[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alliance for Clinical Trials in Oncology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":668},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,42,64,95,116,139,173,194,232,255,275,296,320,343,365,386,408,428,461,482,563,583,602,623,645],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100617671","phase-3-testing-the-addition-of-anti-cancer-drug-sonrotoclax-to-the-standard-treatment-zanubrutinib-for-previously-untreated-cllsll-100617671",false,"NCT07321652","Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL\u002FSLL","Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL)","Inclusion Criteria:\n\n* STEP 0: This bone marrow or peripheral blood submission to Adaptive is mandatory prior to registration\u002Frandomization for real-time identification of the clone needed for MRD testing. The bone marrow sample should be from the first aspiration (i.e., first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be obtained as soon after pre-registration as possible to confirm registration eligibility\n* STEP 0: Patients must be diagnosed with CLL\u002FSLL according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria that includes all of the following:\n\n  * ≥ 5 x10\\^9 \u002FL B lymphocytes (5000\u002FμL) in the peripheral blood (CLL) or a lymph node biopsy demonstrating SLL with the below immunophenotype (SLL)\n  * On morphologic review, the leukemic cells must be small mature lymphocytes\n  * Immunophenotype of CLL cells (performed locally) must reveal a clonal B-cell population, which coexpress the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in \\> 10% of cells must lack t(11;14) translocation by interphase cytogenetics\n* STEP 0: Patients must meet criteria for treatment as defined by IWCLL 2018 guidelines which includes at least one of the following criteria:\n\n  * Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia), typically hemoglobin (Hb) \\\u003C 10 g\u002FdL, platelet count \\\u003C 100,000\u002Fmm\\^3\n  * Massive (\\> 6 cm below the costal margin), progressive or symptomatic splenomegaly\n  * Massive nodes (ie, \\> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy\n  * Autoimmune anemia and\u002For thrombocytopenia that is poorly responsive to standard therapy\n  * Constitutional symptoms, which include any of the following:\n\n    * Unintentional weight loss of ≥ 10% within the previous 6 months\n    * Significant fatigue (ie. Eastern Cooperative Oncology Group \\[ECOG\\] performance status \\[PS\\] ≥ 2)\n    * Fevers \\>100.5 °F or 38.0°C for 2 weeks or more without evidence of infection\n    * Night sweats \\> 1 month without evidence of infection\n* STEP 0: Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)\n* STEP 0: Treatment with rituximab and\u002For high-dose corticosteroids for autoimmune complications of CLL must be completed prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg\u002Fday of prednisone or equivalent corticosteroid at the time of registration\n* STEP 0: Age ≥ 65 years\n* STEP 0: ECOG performance status ≤ 2\n* STEP 0: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n* STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* STEP 0: 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* STEP 0: Patients must not be receiving active systemic anticoagulation with warfarin. Patients must be off warfarin therapy for at least 5 half-lives washout and with normal INR prior to enrollment\n* STEP 0: 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 must be class 2B or better.\n\nPatients with acute cardiac events within 6 months prior to registration should be carefully evaluated for their suitability for enrollment\n\n* STEP 0: No patients with a history of a severe bleeding disorder or a history of hemorrhagic stroke or intracranial hemorrhage\n* STEP 0: No patients with known active progressive central nervous system (CNS) disease\n* STEP 0: No known medical condition causing an inability to swallow oral formulations of agents\n* STEP 1: The adaptive report confirming a measurable and trackable B cell clone\n* STEP 1: Patients may not have had major surgery within 7 days of enrollment, or minor surgery within 5 days of enrollment. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician\n* STEP 1: No patients with ongoing active fungal, bacterial or viral infection requiring systemic therapy except those described in the protocol document\n* STEP 1: Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily\n* STEP 1: Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics\n* STEP 1: Patients must not have continued requirement for therapy with a strong CYP3A4\u002F5 inhibitor or inducer. Any such inhibitor or inducer must have been discontinued at least 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug\n* STEP 1: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3 unless due to marrow involvement\n* STEP 1: Platelet count ≥ 30,000\u002Fmm3\n* STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless due to liver involvement, hemolysis or Gilbert's disease)\n* STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x upper limit of normal (ULN) unless due to disease infiltration of the liver\n* STEP 1: Calculated (calc.) creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) ≥ 30 mL\u002Fmin\n* STEP 1: Urine protein to creatinine ratio \\\u003C 1 or urine protein ≤ 1+\n* STEP 2: Detectable MRD ≥ 10 residual clonal cells per million nucleated cells in peripheral blood at the C15 restaging evaluation from ClonoSEQ\n* STEP 2: Response of PR, PR-L, CR, CCR or CRi to zanubrutinib sonrotoclax therapy","ALL","65 Years",{"count":20,"type":21},466,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Giving sonrotoclax and zanubrutinib may be more effective than zanubrutinib alone for the treatment of untreated CLL\u002FSLL.",[27,28],"Chronic Lymphocytic Leukemia","Small Lymphocytic Leukemia","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2026-04-30",{"date":37,"type":21},"2038-09-30",{"name":39,"class":40},"Alliance for Clinical Trials in Oncology","OTHER",152,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100615487","phase-2-a-study-of-targeted-post-surgery-radiation-therapy-for-non-small-cell-lung-cancer-with-remaining-lymph-node-cancer-after-treatment-100615487","NCT07293247","A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment","Involved-Station, Intensity-Modulated Post-Operative Radiation Therapy (I²-PORT) for Resected Non-Small Cell Lung Cancer With Residual Mediastinal Adenopathy After Neoadjuvant Therapy (ypN2)","* Histopathologic diagnosis of NSCLC, may have mixed or multiple histologies but no small cell component\n* No known EGFR mutation or ALK rearrangement\n* No metastatic disease (M0) per most recent PET\u002FCT and head CT\u002FMRI imaging\n* No disease progression per CT chest (including upper abdomen as per standard practice) with intravenous (IV) contrast (unless IV contrast is contraindicated) or FDG-PET performed post-neoadjuvant therapy ≤ 90 days prior to registration, either before or after surgery\n* No metastatic disease (M0) per head CT\u002FMRI imaging\n* Prior treatment with 2-4 cycles of neoadjuvant systemic therapy with any guideline (National Comprehensive Cancer Network \\[NCCN\\]) concordant regimen\n* Lobectomy or greater oncologic surgical resection within 8 weeks prior to registration\n* Complete (R0) resection showing ypN2 disease\n* No prior radiotherapy to the lungs or mediastinum\n* No treatment with a VEGF inhibitor ≤ 90 days prior to registration or plan to treat with adjuvant systemic therapy including a VEGF inhibitor\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n* Platelet count ≥ 50,000\u002Fmm\\^3\n* Calculated (Calc.) creatinine clearance ≥ 30 mL\u002Fmin\n* Total bilirubin ≤ 3 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5 x upper limit of normal (ULN)\n* Not pregnant, because this study involves radiation therapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required\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* Cardiac function: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No idiopathic pulmonary fibrosis requiring anti-fibrotic medication: Patients with idiopathic pulmonary fibrosis or inflammatory\u002Finterstitial lung disease compromising pulmonary function or requiring ongoing treatment with nintedanib, pirfenidone, or other anti-fibrotic drug are excluded\n* HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial","18 Years",{"count":51,"type":21},164,[53],"PHASE2","This phase II trial compares the effect of intensity-modulated post-operative radiation therapy (I²-PORT) followed by standard of care therapy (chemotherapy or immunotherapy) to standard of care therapy alone in treating patients with non-small cell lung cancer (NSCLC) who have remaining lymph node cancer after surgery. Radiation therapy uses high-energy X-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Chemotherapy drugs 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 may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding I²-PORT radiation therapy to standard therapy may be more effective than standard therapy alone in reducing the risk of cancer returning in those who have undergone surgery for NSCLC.",[56],"Lung Non-Small Cell Carcinoma",{"date":32,"type":33},{"date":59,"type":21},"2026-07-14",{"date":61,"type":21},"2032-03-01",{"name":39,"class":40},33,{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100614772","studying-the-pagoda-algorithm-for-chemotherapy-dose-changes-to-prevent-unplanned-treatment-delays-100614772","NCT07283939","Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays","PAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned Delays","Inclusion Criteria:\n\n* \\* REGISTRATION ELIGIBILITY CRITERIA (STEP 1)\n\n  * Histologic confirmation of invasive cancer that is confirmed or suspected to arise from the gastrointestinal (GI) tract\n  * Any stage for which FOLFOX-based chemotherapy is a clinically-indicated, standard-of-care treatment (adjuvant, neoadjuvant, or first-line chemotherapy)\n  * Eligible primary tumor sites include the esophagus, gastroesophageal junction, stomach, small intestine, ampulla of Vater, appendix, colon, rectum, and cancers of unknown primary with suspected GI origin\n  * Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is permitted\n  * The planned duration of FOLFOX-based chemotherapy must be at least four cycles (1 cycle = 14 days)\n  * Cycle 1, day 1 of FOLFOX-based chemotherapy must be completed 1 to 8 days prior to registration\n  * Cycle 1, day 1 of FOLFOX-based chemotherapy must include minimum ordered doses of oxaliplatin (≥ 65 mg\u002Fm\\^2) and infusional 5-FU (2400 mg\u002Fm\\^2\u002F46 hours). Use of the 5-FU bolus is at the discretion of the treating physician\n  * Patients who require primary prophylactic white blood cell growth factor with cycle 1 of FOLFOX chemotherapy due to high risk for fever and neutropenia are not eligible\n  * History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs, to fluorouracil, or to leucovorin, and the excipients in their formulations are not eligible\n  * Age ≥ 18 years\n  * ECOG performance status ≤ 2\n  * Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n  * Platelet count ≥ 100,000\u002Fmm\\^3\n  * Total bilirubin ≤ 3 x upper limit of normal (ULN)\n  * AST (SGOT)\u002FALT (SGPT) ≤ 5 x upper limit of normal (ULN)\n  * Calc. creatinine clearance ≥ 30 mL\u002Fmin\n  * Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 30 days prior to registration is required\n  * Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression\n  * Patients with known HIV infection are eligible if receiving effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration\n  * Patients with known chronic hepatitis B virus (HBV) infection are eligible if HBV DNA is undetectable when measured within 6 months prior to registration\n  * Patients with a known history of hepatitis C virus (HCV) infection are eligible if HCV RNA is undetectable when measured at least 12 weeks after completion of antiviral therapy\n  * Patients with known history or current symptoms of cardiac disease are eligible if the New York Heart Association Functional Classification is class I or II\n  * Patients with a known history of congenital long QT syndrome are ineligible\n  * Patients with known DPD deficiency are ineligible\n* \\* NON-PATIENT (ONCOLOGY PHYSICIAN OR ONCOLOGY ADVANCED PRACTICE PROVIDER ELIGIBILITY:\n\n  * The non-patient provider participant is a medical oncologist or oncology advanced practice provider with responsibility for signing and making necessary modifications to chemotherapy orders for a subject assigned to the intervention arm (Arm B). Non-patient participants may not be enrolled more than once over the course of the study\n  * The non-patient participant must be proficient in the English language\n  * The non-patient participant must be age 21 years or older",true,{"count":73,"type":21},420,[75],"NA","This study seeks to learn whether using the PAGODA algorithm to guide chemotherapy dosing will lower the chance of unplanned delays during chemotherapy for cancer in the gastrointestinal system compared to usual care.",[78,79,80,81,82,83,84,85,86,87],"Ampulla of Vater Carcinoma","Appendix Carcinoma","Carcinoma of Unknown Primary With Gastrointestinal Profile","Colon Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Gastroesophageal Junction Carcinoma","Malignant Digestive System Neoplasm","Rectal Carcinoma","Small Intestinal Carcinoma",{"date":32,"type":33},{"date":90,"type":33},"2026-02-13",{"date":92,"type":21},"2030-05-02",{"name":39,"class":40},344,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100609540","phase-3-testing-addition-of-an-anti-cancer-drug-vorasidenib-to-temozolomide-after-radiation-for-advanced-brain-cancer-100609540","NCT07215910","Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer","Phase III Trial of Radiotherapy Followed by Adjuvant Temozolomide in Combination With the IDH Inhibitor Vorasidenib vs Placebo in IDH-Mutated Newly-Diagnosed Grade 3 Astrocytomas","Inclusion Criteria:\n\n* STEP 0: Histologic diagnosis of astrocytoma, IDH-mutant (central nervous system \\[CNS\\] WHO grade 3)\n* STEP 0: Available diagnostic slides (hematoxylin and eosin staining method \\[H\\&E\\] and immunohistochemical stains for central review)\n* STEP 0: Tissue available for central biomarker testing (CDKN2A\u002FB and1p\u002F19q co-deletion \\[all patients\\], and IDH1\u002FIDH2 \\[if needed\\])\n* STEP 1: Centrally-confirmed diagnosis of astrocytoma, IDH-mutant (CNS WHO grade 3)\n* STEP 1: Presence of IDH1 p.R132 or IDH2 p.172 mutation, confirmed by central review of immunohistochemical stain or molecular testing results, with central confirmation of equivocal results\n* STEP 1: Absence of CDKN2A\u002FB homozygous deletion by central testing\n* STEP 1: Absence of whole arm 1p\u002F19q co-deletion (i.e. intact 1p\u002F19q) by central testing\n* STEP 1: No evidence of spinal or leptomeningeal disease\n* STEP 1: No prior chemotherapy, cranial irradiation, IDH-inhibitor therapy, radiotherapy, vaccine therapy, small-molecule therapy, or laser ablation\n* STEP 1: Prior diagnostic surgery\u002Fresection\u002Fbiopsy ≤ 6 months of registration\n* STEP 1: Planned radiotherapy and adjuvant chemotherapy\n* STEP 1: Age ≥ 12 years\n* STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky performance status \\[KPS\\] ≥ 60%)\n* STEP 1: Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* STEP 1: Hemoglobin ≥ 9 g\u002FdL\n* STEP 1: Platelet count ≥ 100,000\u002Fmm\\^3\n* STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n\n  \\* For patients with Gilbert syndrome, total bilirubin ≤ 1.0 x ULN\n* STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 x ULN\n* STEP 1: Alkaline phosphatase ≤ 2.5 x ULN\n* STEP 1: Creatinine ≤ 2.0 x ULN or calculated (calc.) creatinine clearance \\> 40 mL\u002Fmin\n\n  \\* For patients ≥ 18 years of age, calculated using the Cockcroft-Gault equation. For patients \\\u003C 18 years of age, calculated using the Bedside Schwartz method:\n  * Age: 10 to \\\u003C 13 years; Maximum Serum Creatinine (mg\u002FdL): 1.2 (male) 1.2 (female)\n  * Age: 13 to \\\u003C 16 years; Maximum Serum Creatinine (mg\u002FdL): 1.5 (male) 1.4 (female)\n  * Age: ≥ 16 years; Maximum Serum Creatinine (mg\u002FdL): 1.7(male) 1.4 (female)\n* STEP 1: Not pregnant and not nursing, because this study involves agents whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown\n\n  \\* Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required\n* STEP 1: Women and men of reproductive potential should agree to abstain from sexual intercourse or use two highly effective methods of birth control, at least one of which must be a barrier method, throughout their participation in this study and for at least 90 days after the last dose of vorasidenib. Reproductive status and discussions about birth control measures should be documented in the patient's record. