone once daily\n  * Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency\n  * Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate\n  * Baseline moderate and severe hepatic impairment (Child-Pugh class B \\& C)\n  * Any condition that in the opinion of the investigator, would preclude participation in this study","MALE",{"count":512,"type":21},200,[24],"This phase II trial studies the effect of androgen ablation therapy with or without niraparib after standard of care radiation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Androgen ablation therapy (also known as hormone therapy) lowers the levels of male hormones called androgens in the body. Androgens stimulate prostate cancer cells to grow. There are 2 types of androgen ablation therapy given in this study: AAP + ADT and Apa + ADT. AAP + ADT is the treatment combination of the drugs abiraterone acetate and prednisone (AAP) given with androgen deprivation therapy (ADT, also known as androgen deprivation therapy or androgen suppression medication, which is used as standard of care to lower testosterone levels in men with high risk localized or metastatic prostate cancer). Apa + ADT is the treatment combination of the drug apalutamide (Apa) given with ADT. Androgen ablation therapy with or without niraparib after radiation therapy may help to control the disease in patients with prostate cancer.",[516,517,518,519,520,521,522],"Prostate Carcinoma","Stage IIC Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IIIA Prostate Cancer AJCC v8","Stage IIIB Prostate Cancer AJCC v8","Stage IIIC Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8",{"date":402,"type":35},{"date":525,"type":35},"2021-08-05",{"date":527,"type":21},"2028-06-07",{"name":529,"class":241},"M.D. Anderson Cancer Center",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":537,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":22,"phases":541,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":557},"100359362","phase-3-inotuzumab-ozogamicin-and-post-induction-chemotherapy-in-treating-patients-with-high-risk-b-all-mixed-phenotype-acute-leukemia-and-b-lly-100359362","NCT03959085","Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy","A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy","Inclusion Criteria:\n\n* B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.\n* APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.\n* Patients must be \\> 365 days and \\\u003C 25 years of age\n* Initial white blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-9.99 years: WBC \\>= 50,000\u002FuL\n  * Age 10-24.99 years: Any WBC\n  * Age 1-9.99 years: WBC \\\u003C 50,000\u002FuL with one or more of the following:\n\n    * Testicular leukemia\n    * CNS leukemia (CNS3)\n    * Steroid pretreatment.\n* Initial white blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction.\n* Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \\[WHO\\] 2016 criteria) with \\>= 25% blasts on a bone marrow (BM) aspirate;\n\n  * OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;\n  * OR A complete blood count (CBC) documenting the presence of at least 1,000\u002FuL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.\n* Patient has newly diagnosed B-LLy Murphy stages III or IV.\n* Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.\n* Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.\n* Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. Note that once cerebrospinal fluid (CSF) has been collected, protocol therapy can be initiated while final determination of CNS status is pending. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.\n* Direct bilirubin \\\u003C 2.0 mg\u002FdL (34 micromoles\u002FL)\n* Alanine aminotransferase (ALT) ≤ 10x upper limit of normal (ULN). For the purposes of this study, the ULN for ALT is defined as 45 U\u002FL\n* Exceptions to this include patients with known Gilbert's Syndrome, or those with hepatic involvement from leukemic or lymphomatous infiltration\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 NCI requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patients with Down syndrome are not eligible\n* With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.\n* Patients who have received \\> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.\n* Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \\> 1,000\u002FuL circulating leukemia cells.\n* Patients with acute undifferentiated leukemia (AUL) are not eligible.\n* For Murphy stage III\u002FIV B-LLy patients, or stage I\u002FII patients with steroid pretreatment, the following additional exclusion criteria apply:\n\n  * T-lymphoblastic lymphoma.\n  * Morphologically unclassifiable lymphoma.\n  * Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.\n* Patients with known Charcot-Marie-Tooth disease.\n* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.