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of birth control. Highly effective forms of birth control are defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, intrauterine hormone release systems, bilateral tubal ligation, condoms with spermicide, or male partner sterilization\n* STEP 1: No severe or intercurrent illness, no active infection that requires systemic anti-infective therapy, and no active infection with an unexplained fever \\> 38.5°C within 7 days prior to registration\n* STEP 1: 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* STEP 1: Patients must be able to tolerate or undergo an MRI\n* STEP 1: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n* STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* STEP 1: 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* STEP 1: No significant active cardiac disease within 6 months prior to registration, including New York Heart Association Functional Classification class III or IV congestive heart failure, myocardial infarction, unstable angina, and\u002For stroke. To be eligible for this trial, patients should be class 2B or better\n* STEP 1: No history of significant (grade ≥ 2) intratumoral or peri-tumoral hemorrhage\n* STEP 1: No known active inflammatory gastrointestinal disease, chronic diarrhea, prior gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition causing an inability to swallow oral formulations of agents. Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential)\n* STEP 1: No known hypersensitivity to any of the components of vorasidenib or temozolomide\n* STEP 1: No other acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or protocol therapy administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study\n* STEP 1: No concurrent use of other investigational agents\n* STEP 1: No concurrent use of alternating tumor treating field (TTField) therapy\n* STEP 1: No concurrent use of therapeutic doses of steroids for glioma. Concurrent use of physiologic doses of steroids (defined as equivalent of ≤ 10 mg prednisone daily) for medical conditions unrelated to glioma is allowed. Corticosteroids administered for reasons related to glioma should be used in the smallest dose possible to control symptoms of cerebral edema and mass effect and discontinued whenever possible.\n* STEP 1: No concurrent use of warfarin sodium or any other Coumadin-derivative anticoagulant. Patients must be off Coumadin-derivative anticoagulants for at least 7 days prior to registration. Low molecular weight heparin (LMWH) and factor Xa inhibitors are allowed\n* STEP 1: No concurrent use of strong and moderate CYP1A2 inhibitors, moderate CYP1A2 inducers, or CYP3A substrates where a minimal concentration change can reduce efficacy. Patients should be transferred to other medications prior to registration\n\nExclusion Criteria:\n\n\\-","12 Years",{"count":104,"type":21},408,[24],"This phase III trial compares the effect of vorasidenib to placebo in combination with usual treatment, temozolomide, in treating patients with newly diagnosed grade 3 astrocytoma after radiation. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Vorasidenib citrate blocks the proteins made by the mutated IDH1 and IDH2 genes, which may help keep tumor cells from growing. It is a type of enzyme inhibitor and a type of targeted therapy. Adding vorasidenib to the usual treatment, temozolomide, may be more effective than temozolomide alone in treating patients with newly diagnosed grade 3 astrocytoma after radiation therapy.",[108],"Astrocytoma, IDH-Mutant, Grade 3",{"date":32,"type":33},{"date":111,"type":21},"2026-07-20",{"date":113,"type":21},"2040-01",{"name":39,"class":40},82,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":123,"minAge":49,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100608382","phase-3-testing-different-dosing-schedules-of-the-anti-cancer-drug-lutetium-177lu-psma-rlt-and-its-effect-on-patients-with-advanced-prostate-cancer-reciprocal-trial-100608382","NCT07200830","Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial","Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)","Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0): Patients must have histological, pathological, and\u002For cytological confirmation of prostate adenocarcinoma\n* PRE-REGISTRATION (STEP 0): Patients must have a positive PSMA PET\u002FCT scan (either gallium Ga 68 gozetotide \\[68Ga-PSMA-11\\], fluorine F 18 piflufolastat \\[18F- DCFPyl\\], or fluorine F 18 flotufolastat gallium \\[18F-rhPSMA-7.3\\]), as defined as uptake greater than liver with no PSMA negative measurable soft tissue disease\n* PRE-REGISTRATION (STEP 0): PSA greater than 2.0 ng\u002FmL\n* PRE-REGISTRATION (STEP 0): Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:\n\n  * Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng\u002FmL\n  * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions\n  * Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Clinical Trials Working Group 3 \\[PCWG3\\] criteria, Scher et al 2016)\n* PRE-REGISTRATION (STEP 0): Patients must have prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL)\n* PRE-REGISTRATION (STEP 0): Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (to include either apalutamide, darolutamide, enzalutamide, or abiraterone)\n\n  \\* ARPI must be stopped at least 4 weeks prior to pre-registration\n* PRE-REGISTRATION (STEP 0): Patients must not have previously received a taxane based chemotherapy regimen for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate carcinoma (mHSPC) or in the neoadjuvant or adjuvant setting is permitted if completed at least 12 months prior to pre-registration\n* PRE-REGISTRATION (STEP 0): Patients must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.)\n* PRE-REGISTRATION (STEP 0): Patients on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to pre-registration are eligible\n* PRE-REGISTRATION (STEP 0): Previous treatment with strontium Sr-89 (strontium-89), samarium Sm-153 (samarium-153), rhenium Re 186 (rhenium-186), rhenium Re 188 (rhenium-188), radium Ra 223 (radium-223) or hemi-body irradiation within 6 months prior to pre-registration is not allowed. Previous PSMA-targeted radioligand therapy is not allowed\n* PRE-REGISTRATION (STEP 0): Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]) within 28 days prior to pre-registration is not allowed\n* PRE-REGISTRATION (STEP 0): Age ≥ 18 years\n* PRE-REGISTRATION (STEP 0): Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n* PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* PRE-REGISTRATION (STEP 0): Platelet count ≥ 100,000\u002Fmm\\^3\n* PRE-REGISTRATION (STEP 0): Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) or \\\u003C 3 x ULN in patients with Gilbert's syndrome\n* PRE-REGISTRATION (STEP 0): Creatinine clearance estimated glomerular filtration rate (eGFR) ≥ 40 mL\u002Fmin\u002F1.73m\\^2 using the Modification of Diet in Renal Disease (MDRD) equation\n* PRE-REGISTRATION (STEP 0): No acute biliary or urinary obstruction\n* PRE-REGISTRATION (STEP 0): Patients with treated\u002Fstable brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n\n  \\* Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast)\n* PRE-REGISTRATION (STEP 0): Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n* PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* PRE-REGISTRATION (STEP 0): 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* PRE-REGISTRATION (STEP 0): 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* PRE-REGISTRATION (STEP 0): No investigational agents within 28 days prior to pre-registration\n* PRE-REGISTRATION (STEP 0): No other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy\n* PRE-REGISTRATION (STEP 0): No known hypersensitivity to the components of the study therapy or its analogs\n* PRE-REGISTRATION (STEP 0): No transfusion within 30 days of pre-registration\n* PRE-REGISTRATION (STEP 0): No symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression\n* PRE-REGISTRATION (STEP 0): Ability to read and comprehend English or Spanish\n* REGISTRATION (STEP 1): Completion of 2 doses of 177Lu PSMA RLT\n* REGISTRATION (STEP 1): PSA decline ≥ 50% between C1 D1 (screening) and C2 D22 +\u002F-3 days\n* REGISTRATION (STEP 1): ECOG Performance Status ≤ 2\n* REGISTRATION (STEP 1): Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* REGISTRATION (STEP 1): Platelet count ≥ 100,000\u002Fmm\\^3\n* REGISTRATION (STEP 1): Creatinine clearance eGFR ≥ 40 mL\u002Fmin\u002F1.73m\\^2 using the Modification of Diet in Renal Disease (MDRD) equation","MALE",{"count":125,"type":21},1524,[24],"This randomized phase III trial examines whether lengthening the dosage interval in an adaptive manner for the prostate cancer drug lutetium 177 Lu PSMA RLT improves quality of life without decreasing lifespan when compared to the standard way this medication is given. This study is for patients with hormone resistant prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Hormone resistant prostate cancer often has many cells containing a protein called prostate-specific membrane antigen (PSMA) on their surface. The normal cells in the prostate do not normally express as much PSMA protein on their surface as cancer cells. Lutetium 177 Lu PSMA RLT binds to the PSMA protein on the tumor cells. It builds up in these cells and gives off radiation that may kill them. Typically, this medication is given at the same dose every 6 weeks for up to 6 doses. In this trial, researchers want to see if treatment following the first two doses of lutetium 177 Lu PSMA RLT can be delayed until there is evidence of disease activity. This may be an effective way to improve quality of life without decreasing lifespan in patients with advanced prostate cancer.",[129,130,131],"Metastatic Castration-Resistant Prostate Carcinoma","Metastatic Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8",{"date":32,"type":33},{"date":134,"type":33},"2026-03-31",{"date":136,"type":21},"2034-09-09",{"name":39,"class":40},102,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":71,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},"100603974","family-communications-after-genetic-testing-100603974","NCT07143487","Family Communications After Genetic Testing","Evaluation of Provider vs. Patient Mediated Cascade Genetic Testing of First-Degree Relatives of Patients With Newly Diagnosed Colorectal Cancer","Inclusion Criteria:\n\n* STEP 1 PROBANDS: Age \\>= 18 years\n* STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV\n\n  * Histologically proven stage I to IV colon or rectal adenocarcinoma (any T or N, M+). Tumors deemed to originate in the colon can extend into\u002Finvolve the small bowel (e.g., those at the ileocecal valve). Tumors will be regarded as originating in the colon if the entire tumor is in the colon. In the case of rectal involvement, the cancer will be considered a rectal primary\n  * Patients with more than one primary colon adenocarcinoma are eligible\n* STEP 1 PROBANDS: No patients with stage 0 or in-situ colorectal cancer\n* STEP 1 PROBANDS: Patients who have had prior malignancies are eligible, including non-invasive cancers\n* STEP 1 PROBANDS: Patients with synchronous second malignancies are eligible\n* STEP 1 PROBANDS: Have not received germline testing in the 2 years prior to enrollment or known hereditary colon cancer syndromes\n* STEP 1 PROBANDS: Patients must have at least 2 living FDRs who meet the eligibility criteria, with whom the patient is willing to share their cancer diagnosis\n* STEP 1 PROBANDS: In order to complete the mandatory patient-completed measures and view the video and receive genetic education and counseling, participants must be able to speak and read English or Spanish\n* STEP 1 PROBANDS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members\n\n  \\* No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician\n* STEP 2 PROBANDS: Probands positive for a pathogenic germline variant (PGV) in a cancer susceptibility gene\n* FDRs: Age \\>= 18 years\n* FDRs: Have not previously received germline genetic testing or known hereditary colon cancer syndromes\n* FDRs: FDRs must reside within the United States, as genetic testing from LabCorp is only available to United States (U.S.) residents\n* FDRs: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish\n\nExclusion Criteria:\n\n\\-",{"count":147,"type":21},4186,[75],"This clinical trial compares patient (proband)-mediated communication to provider-mediated communication for improving genetic testing in first-degree relatives of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of colorectal cancer have a genetic basis and about 15% of these patients have a disease-causing (pathogenic) inherited (germline) variant in a cancer susceptibility gene. Most individuals carrying a pathogenic germline variant are unaware of their cancer risk and may not meet guidelines for genetic testing. Identifying pathogenic germline variants or hereditary cancer syndromes in cancer patients has important implications for their at-risk relatives who may not know that they are at high risk for cancer. The burden of communicating this risk to first-degree relatives often falls on the patients, who may lack sufficient knowledge to correctly share and explain their genetic test results. Receiving provider-mediated communication of genetic testing results may be more effective at communicating genetic risk to first-degree relatives than the usual practice of proband-mediated communication.",[151,152,153,154,155,156,157,158,159,160,161,162,163,164,165],"Colon Adenocarcinoma","Colorectal Adenocarcinoma","Rectal Adenocarcinoma","Stage I Colon Cancer AJCC v8","Stage I Colorectal Cancer AJCC v8","Stage I Rectal Cancer AJCC v8","Stage II Colon Cancer AJCC v8","Stage II Colorectal Cancer AJCC v8","Stage II Rectal Cancer AJCC v8","Stage III Colon Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8","Stage IV Colon Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Rectal Cancer AJCC v8",{"date":32,"type":33},{"date":168,"type":33},"2026-04-06",{"date":170,"type":21},"2032-11-05",{"name":39,"class":40},276,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":71,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100599986","testing-an-enhanced-digital-delivery-model-for-inherited-cancer-genetic-testing-in-young-adults-with-cancer-100599986","NCT07091617","Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer","AYA Access Study: An Enhanced eHealth and Chat-Bot Enabled Delivery Model for Clinical Genetic Services in Community AYA Cancer Patients","* PATIENTS: Age ≥ 18 years and ≤ 39 years at the time of enrollment\n* PATIENTS: AYA cancer patients and survivors. This includes patients at any stage of diagnosis (e.g., newly diagnosed, in treatment, in survivorship) and a cancer diagnosis (including pediatric cancers) at any age ≤ 39 years old. Given targeted therapies for BRCA+ and microsatellite instability (MSI)-high\u002FLynch Syndrome patients and benefit to relatives, patients with metastatic cancer are included. Any history of cancer, regardless of being in treatment or not\n* PATIENTS: Language: In order to complete the mandatory patient-completed measures and receive genetic education and counseling, participants must be able to speak and read English or Spanish\n* PATIENTS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members\n* PATIENTS: No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician\n* PATIENTS: Participants must meet National Comprehensive Cancer Network (NCCN) guidelines for genetic testing assessment provided by Penn Telegenetics by the Eligibility Verification Assessment (EVA) chatbot, or paper forms and genetic counselor's review\n* NON-PATIENT PARTICIPANT: Non-patient participants eligible for this study include: oncology providers, members of the care team and clinic staff, genetic counselors, and insurers (i.e., people who work in financial services and\u002For for insurance companies) who participate in oncology care among AYA in community for this study\n* NON-PATIENT PARTICIPANT: Age ≥ 18 years\n* NON-PATIENT PARTICIPANT: Non-patient participants must be able to speak and read English or Spanish in order to participate in the key informant interviews",{"count":181,"type":21},535,[75],"This phase III trial compares the use of a digital chatbot enabled intervention to standard remote genetic services for increasing uptake of genetic counseling and testing among adolescents and young adult (AYA) cancer patients. Genetic testing for cancer predisposition syndromes has become standard evidence-based practice and can inform enhanced screening and risk reducing measures to reduce cancer morbidity and mortality. Despite this, many AYAs are not receiving recommended genetic counseling and testing. Offering remote telehealth services can address access barriers and chatbots and texting interventions could enhance patient outcomes and reduce provider and staff time. The use of a digital chatbot enabled intervention may be equally as effective as standard remote genetic services in AYA cancer patients undergoing genetic testing.",[185,186],"Miscellaneous Neoplasm, Nos","Non-Neoplastic Condition, Nos",{"date":32,"type":33},{"date":189,"type":33},"2025-12-10",{"date":191,"type":21},"2029-04-30",{"name":39,"class":40},280,{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},"100597545","distance-based-exercise-to-preserve-function-and-prevent-disability-100597545","NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-",{"count":202,"type":21},104,[75],"This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Breast Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gall Bladder Cancer","Gastric Cancer","Kidney Cancer","Liver Cancer","Lung Cancer","Head and Neck Cancer","Ovarian Cancer","Pancreatic Cancer","Prostate Cancer","Rectal Cancer","Sarcoma",{"date":32,"type":33},{"date":227,"type":33},"2026-02-11",{"date":229,"type":21},"2027-08-31",{"name":39,"class":40},18,{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},"100592949","phase-3-testing-the-addition-of-an-anti-cancer-drug-gemcitabine-to-usual-treatment-bcg-alone-in-people-whose-non-muscle-invasive-bladder-cancer-nmibc-came-back-after-prior-bcg-therapy-100592949","NCT07000084","Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy","GAIN-BCG: Gemcitabine Alternating With INtravesical BCG Randomized Against BCG Alone for Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer","GAIN-BCG","Inclusion Criteria:\n\n* Documentation of Disease: Histologic confirmation of urothelial carcinoma that is high grade Ta, high grade T1, or Tis (Tis\u002Fcarcinoma in situ \\[CIS\\] only disease) within 120 days prior to randomization\n* Any component of neuroendocrine carcinoma (i.e., small cell or large cell) is not allowed. Other histologic subtypes\u002Fvariant histologies are allowed so long as there is a predominantly urothelial component.\n\n  \\* Note: Pure squamous cell carcinoma or pure adenocarcinoma without a urothelial component are not allowed\n* All visible papillary lesions must be macroscopically resected by TURBT within 90 days of randomization. (Residual CIS is permitted).\n\n  \\* If the treating urologist did not perform the TURBT, the treating urologist must perform a cystoscopy within 45 days prior to randomization to confirm the absence of visible papillary disease\n* All patients with high grade T1 must undergo a restaging TURBT within 90 days of randomization. Patients who undergo a restaging TURBT that shows no residual cancer in the specimen are still eligible for trial based on prior TURBT\n* Patients must have BCG-Exposed non muscle invasive bladder carcinoma (NMIBC), defined as recurrent high grade NMIBC within 24 months of last BCG exposure but not meeting the definition of BCG unresponsive disease\n\n  * Note: Up to 26 months from the last BCG instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence\u002Fsuspicion of recurrent disease (by positive cytology, imaging, or cystoscopy) within 24 months of last exposure to BCG.\n  * Note: A patient who previously met the definition of BCG unresponsive NMIBC but no longer currently meets unresponsive criteria may still enroll in this trial so long as the treating urologist believes re-treatment with BCG is a reasonable treatment option for that patient.\n  * BCG-exposed NMIBC criteria is defined as:\n\n    * Any high grade NMIBC recurrence within 24 months of induction only BCG, or\n    * A high grade papillary NMIBC (Ta\u002FT1) recurrence between 6-24 months of last exposure to induction + maintenance BCG, or\n    * A high-grade CIS (with or without Ta\u002FT1 papillary disease) recurrence within 12-24 months of last exposure to induction + maintenance BCG.\n  * Patient must not have BCG-unresponsive NMIBC, defined as:\n\n    * Persistent or recurrent high-grade papillary NMIBC (Ta\u002FT1) \\\u003C 6 months of \"adequate\" BCG, or\n    * A high-grade CIS (with or without Ta\u002FT1 papillary disease) recurrence \\\u003C 12 months of \"adequate\" BCG, or\n    * A high grade T1 recurrence at the first 3-month assessment from induction BCG\n    * \"Adequate\" BCG is defined as ≥5 of 6 doses of induction BCG therapy with either\n\n      * ≥ 2 of 3 doses of maintenance BCG, or\n      * ≥ 2 of planned 6 instillations of repeat induction BCG given within a 6 month time period\n* More than one prior induction course of BCG and\u002For prior maintenance BCG is allowed so long as the patient does not currently met the definition of BCG unresponsive disease\n* Prior treatment with any intravesical chemotherapy (both perioperative and induction course) for NMIBC is allowed, including gemcitabine either alone or in combination (ie. gemcitabine plus docetaxel) or gemcitabine delivered through a intravesical delivery system (ie. TAR-200)\n* Prior treatment with any systemic or intravesical agents for NMIBC is allowed, regardless of whether it is given either alone or in prior combination with BCG (ie. Prior treatment with pembrolizumab, other immune checkpoint inhibitors, nadofaragene firadenovec, nogapendekin alfa inbakicept, cretostimogene grenadenorepvec, etc. are all allowed)\n* Patients must not have a history of intolerance to BCG (ie needing to stop BCG induction or maintenance due to toxicity) or intolerance to any other intravesical therapies\n* Patients must not have compromised bladder function such that they are unlikely to tolerate further intravesical therapies\n* Patient must not have any prior history or current evidence of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 120 days prior to randomization.\n\n  \\* The radiographic imaging includes a CT Scan or MRI of the abdomen\u002Fpelvis with intravenous contrast, with a CT or MRI urogram preferred. If a patient is unable to receive intravenous contrast due to renal function or allergy, then either a CT scan or MRI of the abdomen\u002Fpelvis without intravenous contrast is acceptable\n* Patients with a history of upper tract urothelial carcinoma are allowed so long as they had localized non-muscle invasive (Ta, T1, Tis) that has been definitively treated with surgery (nephroureterectomy or ureterectomy) with at least one post-treatment disease assessment imaging study that demonstrates no evidence of residual upper tract disease\n* Patients with a history of, or current evidence of, non-invasive (Ta\u002FTis) urothelial carcinoma of the prostatic urethra are eligible so long as a transurethral resection of prostate (TURP) is performed before enrollment and there is prostatic glandular tissue without evidence of lamina propria invasion or prostatic stromal invasion\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Age ≥ 18 years\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* Not pregnant and not nursing, Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:\n\n  * has achieved menarche at some point\n  * has not undergone a hysterectomy or bilateral oophorectomy\n  * has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)",{"count":241,"type":21},330,[24],"This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.",[245,246,247],"Recurrent Non-Muscle Invasive Bladder Carcinoma","Stage 0a Bladder Cancer AJCC v8","Stage I Bladder Cancer AJCC v8",{"date":32,"type":33},{"date":250,"type":33},"2025-07-17",{"date":252,"type":21},"2028-12-05",{"name":39,"class":40},58,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":123,"minAge":49,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":274},"100587665","phase-3-testing-the-addition-of-docetaxel-chemotherapy-to-the-usual-treatment-hormonal-therapy-and-apalutamide-for-metastatic-prostate-cancer-aspire-trial-100587665","NCT06931340","Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial","Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)","Inclusion Criteria:\n\n* Documentation of disease:\n\n  \\* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology\n* Must have had evidence of metastatic disease (American Joint Committee on Cancer \\[AJCC\\] metastasis \\[M\\]1 disease) based on conventional CT\u002FMRI and\u002For bone scan. This will be defined as:\n\n  * Bone metastases detected by CT, radionuclide technetium-99 (99Tc)- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria; OR\n  * Non-pelvic lymph node metastases (measurable lymph nodes above the aortic bifurcation; lymph nodes are measurable if the short axis diameter is ≥ 15 mm) detected on CT or MRI as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Subjects with regional lymph node metastases only (nodes \\[N\\]1, below the aortic bifurcation) will not be eligible for the study; OR\n  * Visceral or soft tissue metastases detected on CT or MRI as defined by RECIST version 1.1. Soft tissue\u002Fvisceral lesions are measurable if the long axis diameter is ≥ 10 mm\n  * Evidence of metastatic disease by PSMA-PET only and not visible by CT, radionuclide bone scan, or MRI will not satisfy eligibility criteria\n* No metachronous low-volume disease (defined as recurrent metastatic disease after definitive treatment of prostate primary) and with ≤ 4 bone metastasis and no visceral metastasis on conventional imaging by CT, radionuclide 99Tc-biphosphonate bone scan, or MRI)\n* Next generation sequencing (NGS) results from any tissue based Clinical Laboratory Improvement Act (CLIA) test must be available at the time of registration. NGS from soft tissue or visceral lesion if available is preferred. NGS from bone or primary prostate will be accepted. Patients with failed NGS testing are not eligible\n* Prior treatment\n\n  * ADT (luteinizing hormone-releasing hormone \\[LHRH\\] agonist\u002Fantagonist or orchiectomy) with or without first generation anti-androgen, or second-generation androgen receptor signaling inhibitor (ARSI) within 120 days of registration is permitted. No washout period will be needed for the first generation- androgen or ARSI prior to registration. Anti-androgen treatment is only permitted if used within 120 days of registration\n  * No prior chemotherapy for prostate cancer\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Platelet count ≥ 100,000\u002Fmm\\^3\n* Total bilirubin ≤ 1 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \\> 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1 × ULN, subject may be eligible)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate transaminase \\[SGT\\]) ≤ 1.5 x upper limit of normal (ULN)\n* Calculated (Calc.) creatinine clearance \\> 30 mL\u002Fmin\n* Serum potassium ≥ 3.5 mmol\u002FL\n* Comorbid conditions\n\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  * Leptomeningeal metastases: Patients with treated leptomeningeal metastases are eligible if follow-up brain imaging 30 days after central nervous system (CNS)-directed therapy shows no evidence of progression\n  * HIV: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n  * Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n  * Hepatitis C: 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  * No seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation or condition requiring CNS surgery or radiation therapy)\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. Any condition that in the opinion of the investigator, would preclude participation in this study. Patients with stable asymptomatic deep venous thromboembolism on stable anti-coagulation will be eligible\n  * Hypertension: Subjects with uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) \\>= 160 mmHg or diastolic BP \\>= 100 mmHg