\n* Patients requiring radiation at diagnosis.\n* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n* Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.","365 Days","25 Years",{"count":540,"type":21},5951,[54],"This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol 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. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab.\n\nThe overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.",[102,544,545,546,547],"B Lymphoblastic Lymphoma","Central Nervous System Leukemia","Mixed Phenotype Acute Leukemia","Testicular Leukemia","2026-06-18",{"date":428,"type":35},{"date":551,"type":35},"2019-10-31",{"date":553,"type":21},"2032-03-31",{"name":555,"class":556},"Children's Oncology Group","NETWORK",230,{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":22,"phases":566,"briefSummary":568,"conditions":569,"keywords":574,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":587},"100448857","remaster-recurrent-brain-metastases-after-srs-trial-100448857","NCT05124912","REMASTer: REcurrent Brain Metastases After SRS Trial","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Patients with radiographically proven (by gadolinium-enhanced \\[Gd-\\] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer.\n2. Patients with a \"targetable\", bidimensionally-measurable, intracranial lesion that is radiographically recurrent after previous treatment with SRS +\u002F- surgery (craniotomy or LITT). To classify a lesion as radiographically progressive, the lesion must demonstrate a ≥ 25% increase in size following treatment based on the Neuro-Oncology Criteria of Tumor Response for CNS Tumors. To be \"targetable\" for this study, the lesion should be coverable through a planned single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. An intra-operative decision to utilize two trajectories is acceptable and patient may remain on study.\n3. Patient must be at least 3 months post initial SRS treatment of the target lesion\n4. Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon.\n5. Frozen pathology diagnosis must be attainable.\n6. Patient must be symptomatically stable for a minimum of 3 days prior to the procedure date on a on a max total daily steroid dose equivalent to 4mg of Dexamethasone.\n7. ≥18 years of age\n8. KPS ≥70\n9. Patient is able and willing to complete study requirements\n10. Patients with adequate hematologic parameters (all tests to be performed within \\\u003C4 weeks of biopsy):\n\n    1. ANC ≥ 1.5 X 109\u002FL\n    2. Platelet count ≥ 100 x 109\u002FL\n11. Blood chemistry laboratory value for serum creatinine \\\u003C 1.5 x ULN (test to be performed within \\\u003C4 weeks of biopsy)\n12. Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and\u002For hysterectomy or to those patients who are postmenopausal)\n13. All patients of reproductive potential must agree to use an effective method of contraception during the study\n14. Patients must be accessible for follow-up\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Patients with greater than 3 progressing lesions at time of enrollment. To classify as a radiographically progressive, lesion must demonstrate a ≥ 25% increase in size following treatment based on the RANO criteria. Of note, there is no exclusion for total number of metastases. However, only one lesion can be selected to be the targeted lesion and this lesion alone may be ablated during the study procedure.\n2. Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches.\n3. Prior bevacizumab use within 4 weeks of study initiation\n4. Patients with additional concurrent malignancies requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix\n5. Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to complete the protocol related QOL questionnaires and cognition assessments\n6. Inability to tolerate or contraindication to steroid therapy (i.e., dexamethasone)\n7. Deemed ineligible or unable to tolerate SRS therapy by treating neurosurgeon and\u002For radiation oncologist\n8. Patients with any condition that would prohibit them from undergoing a surgical procedure, at the discretion of the treating physician team\n9. Patients unwilling or unable to give consent for participation\n10. Patients unable to comply with study requirements\n11. Patients with diffuse leptomeningeal disease\n12. Patients with rapidly progressing extracranial disease",{"count":565,"type":21},261,[567],"NA","Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.",[570,571,572,573],"Brain Metastases","Radiation Necrosis","Recurrent Tumor","Recurrent Metastases",[575,576,577,578,571,570],"Laser Interstitial Thermal Therapy","Stereotactic Radiosurgry","LITT","SRS","2026-06-17",{"date":548,"type":35},{"date":582,"type":35},"2022-05-10",{"date":584,"type":21},"2028-10",{"name":586,"class":501},"Monteris Medical",9,""]