despite medical management are not permitted to register\n  * Allergies: Subjects with known hypersensitivity to any of the study drugs, or excipients in the formulation of the study drugs are not permitted to register\n* Concomitant medications\n\n  * Chronic concomitant treatment with strong inhibitors of cytochrome P450 3A4 (CYP3A4) is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration on the study. See Section 8.1.9 for more information\n  * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment\n  * Medications known to lower the seizure threshold must be discontinued or substituted prior to study entry. See Section 8.1.9 for more information\n* Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or agrees to use a condom if having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug",{"count":263,"type":21},1260,[24],"This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.",[267,130,131],"Castration-Sensitive Prostate Carcinoma",{"date":32,"type":33},{"date":270,"type":33},"2025-12-01",{"date":272,"type":21},"2039-05-08",{"name":39,"class":40},195,{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":295},"100583468","phase-3-shortstop-her2-12-months-vs-6-months-of-her2-targeted-medications-for-people-with-her2-breast-cancer-who-had-a-pathologic-complete-response-after-chemotherapy-plus-trastuzumab-100583468","NCT06876714","ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab","ShortStop-HER2: Shortened Duration of Adjuvant Therapy in Patients With Early-Stage HER2+ Breast Cancer Who Achieve pCR After Neoadjuvant Chemotherapy With HER2 Blockade","Inclusion Criteria:\n\n* Patients (females and males) with clinical stage T1c-T3 (or Tx) and nodal stage N0-N1 (except T3N1 tumors, which are not eligible)\n* Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Patients with residual isolated tumor cells at surgery are considered node-positive and are not eligible\n* HER2+ by American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines. Central pathology review is not required. In cases where there were multiple tumor sites in breast\u002Fnodes that had HER2 testing at diagnosis, at least one site must have been HER2+ AND the treating investigator must feel it is in the patient's best interest to be treated as having HER2+ breast cancer\n* Known hormone receptor status as defined by ASCO\u002FCAP guidelines. Estrogen receptor (ER) and progesterone receptor (PR) of any values are allowed. Hormone receptor positive status can be determined by either known positive ER or known positive PR status; hormone receptor negative status must be determined by both known negative ER and known negative PR\n* If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors\u002Fbreasts (including the requirement that at least one biopsied site on each side must have been HER2+)\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patients must have received neoadjuvant chemotherapy in combination with trastuzumab with or without pertuzumab for a minimum of 12 weeks. All chemotherapy must have been completed preoperatively\n\n  * Patient must complete a minimum of 12 weeks of coverage with trastuzumab and a maximum of 24 weeks in the combined neoadjuvant and adjuvant setting prior to trial registration. Trastuzumab may have been administered either weekly or once every 3 weeks (q3weeks). (For purposes of this eligibility criterion, a single dose of q3week trastuzumab would provide 3 weeks of coverage; a single dose of once a week (q1week) trastuzumab would provide 1 week of coverage. If a q3week dose of trastuzumab were administered and then the subsequent dose was delayed for any period of time, that would still count as 3 weeks of coverage.)\n  * Administration of endocrine therapy for treatment of this breast cancer is allowed prior to trial registration. If a patient received prior breast cancer endocrine therapy (eg tamoxifen or aromatase inhibitor) for DCIS or preventive indication, and endocrine therapy is indicated for treatment of their current breast cancer, then prior endocrine therapy must have been stopped \\> 12 months prior to registration on this protocol\n  * No use of investigational anti-cancer agents at time of registration\n* Patient must register within 14 weeks of final surgery\n* Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows:\n\n  * Breast surgery: Total mastectomy with grossly negative margins (in the opinion of the surgeon there is no disease grossly at the margins) or breast-conserving surgery with histologically negative margins (no ink on tumor, including DCIS) unless those margins are anterior at the skin or posterior at the chest wall and no additional margin re-excision can be performed\n  * Lymph node surgery: Lymph node surgery must have been performed and can include sentinel lymph node biopsy, targeted axillary dissection, or axillary dissection, at the discretion of the breast surgeon\n* Adequate radiation: Patients who completed breast-conserving surgery (i.e. lumpectomy) must have received or plan to receive adjuvant radiation. If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible. Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation) are not eligible\n\n  * Adjuvant radiation can be given on study, and in this case is encouraged to be given concurrently with adjuvant HER2-directed therapy, per investigator discretion\n  * Targeting of the regional nodal basins will be at treating investigator discretion\n* Not pregnant and not nursing, because this study involves agents with known teratogenic potential. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test should be performed prior to receiving HER2-directed therapy according to local standard practice\n* Adequate hepatic, renal and bone marrow function to receive adjuvant HER2-directed therapy in the opinion of the treating investigator. There are no specific required laboratory values for eligibility\n* No stage IV (metastatic) breast cancer\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 history of any prior (ipsilateral \\[ipsi-\\] or contralateral) invasive breast cancer. Prior DCIS is allowed\n* No evidence of recurrent disease following preoperative therapy and surgery\n* Patients living with HIV who are healthy and deemed by their medical team to have a low risk of AIDS-related illnesses are included in this trial. Patients with Hepatitis B or Hepatitis C virus who are healthy and deemed by their medical team to meet all other enrollment criteria are included in this trial.\n* Patients with inadequate cardiac function on most recent assessment of left ventricular ejection fraction (LVEF) are not eligible for this trial. Inadequate cardiac function is defined as LVEF \\\u003C 50% on echocardiogram (echo) or multiple-gated acquisition (MUGA)\n* No history of grade 3 or 4 toxicity related to trastuzumab. If pertuzumab is planned to be given on trial, patient must also have no history of grade 3-4 toxicity related to pertuzumab\n* No contraindication to receipt of further HER2-directed therapy\n* No patients with severe, uncontrolled systemic disease that may interfere with planned trial therapy.\n\nExclusion Criteria:\n\n\\-",{"count":125,"type":21},[24],"This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.",[286,287,288],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Early Stage HER2+ Breast Cancer",{"date":32,"type":33},{"date":291,"type":33},"2025-09-17",{"date":293,"type":21},"2037-03-13",{"name":39,"class":40},671,{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},"100566941","phase-3-testing-the-addition-of-the-anti-cancer-drug-tivozanib-to-immunotherapy-pembrolizumab-after-surgery-to-remove-all-known-sites-of-kidney-cancer-100566941","NCT06661720","Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer","Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE","STRIKE","Inclusion Criteria:\n\n* • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)\n\n  * Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted\n\n    * Intermediate-high risk RCC:\n\n      * pT2 grade 4 or sarcomatoid features, N0M0\n      * pT3 any grade N0, M0\n    * High-risk RCC\n\n      * pT4, any grade, N0, M0\n      * pT, any stage., any grade, N+, M0\n    * cM1 no evidence of disease (NED) RCC\n\n      * Participants who have had resection of primary tumor (radical or partial nephrectomy) and resection or definitive radiation or ablation of solid, isolated, soft tissue metastases (excluding brain and bone lesions) at the time of primary tumor removal (synchronous) or ≤1 year from primary tumor removal (metachronous)\n\n        * Surgery (radical or partial nephrectomy or metastasectomy or ablation) \\> 4 weeks but =\\\u003C 16 weeks prior to study registration with no ongoing complications from surgery\n        * No evidence of disease at time of randomization as assessed by investigator by either CT or MRI scan of the brain and chest, abdomen and pelvis\n        * No prior systemic treatment for RCC\n        * Age \\>= 18 years\n        * Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (or Karnofsky \\>= 60%)\n        * Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3\n        * Platelet count \\>= 100,000\u002Fmm\\^3\n        * Hemoglobin \\>= 8 g\u002FdL\n        * Total bilirubin =\\\u003C 3 x upper limit of normal (ULN)\n        * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x upper limit of normal (ULN)\n        * Calculated (calc.) creatinine clearance \\>= 30 mL\u002Fmin (using Cockcroft Gault equation or the estimated glomerular filtration rate from the modification of diet in renal disease trial)\n        * Urine protein =\\\u003C 1+ on urine analysis (UA) or urine protein creatinine ration (UPCR) \\\u003C 2mg\u002Fmg\n        * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test is required =\\\u003C 14 days prior to registration\n        * HIV status: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n        * Hepatitis\n  * Hepatitis B: 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 resolved HBV infection, defined as positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antigen (HbsAg), are eligible\n  * Hepatitis C: 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\n    * Cardiac Disease: 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 IIB or better\n    * No history of myocarditis\n    * No history of clinically significant pneumonitis\n    * No uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 150 mm Hg or diastolic BP \\> 90 mm Hg) documented on 2 consecutive measurements taken at least 2 hours apart\n    * No serious non-healing wound, ulcer or bone fracture within 28 days prior to registration\n    * No serious\u002Factive infection requiring parenteral antibiotics\n    * No moderate or severe hepatic impairment (child-Pugh B or C)\n    * No significant bleeding disorders within 1 month prior to registration, for example:\n  * Hematemesis, hematochezia or other gastrointestinal bleeding grade 3 or higher\n  * Hemoptysis of pulmonary bleeding grade 3 or higher\n  * Hematuria or other genitourinary bleeding grade 3 or higher\n\n    * No history of allogeneic organ transplantation\n    * No history of allergy of hypersensitivity to study drugs or components\n    * No condition requiring systemic treatment with either corticosteroid (\\> 10 mg daily or prednisone equivalent) within 14 days of treatment initiation or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement doses ≤10 mg daily prednisone equivalent are permitted in absence of active autoimmune disease\n    * No active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition associated with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to registration\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 patients with a history of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids \\> 10 mg\u002Fday, or immunosuppressive drugs) with the following exceptions:\n  * Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n  * Brief (\\\u003C7 days) use of systemic corticosteroids is allowed when use is considered standard of care\n  * Patients with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma\u002Fatopy will not be excluded\n  * Patients requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded\n  * Patients with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment",{"count":305,"type":21},1040,[24],"This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). 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. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.",[309,310,311,312],"Clear Cell Renal Cell Carcinoma","Renal Cell Carcinoma (RCC)","Stage II Renal Pelvis Cancer AJCC v8","Stage III Renal Pelvis Cancer AJCC v8",{"date":32,"type":33},{"date":315,"type":33},"2025-03-14",{"date":317,"type":21},"2037-11",{"name":39,"class":40},415,{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},"100564680","phase-3-comparing-impact-of-treatment-before-or-after-surgery-in-patients-with-stage-ii-iiib-resectable-non-small-cell-lung-cancer-100564680","NCT06632327","Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer","Perioperative Versus Adjuvant Systemic Therapy in Patients With Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG","Inclusion Criteria:\n\n* Histologically or cytologically confirmed surgically resectable stage IIA to IIIB NSCLC according to the American Joint Committee on Cancer (AJCC) 9th edition (stage IIA to IIIB NSCLC up to single station N2, according to the AJCC 8th edition)\n\n  \\* Note: Patients with resectable stage N2a or T4 are eligible, but patients with stage N2b or N3 are not eligible. Patients with known EGFR or ALK alterations are excluded\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%)\n* No prior systemic treatment for NSCLC within 5 years except stage 1 and 2 cancers treated with curative intent\n* No treatment for another malignancy within 3 years prior to registration, except for stage 1 or 2 cancers treated for curative intent; patients must be disease free for one year prior to registration. Patients with non-melanoma skin cancer, urothelial carcinoma in situ (Tis), noninvasive papillary carcinoma of the urinary bladder (Ta), prostatic intraepithelial neoplasia (PIN), ductal carcinoma in situ (DCIS) of the breast, or cervical intraepithelial neoplasia (CIN) of the uterine cervix are also eligible\n* No active autoimmune disease, interstitial lung disease, or transplant that precludes safe treatment with immune checkpoint inhibitors\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial",{"count":328,"type":21},1100,[24],"This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and\u002For immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. 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 tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, 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 nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.",[332,333,334,335],"Resectable Lung Non-Small Cell Carcinoma","Stage II Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8",{"date":32,"type":33},{"date":338,"type":33},"2024-12-11",{"date":340,"type":21},"2030-04-30",{"name":39,"class":40},382,{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":364},"100533916","phase-1-testing-the-combination-of-two-approved-drugs-and-one-experimental-drug-in-patients-with-relapsed-or-refractory-multiple-myeloma-100533916","NCT06232044","Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma","A Phase I\u002FII Study of the Safety, Tolerability and Efficacy of Belantamab Mafodotin (GSK2857916) in Combination With Iberdomide (CC-220)\u002FDexamethasone Versus Belantamab Mafodotin (GSK2857916)\u002FDexamethasone in Relapsed Refractory Multiple Myeloma","* Documentation of disease: Diagnosis of multiple myeloma and have relapsed or refractory disease according to the IMWG criteria where:\n\n  * Progression of myeloma is defined by IMWG criteria as recurrence of disease after prior response, indicated as any of the following:\n\n    * ≥ 25% increase in M-protein (must be at least 0.5g\u002Fdl above nadir from last treatment regimen).\n    * 25% difference between involved and uninvolved serum free light chains from its nadir or\n    * The development of new plasmacytomas or hypercalcemia.\n  * Refractory myeloma as defined by IMWG criteria as disease which become non-responsive or progresses on therapy or within 60 days of last treatment in patients who had achieved a minimal response or better on prior therapy.\n* Measurable disease defined by IMWG criteria as:\n\n  * Serum M-protein ≥ 0.5 g\u002FdL.\n  * Urine monoclonal protein ≥ 200 mg\u002F24h.\n  * Serum free light chains (FLC) assay: Involved FLC level ≥ 10 mg\u002Fdl (≥ 100 mg\u002Fl) and serum free light chain ratio is abnormal.\n* Two or more prior lines of therapies, triple-class exposed (exposed \u002Frefractory to an immunodulatory derivative (IMiD) and\u002For proteasome inhibitors (PI) and\u002For to daratumumab or other anti-CD38 monoclonal antibody).\n* No prior exposure to iberdomide or belamaf.\n* No prior BCMA-directed therapy.\n* No prior treatment with a monoclonal antibody within 2 weeks of registration.\n* No history of severe allergic reaction (including erythema nodosum) to lenalidomide, pomalidoimide or other prior IMiD therapy.\n* No prior allogeneic stem cell transplant. NOTE: Participants who have undergone syngeneic transplant will be allowed only if no history of or no currently active GvHD.\n* Participant must not have received a live or live-attenuated vaccine within 30 days prior to registration.\n* No plasmapheresis within 7 days prior to registration.\n* Age ≥ 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3.\n* Platelet count ≥ 75,000\u002Fmm\\^3 (or ≥ 50,000\u002Fmm\\^3 in Phase II if bone marrow (BM) plasma cells \\> 50%).\n* Calculated (Calc.) creatinine clearance ≥ 30 mL\u002Fmin using Cockcroft-Gault equation.\n* Spot urine (albumin\u002Fcreatinine ratios) \\\u003C 500 mg\u002Fg (56 mg\u002Fmmol) OR urine dipstick ≥ 1+ if confirmed.\n* Total bilirubin ≤ 2 mg\u002FdL.\n* Aspartate aminotransferase (AST)\u002Falanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN).\n* Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown. FCBP (female of childbearing potential) is a female who: 1) has achieved menarche (first menstrual cycle) at some point, 2) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months). Women of childbearing potential (WOCBP):\n\n  * Must use a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), preferably with low user dependency during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.\n  * The effects of iberdomide on the developing human fetus are unknown. Immunodulatory derivative (IMiD) agents as well as other therapeutic agents used in this trial are known to be teratogenic. Females of child-bearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 10-14 days prior to, and again within 24 hours of starting iberdomide, and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking iberdomide. Examples of highly effective methods are intrauterine device, hormonal contraceptives, tubal ligation, or partner's vasectomy. Examples of barrier method are male condom, diaphragm, or cervical cap. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risk of fetal exposure.\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. FCBP must use adequate contraception for at least 4 months after discontinuation from study. Because of the potential for serious adverse reactions in a breastfed child, women are advised not to breastfeed during treatment and for at least 3 months after the last dose.\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy. Nonchildbearing potential is defined as follows (by other than medical reasons):\n  * ≥ 45 years of age and has not had menses for \\> 1 year\n  * Patients who have been amenorrhoeic for \\\u003C 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n  * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.\n  * Male patients must agree to use an adequate method of contraception for the duration of the study and for 6 months afterwards.\n  * Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies: Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:\n  * Refrain from donating sperm PLUS, either:\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR\n  * Must agree to use contraception\u002Fbarrier as detailed below:\n  * Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C 1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).\n* Archival tissue must be available for submission for the mandatory correlative studies.\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\n  \\* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression.\n* No patients with uncontrolled human immunodeficiency virus (HIV), hepatitis C and B. Testing for HIV and hepatitis C and B are not required prior to registration.\n\n  \\* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* No positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to registration unless the participant can meet the following criteria:\n\n  * RNA test negative.\n  * Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C virus (HCV) RNA test after a washout period of at least 4 weeks.\n* Patients with hepatitis B will be excluded unless the following criteria can be met.\n\n  * Serology: Hepatitis B core antibody positive (HbcAb)+, hepatitis B surface antigen (HbsAg)-.\n  * Screening: Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) undetectable.\n  * During study treatment: Monitoring per protocol.\n  * During study treatment: Antiviral treatment instituted if HBV DNA becomes detectable.\n  * Serology: HBsAg+ at screen or within 3 months prior to registration.\n  * Screening: HBV DNA undetectable.\n  * Screening: Highly effective antiviral treatment started at least 4 weeks prior to first registration.\n  * Screening: Baseline imaging per protocol.\n  * Screening: Participants with cirrhosis are excluded.\n  * During study treatment: Antiviral treatment maintained throughout study treatment.\n  * During study treatment: Monitoring and management per protocol. \\*\\* Note: Presence of isolated hepatitis (Hep) B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.\n* No patients with unacceptable cardiac risk factors defined by any of the following criteria:\n\n  * Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.\n  * History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of Screening.\n  * Class III or IV heart failure as defined by the New York Heart Association functional classification system \\[Error! Reference source not found., 1994\\].\n  * Uncontrolled hypertension.\n  * Patients with congenital long QT syndrome, QTcF interval QTcF \\> 480 msec (the QT interval values must be corrected for heart rate by Fridericia's formula \\[QTcF\\]).\n  * Any history of ventricular fibrillation or torsade de pointes.\n  * Symptomatic bradycardia defined as heart rate (HR) \\\u003C 50 bpm with associated dizziness\u002Fsyncope.\n  * Left ventricular ejection fraction \\\u003C 30%.\n* No patients who have received targeted (non-monoclonal antibodies \\[mAb\\]) or investigational agents within 2 weeks prior to rgistration and who have not recovered from side effects of those therapies.\n* No patients who have undergone major surgery ≤ 2 weeks prior to registration or who have not recovered from the side-effects of surgery.\n* No known medical condition causing an inability to swallow oral formulations of agents.\n* No active bacterial, viral or fungal infection (s) present.\n* Patients cannot have a Child-Pugh score greater than 1 (absent ascites, total bilirubin \\\u003C 2, international normalized ratio (INR) \\\u003C1.7 (unless on anticoagulation), and no encephalopathy; esophageal or gastric varices, and cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.\n* No presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill inclusion criteria.\n* No evidence of active mucosal or internal bleeding.\n* No known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belamaf or drugs chemically related to belamaf, or any of the components of the study treatment.\n* Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or active plasma cell leukemia at the time of screening.\n* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment. Participant must not have current corneal epithelial disease except mild changes in corneal epithelium. For belantamab mafodotin, concomitant administration with strong inhibitors of OATP should be avoided.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Patients must meet criteria for progression of myeloma as defined by IMWG criteria indicated as any of the following:\n\n  * ≥ 25% increase in M-protein (must be at least 0.5 g\u002Fdl above nadir from last treatment regimen).\n  * 25% difference between involved and uninvolved serum free light chains from its nadir or\n  * The development of new plasmacytomas or hypercalcemia not due to other causes. In the absence of progression by serum M protein or free light chain, biopsy of new plasmacytoma of extramedullary disease is warranted.\n  * If refractory myeloma, it should be defined by IMWG criteria as disease which has become non-responsive or progressive on belamaf\u002Fdexamethasone.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Measurable disease defined by IMWG criteria as:\n\n  * Serum M-protein ≥ 0.5 g\u002FdL.\n  * Urine monoclonal protein ≥ 200 mg\u002F24h.\n  * Serum FLC assay: Involved FLC level ≥ 10 mg\u002Fdl (≥ 100 mg\u002Fl) and serum free light chain ratio is abnormal.\n  * PET\u002FCT or MRI findings consistent with (c\u002Fw) disease progression.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Platelet Count ≥ 75,000\u002Fmm\\^3 (or ≥ 50,000\u002Fmm\\^3 if BM plasma cells \\> 50%).\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Calc. creatinine clearance ≥ 30 mL\u002Fmin using Cockcroft-Gault equation.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Total bilirubin ≤ 2 mg\u002FdL.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: AST\u002FALT ≤ 2.5 x upper limit of normal (ULN).\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Alkaline phosphatase ≤ 3 x ULN.",{"count":351,"type":21},88,[353,53],"PHASE1","This phase I\u002FII trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Multiple myeloma is a cancer that affects white blood cells called plasma cells, which are made in the bone marrow and are part of the immune system. Multiple myeloma cells have a protein on their surface called B-cell maturation antigen (BCMA) that allows the cancer cells to survive and grow. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Belantamab mafodotin has been designed to attach to the BCMA protein, which may cause the myeloma cell to become damaged and die. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma.",[356,357],"Recurrent Multiple Myeloma","Refractory Multiple Myeloma",{"date":32,"type":33},{"date":360,"type":33},"2025-04-23",{"date":362,"type":21},"2030-08-01",{"name":39,"class":40},42,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":372,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":375,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":385},"100514305","phase-3-testing-continuous-versus-intermittent-treatment-with-the-study-drug-zanubrutinib-for-older-patients-with-previously-untreated-mantle-cell-lymphoma-100514305","NCT05976763","Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma","A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy With Zanubrutinib as Upfront Treatment in Older Patients With Mantle Cell Lymphoma","Inclusion Criteria:\n\n* • Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and\u002For t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH) as confirmed by the enrolling center\n\n  * Any stage allowed (stage I-IV)\n\n    * Presence of measurable disease, defined as \\>= 1 nodal lesion that is \\> 1.5 cm in longest diameter or \\>= 1 extranodal lesion that is \\> 1 cm in longest diameter\n    * Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg\u002Fday (or equivalent) for up to 7 days\n    * No prior systemic treatment for mantle cell lymphoma\n    * No prior radiation treatment for stage I MCL\n    * No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody\n    * No prior stem cell transplant\n    * Age \\>= 70 years OR age \\>= 60 to \\\u003C 70 years with comorbidities precluding autologous stem cell transplantation (autoSCT) including at least one of the following: a) cardiac ejection fraction (EF) \\\u003C 45%, b) diffusing capacity for carbon monoxide \\\u003C 60% predicted; c) creatinine clearance \\\u003C 70 but \\> 30ml\u002Fminute (min); d) Eastern Cooperative Oncology Group (ECOG) performance status of 2, which poses an unacceptable risk of toxicity for high-dose therapy and stem cell transplantation; or e) Cumulative Illness Rating Scales (CIRS) total score \\> 6\n    * ECOG Performance Status 0-2\n    * Absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3 (without growth factor support within 7 days)\n    * Platelet count \\>= 75,000\u002Fmm\\^3 (or \\>= 50,000\u002Fmm\\^3 for patients with bone marrow involvement of lymphoma) without growth factor support or transfusion within 7 days\n    * Creatinine clearance \\>= 30 mL\u002F min determined by either: a) Estimation using the Cockcroft-Gault equation or b) Measurement by nuclear medicine scan or 24 hour urine collection\n    * Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome)\n    * Aspartate transferase (AST) \u002F alanine transaminase (ALT) =\\\u003C 3 x ULN\n    * Patients should not be considered candidates for stem cell transplant or must have declined a stem cell transplant strategy\n    * No clinically significant cardiovascular disease including the following\n  * Unstable angina within 3 months before registration\n  * New York Heart Association class III or IV congestive heart failure\n  * History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n  * QT correction formula (QTcF) \\> 480 msecs based on Fredericia's formula\n  * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place\n\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    * No active Hepatitis B or Hepatitis C infection. Patients with prior hepatitis B virus (HBV) exposure (positive HBV core antibody and\u002For surface antigen) are eligible if they have no detectable viral load, and are taking appropriate prophylactic antiviral therapy to prevent reactivation. Patients with history of hepatitis C virus (HCV) 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    * No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n    * No history of stroke or intracranial hemorrhage within 6 months prior to registration\n    * No disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. Patient must be able to swallow pills\n    * Potential trial participants should have recovered from major surgery\n    * No vaccination with a live vaccine within 35 days prior to registration\n    * No hypersensitivity to zanubrutinib or rituximab or any of the other ingredients of the study drugs\n    * Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.\n    * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment\n    * Avoid use of moderate CYP3A4 inhibitors, PGP inhibitors, and moderate CYP3A4 inducers\n    * Archival tissue must be available for submission in all patients for histopathology review, though participation in correlative substudies is optional","60 Years",{"count":374,"type":21},421,[24],"This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.",[378],"Mantle Cell Lymphoma",{"date":32,"type":33},{"date":381,"type":33},"2023-10-20",{"date":383,"type":21},"2038-08-31",{"name":39,"class":40},237,{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":407},"100501711","phase-3-pembrolizumab-vs-observation-in-people-with-triple-negative-breast-cancer-who-had-a-pathologic-complete-response-after-chemotherapy-plus-pembrolizumab-100501711","NCT05812807","Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab","OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n* Triple Negative Breast Cancer:\n\n  * Patients with a history of clinical stage T1cN1-2 or T2-4N0-2 (clinical stage II or III prior to preoperative therapy) breast cancer at time of diagnosis according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator in radiologic assessment, clinical assessment or both\n  * Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Isolated tumor cells are considered node-negative\n  * Estrogen receptor (ER) and progesterone receptor (PR) =\\\u003C 10%; HER2-negative by American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines (immunohistochemistry \\[IHC\\] and fluorescence in situ hybridization \\[FISH\\])\n  * If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors\u002Fbreasts\n* Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively\n* An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization\n\n  \\* Note: Adjuvant radiation can be given on study, however, it is recommended to complete adjuvant radiation prior to registration. If radiation is given on study, it is encouraged to be given concurrently with pembrolizumab if the patient is on the pembrolizumab arm, per investigator discretion. Treatment with adjuvant pembrolizumab is strongly discouraged prior to participation in this trial, but if administered (e.g., if patients are awaiting pathology results), pembrolizumab may be administered for up to 6 weeks (i.e., up to 2 q3week doses or up to one q6week dose) post-surgery and must be completed prior to registration post-surgery and must be completed prior to registration\n* Use of investigational anti-cancer agents must be discontinued at time of registration\n* Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows:\n\n  * Breast surgery: Total mastectomy or breast-conserving surgery with histologically negative margins, including no ink on tumor for DCIS, at the time of excision\n\n    \\*\\* For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of ductal carcinoma in-situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates DCIS at the line of resection, additional operative procedures may be performed to obtain clear margins. If DCIS is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection\n  * Lymph node surgery:\n\n    * For a patient with clinically N0 disease, a sentinel lymph node biopsy should have been performed at time of surgical evaluation, and if pathologically node positive, the patient is no longer eligible. Isolated tumor cells are considered node-negative\n    * For a patient with clinically N1 disease at diagnosis (with positive results from a fine-needle aspiration, core biopsy, or sentinel node biopsy performed prior to preoperative therapy) additional surgical evaluation of the axilla following preoperative therapy is required\n\n      \\*\\*\\* If they become cN0 (no palpable adenopathy), then a sentinel lymph node biopsy could have been performed at time of surgery (axillary dissection would also be permitted); if the sentinel lymph node biopsy is positive, the patient is no longer eligible\n    * If sentinel node biopsy performed before preoperative therapy was negative, no additional surgical evaluation of the axilla is required after preoperative therapy. If sentinel node biopsy performed before preoperative therapy was positive, an ALND is required after preoperative therapy\n    * If the only sentinel node identified by isotope scan is in the internal mammary chain, surgical evaluation of the axilla is still required\n    * If sentinel node evaluation after preoperative therapy is negative, no further additional surgical evaluation of the axilla is required\n    * Axillary dissection without sentinel node evaluation is permitted as the initial or sole axillary evaluation after preoperative therapy\n* If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible\n* Not pregnant and not nursing, because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\\\u003C 7 days prior to randomization is required\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3\n* Platelet Count \\>= 100,000\u002Fmm\\^3\n* Estimated glomerular filtration rate (eGFR) \\>= 15 mL\u002Fmin\u002F1.73m\\^2\n* Total Bilirubin =\\\u003C1.5 x upper limit of normal (ULN)\n\n  \\* Patients with Gilbert's disease with a total bilirubin =\\\u003C 2.5 x ULN and direct bilirubin within normal limits are permitted\n* Aspartate aminotransferase (AST) serum aspartate aminotransferase \\[SGOT\\] \u002F alanine aminotransferase (ALT) serum glutamic pyruvic transaminase \\[SGPT\\] =\\\u003C 3 x institutional ULN\n* Patients must be willing to provide tumor tissue from the diagnostic core biopsy. If inadequate tumor tissue is available, patients are still eligible to participate in the trial\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 2B or better\n* Patients with known HIV infection who are on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n\nExclusion Criteria:\n\n* No stage IV (metastatic) breast cancer\n* No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed\n* No evidence of recurrent disease following preoperative therapy and surgery\n* No known active liver disease, e.g. due to hepatitis B virus (HBV), hepatitis C virus (HCV), autoimmune hepatic disorders, or sclerosing cholangitis\n* No history of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any components of the product\n\n  \\* Note: Prior immune-related adverse events (irAEs) are allowed if they resolved to ≤ grade 1 and the patient tolerated subsequent therapy without requiring chronic steroids for the irAE. The following are exceptions to this criterion: Grade 2 or lower immune mediated endocrinopathies due to neoadjuvant checkpoint inhibition but patients are stable on endocrine therapy and were able to continue checkpoint inhibition.\n* No medical conditions that require chronic systemic steroids (\\>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy\n* Patients who are unable or unwilling to comply with the requirements of the protocol per investigator assessment are not eligible",{"count":394,"type":21},1295,[24],"This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive pembrolizumab for up to 27 weeks after surgery. 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. This trial may help researchers determine if observation is as good as receiving pembrolizumab for 27 weeks after surgery in triple-negative breast cancer patients who achieved a pathologic complete response after preoperative treatment with chemotherapy and pembrolizumab.",[287,398,399,400],"Early Stage Triple-Negative Breast Carcinoma","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8",{"date":32,"type":33},{"date":403,"type":33},"2023-06-14",{"date":405,"type":21},"2033-05-31",{"name":39,"class":40},842,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":427},"100490978","phase-3-testing-the-addition-of-total-ablative-therapy-to-usual-systemic-therapy-treatment-for-limited-metastatic-colorectal-cancer-the-erasur-study-100490978","NCT05673148","Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study","A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)","Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma\n* PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor\n* PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation\n* PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and\u002For omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants\n* PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible\n* PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of baseline radiographic imaging obtained prior to initiation of systemic therapy.\n\n  * Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required.\n  * Liver-only metastatic disease is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible for this study.\n  * Metastatic lesions must be amenable to any combination of surgical resection, microwave ablation, and\u002For stereotactic ablative body radiation therapy (SABR). SABR is required for at least one lesion. Therefore, the patient must be seen by a radiation oncologist in consultation to verify eligibility.\n  * Single sites include:\n\n    * Each hemiliver (right and left), each lobe of the lungs, each adrenal gland, lymph nodes amenable to a single resection or treatment in a single SABR field, bone metastases amenable to treatment in a single SABR field\n* PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1\n* PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be administered prior to pre-registration\n* REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration\n* REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined\n* REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1\n* REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks (4 months) and a maximum of 24 weeks (6 months)\n* REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease\n* REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects.\n\n  \\* Therefore, for women of childbearing potential only, a negative pregnancy test done =\\\u003C 14 days prior to registration is required\n* REGISTRATION (STEP 1): Age \\>= 18 years\n* REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2\n* REGISTRATION (STEP 1): Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* REGISTRATION (STEP 1): Platelet count \\>= 50,000\u002Fmm\\^3\n* REGISTRATION (STEP 1): Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \\>= 30 mL\u002Fmin\n\n  \\* Calculated using the Cockcroft-Gault equation\n* REGISTRATION (STEP 1): Total bilirubin =\\\u003C 1.5 x ULN\n* REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x ULN\n\n  \\* In the event of metastatic liver disease, =\\\u003C 5 x ULN\n* REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility\n* REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study\n\nExclusion Criteria:\n\n* N\u002FA",{"count":416,"type":21},364,[24],"This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and\u002For oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and\u002For microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.",[420,164],"Metastatic Colorectal Adenocarcinoma",{"date":32,"type":33},{"date":423,"type":33},"2023-10-09",{"date":425,"type":21},"2032-08-12",{"name":39,"class":40},186,{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":460},"100491312","phase-3-mfolfirinox-versus-mfolfox-with-or-without-nivolumab-for-the-treatment-of-advanced-unresectable-or-metastatic-her2-negative-esophageal-gastroesophageal-junction-and-gastric-adenocarcinoma-100491312","NCT05677490","mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma","Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Bartley et al., Journal of Clinical Oncology \\[JCO\\] 2017) with known PD-L1 CPS (Any CPS is allowed, but should be known prior to registration)\n* Stage: unresectable or metastatic\n* Tumor site: esophagus, gastroesophageal junction, or stomach\n* Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* No prior treatment for unresectable or metastatic disease\n* Prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year prior to registration\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \\>= 30 mL\u002Fmin\n* Total bilirubin =\\\u003C 1.5 x ULN\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x ULN (in patients with liver metastasis: =\\\u003C 5 x ULN if clearly attributable to liver metastases)\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 positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:\n\n  * On effective anti-retroviral therapy\n  * Undetectable HIV viral load by standard clinical assay =\\\u003C 6 months of registration\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patients who will receive nivolumab in addition to chemotherapy must not have any contraindications to immune checkpoint inhibitors\n\n  * Patients must not have active autoimmune disease that has required systemic treatment within 6 months prior to registration. Patients are permitted to receive immunotherapy if they have vitiligo, type I diabetes, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)\n  * Patients must not have a condition requiring systemic treatment with either corticosteroids (\\>10mg\u002Fday prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses (=\\\u003C 10mg\u002Fday prednisone equivalent) are permitted\n  * Patients must not have a history of noninfectious pneumonitis requiring steroids\n  * Patients with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents are ineligible\n* This study includes the use of the mandatory patient completed measure, PRO-CTCAE. For this study the PRO-CTCAE is available in English, Spanish, Korean, Chinese (Simplified), and Russian, hence patients must be able to speak, understand and read in these languages. Ad-hoc translation of patient-reported measures is not permitted\n\nExclusion Criteria:\n\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects\n\n  \\* Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\\\u003C 7 days prior to registration is required\n* No known Gilbert's syndrome or known homozygosity for UGAT1A1\\*28 polymorphism\n* No baseline grade \\>= 2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per CTCAE version (v) 5.0 regardless of causality\n* No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient\n* No untreated, symptomatic brain metastasis. Patients with treated brain metastases are eligible if the following criteria are met: 1) follow-up brain imaging done at least in 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression and 2) the patient no longer requires steroids, or is on a stable steroid dose for more than four weeks\n* No allogeneic tissue\u002Forgan transplant",{"count":342,"type":21},[24],"This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs 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. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.",[439,440,441,442,443,444,445,446,447,448,449,450,451,452,453],"Advanced Esophageal Adenocarcinoma","Advanced Gastric Adenocarcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","Clinical Stage III Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Esophageal Adenocarcinoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Metastatic Esophageal Adenocarcinoma","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Unresectable Esophageal Adenocarcinoma","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma",{"date":32,"type":33},{"date":456,"type":33},"2023-01-31",{"date":458,"type":21},"2028-11-08",{"name":39,"class":40},794,{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":470,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":481},"100488988","phase-2-testing-the-addition-of-immunotherapy-before-surgery-for-patients-with-sarcomatoid-mesothelioma-100488988","NCT05647265","Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma","Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma","Inclusion Criteria:\n\n* Sarcomatoid or sarcomatoid-dominant (\\> 50%) biphasic, pleural mesothelioma\n* Stage: I-IIIA disease per Union for International Cancer Control (UICC) TNM Classification of Malignant Tumours 8th edition\n* Measurable disease or non-measurable disease as defined\n* No prior treatment which would be considered treatment for the primary neoplasm or impact the primary endpoint\n* No treatment with hormones or other chemotherapeutic agents except for hormones administered for non-disease-related conditions (e.g., insulin for diabetes and or hormonal therapy for breast, prostate cancer etc.)\n* Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown\n\n  \\* Therefore, for women of childbearing potential only, a negative pregnancy test done =\\\u003C 14 days prior to registration is required\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 or Karnofsky \\>= 60%\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3\n* Leukocytes \\>= 2,000\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR creatinine clearance \\>= 40 mL\u002Fmin\n* Total bilirubin =\\\u003C1.5 x ULN, except patients with Gilbert Syndrome who can have total bilirubin \\\u003C 3.0 mg\u002Fdl\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3.0 x ULN\n* Alkaline (alk) phosphatase (phos) =\\\u003C 3.0 x ULN\n* No active, known or suspected autoimmune disease except for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger\n* No active systemic infection requiring therapy, as well as positive tests for hepatitis B surface antigen or hepatitis C antibody\n* No history of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNFalpha) therapies or other immunosuppressant medications during the study\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* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* 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* STEP 2 ELIGIBILITY CRITERIA: Completion of at least 1 cycle of treatment and not have an unresolved adverse event that would preclude surgery\n* STEP 2 ELIGIBILITY CRITERIA: No evidence of progression that would preclude resection\n* STEP 2 ELIGIBILITY CRITERIA: ECOG performance status =\\\u003C 2 or Karnofsky \\>= 60%\n* STEP 2 ELIGIBILITY CRITERIA: Predicted forced expiratory volume in 1 second (FEV1) \\> 35% and postoperative predicted diffusion capacity of the lung for carbon monoxide (DLCO) \\> 35%\n* STEP 2 ELIGIBILITY CRITERIA: Registration to step 2 no less than 21 days and no more than 90 days after the last dose of neoadjuvant therapy\n\nExclusion Criteria:\n\n* No patients deemed to be unresectable or poor surgical candidates\n* No patients with chest wall invasion, peritoneal spread, contralateral pleural involvement, mediastinal organ involvement, vertebral involvement, or metastases to contralateral intrathoracic lymph nodes, or any supraclavicular nodes\n* No patients with a history of symptomatic interstitial lung disease",{"count":469,"type":21},26,[53],"This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.",[473,474],"Pleural Biphasic Mesothelioma","Pleural Sarcomatoid Mesothelioma",{"date":32,"type":33},{"date":477,"type":33},"2024-11-27",{"date":479,"type":21},"2026-12-15",{"name":39,"class":40},132,{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":71,"sex":17,"minAge":489,"maxAge":490,"enrollmentInfo":491,"targetDuration":4,"studyType":493,"phases":4,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":562},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928","NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages","40 Years","75 Years",{"count":492,"type":21},2000,"OBSERVATIONAL","This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[496,497,498,499,500,501,27,502,503,504,505,506,507,508,509,510,511,512,513,514,224,515,516,517,518,519,520,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Myeloid Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma",{"date":32,"type":33},{"date":558,"type":33},"2022-08-18",{"date":560,"type":21},"2027-02-28",{"name":39,"class":40},745,{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":582},"100439942","phase-3-reaching-rural-cancer-survivors-who-smoke-using-text-based-program-100439942","NCT05008848","Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program","Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions","Inclusion Criteria:\n\n* Have a cancer diagnosis within the past 10 years, and can currently be receiving curative treatment\n* Not currently on hospice\n* Currently smokes \\>= 5 cigarettes daily\n* Lives in a nonmetro\u002Frural county (defined as having a Rural Urban Continuum Code \\[RUCC\\] code of 4-9)\n* Patient interested in participating in a smoking cessation program, and not currently participating in a smoking cessation clinical trial\n* Not currently using any smoking cessation pharmacotherapy (e.g. nicotine replacement therapy, bupropion or varenicline), or currently participating in any cessation program\n* Patient has a cell phone or smart phone device with texting ability\n* In order to complete the mandatory patient-completed measures, participants must be able to speak and read English\n* Age \\>= 18 years\n* Participant must be willing to provide a urine sample.\n\nExclusion Criteria:\n\n* Psychiatric illness which would prevent the patient from giving informed consent\n* Patients with impaired decision-making capacity are not eligible for this study.",{"count":571,"type":21},600,[24],"This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking.",[575],"Cigarette Smoking-Related Carcinoma",{"date":32,"type":33},{"date":578,"type":33},"2022-04-01",{"date":580,"type":21},"2027-08-01",{"name":39,"class":40},222,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":493,"phases":4,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":601},"100381092","collection-of-research-data-and-samples-from-patients-who-experience-immunotherapy-side-effects-100381092","NCT04242095","Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects","Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events","Inclusion Criteria:\n\n* Received a regimen containing one or more immuno-oncology therapeutics\n* Must have experienced one or more of the following:\n\n  * One or more serious (Grade 3-4) AEs that are likely immune-related\n  * One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related\n  * Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment\n\n    \\*\\* Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded\n  * Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review\n  * Has not previously been registered to this study",{"count":591,"type":21},240,"This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.",[594],"Malignancy",{"date":32,"type":33},{"date":597,"type":33},"2020-03-12",{"date":599,"type":21},"2026-10-01",{"name":39,"class":40},625,{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":622},"100297337","phase-3-inotuzumab-ozogamicin-and-frontline-chemotherapy-in-treating-young-adults-with-newly-diagnosed-b-acute-lymphoblastic-leukemia-100297337","NCT03150693","Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia","A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL","Inclusion Criteria:\n\nREGISTRATION ELIGIBILITY CRITERIA (STEP 1)\n\n* Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; systemic chemotherapy must begin within 72 hours of this intrathecal therapy\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age \\>= 18 years and \\\u003C 40 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\\\u003C 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Direct bilirubin =\\\u003C 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Calculated (calc.) creatinine clearance \\>= 50 mL\u002Fmin by Cockcroft-Gault\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Completion of remission induction therapy\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY):Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized\n\n  * Rating: M0, M1; Blast Cells (%): 0-5.0\n  * Rating: M2; Blast Cells (%): 5.1-25.0\n  * Rating: M3; Blast Cells (%): \\> 25-50\n  * Rating: M4; Blast Cells (%): \\> 50.0\n  * The term \"blast cell\" includes any cell that cannot be classified as a more mature normal element, and includes \"leukemic cells,\" pathologic lymphocytes, and stem cells\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Platelet count \\>= 75,000\u002Fmm\\^3\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Aspartate aminotransferase (AST) =\\\u003C 8 x upper limit of normal (ULN)\n\nEXCLUSION CRITERIA\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: patients must also be assessed for CD20 positivity and other markers; positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for ALL except for limited treatment (=\\\u003C 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\\\u003C 8 days prior to registration is required\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with down syndrome are excluded from this study due to the likelihood of excessive toxicity resulting; these patients should be treated in consultation with a pediatric oncologist","39 Years",{"count":611,"type":21},303,[24],"This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as \\[intervention\\], 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. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.",[615],"B Acute Lymphoblastic Leukemia",{"date":32,"type":33},{"date":618,"type":33},"2017-09-20",{"date":620,"type":21},"2027-08",{"name":39,"class":40},460,{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":22,"phases":632,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":644},"100249231","phase-2-vismodegib-fak-inhibitor-gsk2256098-capivasertib-and-abemaciclib-in-treating-patients-with-progressive-meningiomas-100249231","NCT02523014","Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas","Phase II Trial of SMO\u002F AKT\u002F NF2\u002FCDK Inhibitors in Progressive Meningiomas With SMO\u002F AKT\u002F NF2\u002FCDK Pathway Mutations","* Documentation of disease:\n\n  * Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review\n  * Molecular documentation: Presence of SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN mutations, CDKN2A copy number loss, CDK4, CDK6, CCND1, CCND2, CCND3, or CCNE1 copy number gain in tumor sample as documented specifically by the central laboratory, regardless of whether prior genotype testing outside of the central laboratory was performed\n  * Progressive OR residual disease, as defined by the following:\n\n    * Residual measurable disease: residual measurable disease immediately after surgery without requirement for progression; for grade I disease, progression pre-operatively needs to be documented, with an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months; for patients with SMO\u002FPTCH1 mutations enrolling to receive vismodegib, the change can occur between scans separated by up to 25 months; residual measurable disease will be defined by bidimensionally measurable lesions with clearly defined margins by MRI scans, with a minimum diameter of 10 mm in both dimensions\n    * Progressive measurable disease: progression defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months\n    * Post radiation patients: patients with measurable and progressive meningioma who have received radiation are potentially eligible, but need to show evidence of progressive disease after completion of radiation; if the progressive meningioma lesion has been radiated, at least 24 weeks must have elapsed from completion of radiation to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration\n* Measurable disease: measurable disease is defined by a bidimensionally measurable main lesion on MRI or computed tomography (CT) images (MRI preferred) with clearly defined margins and a minimum diameter of 10 mm in both dimensions; multifocal disease is allowed\n* Prior treatment\n\n  * Prior medical therapy is allowed but not required\n  * No limit on number of prior therapies\n  * No chemotherapy, or other investigational agents within 28 days prior to registration\n  * No other concurrent investigational agents or other meningioma-directed therapy (chemotherapy, radiation) while on study; additionally, no cases of nitrosourea or mitomycin C within 6 weeks prior to registration\n  * For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval \\> 4 weeks must have elapsed from completion of radiation therapy to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration\n  * Steroid dosing stable for at least 4 days\n  * Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia and fatigue\n  * No craniotomy 28 days prior to and after registration\n* Not pregnant and not nursing:\n\n  \\* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* For patients with NF2\u002FCDKN2A\u002FAKT1\u002FPIK3CA\u002FPTEN mutation, CKDN2A copy number loss, or CDK4\u002FCDK6\u002FCCND1\u002FCCND2\u002FCCND3\u002FCCNE1 copy number gain: Age \\>= 18 years\n* For patients with SMO\u002FPTCH1 mutation: Age \\>= 30 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Patient history:\n\n  * Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months\n  * No metastatic meningiomas (as defined by extracranial meningiomas outside of CNS) allowed; spinal meningiomas are allowed\n  * No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug\n  * No known active hepatitis B or C\n  * No current Child Pugh class B or C liver disease\n  * No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease within 28 days of registration)\n  * No uncontrolled hypertension defined as blood pressure (BP) \\> 140\u002F90\n  * No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 28 days prior to registration\n  * No major surgery within 28 days prior to registration for any patients with AKT1\u002FPIK3CA\u002FPTEN mutations receiving capivasertib\n  * For patients going on to receive capivasertib (i.e. enrolled after Update #08)\n\n    * Patients should not have any of the following cardiac criteria:\n\n      * Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (EKG) (e.g., complete left bundle branch block, third degree heart block)\n      * Any factors that increase the risk of corrected QT (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, potential for Torsade de Pointes, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval\n      * Experience any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) class \\>= II\n      * Uncontrolled hypertension (systolic blood pressure \\[SBP\\] \\\u003C 90 mmHg and\u002For diastolic blood pressure \\[DBP\\] \\\u003C 50 mmHg)\n      * Cardiac ejection fraction outside institutional range of normal or \\\u003C 50% (whichever is higher) as measured by echocardiogram (or multigated acquisition \\[MUGA\\] scan if an echocardiogram can't be performed or is inconclusive); left ventricular ejection fraction (LVEF) below lower limit of normal for site\n    * Patients should not have any of the following criteria:\n\n      * With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of registration\n      * Hemoglobin \\\u003C 9 g\u002FdL (\\\u003C 5.59 mmol\u002FL); note: any blood transfusion must be \\>= 14 days prior to the determination of a hemoglobin \\>= 9 g\u002FdL (\\>= 5.59 mmol\u002FL)\n      * Proteinuria 3+ on dipstick analysis or \\> 500 mg\u002F24 hours\n      * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of capivasertib\n      * History of hypersensitivity to active or inactive excipients of capivasertib or drugs with a similar chemical structure or class to capivasertib\n      * Current disease or condition known to interfere with absorption, distribution, metabolism, or excretion of drugs\n      * Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\n      * Previous allogeneic bone marrow transplant\n      * Known immunodeficiency syndrome\n* Concomitant medications (only regarding NF2\u002FCDKN2A\u002FCDK4\u002FCDK6\u002FCCND1\u002FCCND2\u002FCCND3\u002FCCNE1\u002FAKT1\u002FPIK3CA\u002FPTEN genetic alterations):\n\n  * Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098, as well as for patients with AKT1\u002FPIK3CA\u002FPTEN mutations enrolled to capivasertib\n  * For NF2 patients going on to receive GSK2256098 and for patients with AKT1\u002FPIK3CA\u002FPTEN mutations enrolled to capivasertib: concomitant treatment with strong CYP3A4 inducers or CYP2D6 substrates is not allowed; patients must discontinue the drug 14 days prior to registration\n  * For NF2 patients going on to receive abemaciclib: avoid concomitant use of CYP3A inducers and strong CYP3A inhibitors; use caution with coadministered moderate or weak CYP3A inhibitors\n* Diabetic status:\n\n  * For patients with NF2 or SMO\u002FPTCH1 mutations: No uncontrolled diabetes defined as a known diabetic with HBA1C \\> 7.5 OR fasting glucose \\> 140 mg\u002FdL.\n  * For patients with AKT1\u002FPIK3CA\u002FPTEN mutations:\n\n    * Glycosylated hemoglobin (HbA1C) \\\u003C 8.0% (63.9 mmol\u002Fmol)\n    * No type 1 diabetes mellitus\n    * No requirement for insulin for routine diabetic management and control\n    * No requirement for more than two oral hypoglycemic medications for routine diabetic management and control\n    * Patients with a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose \\\u003C 9.3 mmol\u002FL (167mg\u002FdL); fasting is defined as no caloric intake for at least 8 hours\n  * Patients without a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose =\\\u003C 7.0 mmol\u002FL (126 mg\u002FdL); fasting is defined as no caloric intake for at least 8 hours\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Creatinine OR =\\\u003C 1.5 mg\u002Fdl x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \\> 50 mL\u002Fmin\n* Urine protein:creatinine ratio (UPC) =\\\u003C 45 mg\u002Fmmol\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN); except in case of Gilbert's disease\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Sodium, potassium, total calcium (corrected for serum albumin) \\& phosphorus within normal limits per institutional guidelines\n* QTcF \\\u003C 450 msec (QT calculated using Fridericia formula)\n* Mean resting heart rate (determined from EKG) 50-100 beats per minute (BMP) (must be obtained from 12-lead EKG defined by a triplicate EKG for patients assigned to the capivasertib arm; patients assigned to all other arms will require a single EKG\n* No uncontrolled medical comorbidities per investigator discretion (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or pre-existing Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)\n* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Hemoglobin \\>= 8 g\u002FdL\n\n  \\* Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; initial treatment must not begin earlier than the day after the erythrocyte transfusion\n* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Prior Treatment\n\n  * Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade =\\\u003C 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to registration; a washout period of at least 28 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy)\n  * Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy; a washout period of at least 28 days is required between end of radiotherapy and registration\n* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No active bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]); screening is not required for enrollment in the absence of symptoms\n* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest",{"count":631,"type":21},124,[53],"This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.",[635,636,637],"Intracranial Meningioma","Recurrent Meningioma","NF2 Gene Mutation",{"date":32,"type":33},{"date":640,"type":33},"2015-09-28",{"date":642,"type":21},"2028-01",{"name":39,"class":40},780,{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":22,"phases":655,"briefSummary":656,"conditions":657,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":667},"100564730","phase-2-targeted-treatment-for-metastatic-prostate-cancer-the-predict-trial-100564730","NCT06632977","Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial","PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)","PREDICT","Inclusion Criteria:\n\n* PRE-REGISTRATION: Histological or cytological evidence of prostate cancer. Patients with variant histologies including neuroendocrine, small cell and sarcomatoid prostate cancer are allowed to enroll and these will not be used as selection criteria for individual arms. Central pathology review is not required.\n* PRE-REGISTRATION: Measurable disease and\u002For non-measurable metastatic disease per RECIST version 1.1.\n* PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available for submission per Section 6.2. For patients who have progressed on A032102 and are pre-registering again, repeat tissue procurement will not be mandated.\n* PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned based on pre-determined qualifying molecular\u002FDNA alterations as stated in Section 4.8 after receipt of local molecular testing by the A032102 molecular tumor board (MTB). Final determination of arm assignment will be determined by the MTB. For qualifying DNA alteration determined by the MTB, testing may be from tumor tissue collected at any time or circulating tumor DNA (ctDNA) within 12 months of pre-registration. If no qualifying DNA alteration is identified based on the CLIA-certified next generation sequencing assay and MTB review, Caris testing, should be performed for both DNA\u002FRNA profiling. Arm assignment based RNA requires testing of tumor tissue collected within 12 months of pre-registration and MTB review.\n* PRE-REGISTRATION: Age ≥ 18 years.\n* REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone \\< 50 ng\u002FdL AND one or more of the following criteria (choose all the apply):\n\n  * PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng\u002FmL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy.\n  * Radiographic progression per RECIST 1.1 criteria for soft tissue lesions\n  * Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.\n* REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For reference, in the VISION trial this was defined as at least 1 PSMA+ metastatic lesion (defined as uptake greater than that of liver parenchyma in lesions of any size in any organ system) and no PSMA- lesions (defined as uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any solid organ lesion with a short axis of at least 1.0 cm, or in any bone lesion with a soft-tissue component of at least 1.0 cm in the short axis).\n* REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy. Prior lutetium LU177 vipivotide tetraxetan treatment is permitted but not mandated. Patients with known germline or somatic deleterious BRCA 1\u002F2 mutations must have received a prior PARPi.\n* REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \\> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:\n\n  * Chemotherapy-induced neuropathy\n  * Fatigue\n  * Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism\u002Fhyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)\n* REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitor) within 2 weeks of registration. Treatment with abiraterone acetate, apalutamide, or darolutamide within 2 weeks of registration. Treatment with enzalutamide within 4 weeks of registration. No treatment with radiation therapy within 2 weeks of registration.\n* REGISTRATION: No major surgery within 4 weeks of registration.\n* REGISTRATION: No prior treatment with EZH inhibitors.\n* REGISTRATION: Prior treatment with cabazitaxel + carboplatin.\n* REGISTRATION: None of the following conditions:\n\n  * Current use of moderate or strong cytochrome P450 (CYP)3A inducers.\n  * Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients.\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\n  \\* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n  * Imminent or established spinal cord compression based on clinical and\u002For imaging findings.\n  * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before registration.\n  * Significant cardiovascular defined as:\n  * Myocardial infarction within 6 months prior to enrollment.\n  * Uncontrolled angina pectoris within 6 months prior to enrollment.\n  * New York Heart Association Class 3 or 4 congestive heart failure.\n  * Corrected QT interval calculated by the Fridericia\\'s formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. Patients with known history or current symptoms of cardiac disease, history of treatment with cardiotoxic agents, or agents\u002Fconditions known to impact QTcF should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and ECG.\n  * Uncontrolled hypertension (resting systolic blood pressure \\>160 mmHg or diastolic blood pressure \\> 100 mmHg).\n  * Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy.\n  * Moderate to severe hepatic impairment (Child-Pugh Class C)\n* REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration.\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration.\n* REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration.\n* REGISTRATION: No platelet transfusions within 2 weeks of registration.\n* REGISTRATION: No bleeding diathesis.\n* REGISTRATION: White blood cell count (WBC) ≥ 2,500\u002FmcL.\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL.\n* REGISTRATION: Hemoglobin ≥ 9 g\u002FdL.\n* REGISTRATION: Platelet count ≥ 100,000\u002FmcL.\n* REGISTRATION: Creatinine clearance ≥ 30 mL\u002Fmin as defined by Cockcroft-Gault equation.\n* REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal \\[ULN\\] for subjects with documented Gilbert\\'s disease).\n* REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.\n* REGISTRATION: Albumin ≥ 2.8 g\u002FdL.\n* REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration\u002Frandomization office will relay the assignment to the submitting site. Once the site receives this assignment, they can register the patient to A032102. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.\n* RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone \\< 50 ng\u002FdL AND 2) progressive disease defined by radiographic progression on conventional imaging (CT\u002FMRI chest, abdomen and pelvis and bone scan within 42 days of re-registration).\n* RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \\> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:\n\n  * Chemotherapy-induced neuropathy\n  * Fatigue\n  * Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism\u002Fhyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo).\n* RE-REGISTRATION: None of the following conditions:\n\n  * Imminent or established spinal cord compression based on clinical and\u002For imaging findings.\n  * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to re-registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before re-registration.\n  * Corrected QT interval calculated by the Fridericia\\'s formula (QTcF) \\< 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF.\n  * Significant cardiovascular defined as:\n  * Myocardial infarction within 6 months prior to enrollment.\n  * Uncontrolled angina pectoris within 6 months prior to enrollment.\n  * New York Heart Association Class 3 or 4 congestive heart failure.\n  * Uncontrolled hypertension (resting systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg).\n* RE-REGISTRATION: ECOG Performance Status 0-2.\n* RE-REGISTRATION: No GCSF within 2 weeks of registration.\n* RE-REGISTRATION: No RBC transfusions within 2 weeks of registration.\n* RE-REGISTRATION: No platelet transfusions within 2 weeks of registration.\n* RE-REGISTRATION: WBC ≥ 2,500\u002FmcL.\n* RE-REGISTRATION: ANC ≥ 1,500\u002FmcL.\n* RE-REGISTRATION: Hemoglobin ≥ 9 g\u002FdL (transfusions permitted).\n* RE-REGISTRATION: Platelet count ≥ 100,000\u002FmcL.\n* RE-REGISTRATION: Creatinine clearance ≥ 30 mL\u002Fmin as defined by Cockcroft-Gault equation.\n* RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert\\'s disease).\n* RE-REGISTRATION: AST and ALT ≤ 3 x ULN.\n* RE-REGISTRATION: Albumin ≥ 2.8 g\u002FdL.\n* RE-REGISTRATION: QT Interval (QTcF) \\< 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF).\n* RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration\u002Frandomization office will relay the assignment to the site. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.\n\nExclusion Criteria:\n\n\\-",{"count":654,"type":21},474,[53],"This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1\u002FEZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. 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 tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing",[658,131],"Castration-Resistant Prostate Carcinoma","2026-06-01",{"date":661,"type":33},"2026-06-02",{"date":663,"type":33},"2025-02-06",{"date":665,"type":21},"2034-10-11",{"name":39,"class":40},107,""]