[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovarian-germ-cell-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovarian-germ-cell-tumor":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100537335","phase-1-phase-1-safety-and-tolerability-study-of-xmab541-in-advanced-solid-tumors-100537335",false,"NCT06276491","Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors","A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥ 18 years. For US only: subjects with GCTs, age ≥15 years\n* CLDN6+ tumor\n* Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT resistant to previous treatment\n* Adequate Eastern Cooperative Oncology Group performance status\n* Life expectancy ≥ 3 months\n* Adequate liver, kidney, and bone marrow function\n\nKey Exclusion Criteria:\n\n* Patients with treated brain metastases may participate, provided they are radiologically stable.\n* Active known or suspected autoimmune disease\n* Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug\n* Clinically significant cardiovascular, pulmonary or gastrointestinal disease\n* Active hepatitis B or hepatitis C","ALL","15 Years",{"count":19,"type":20},282,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.",[26,27,28,29,30],"Ovarian Cancer","Endometrial Cancer","Germ Cell Tumor","Testicular Germ Cell Tumor","Ovarian Germ Cell Tumor",[32,26,33,34,28,27,35],"Phase 1","CLDN6","Testicular Cancer","T-cell Engager","RECRUITING","2026-06-09",{"date":39,"type":40},"2026-06-11","ACTUAL",{"date":42,"type":40},"2024-04-04",{"date":44,"type":20},"2028-12",{"name":46,"class":47},"Xencor, Inc.","INDUSTRY",18,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":71,"locationsCount":74},"100424216","phase-2-maintenance-oral-etoposide-or-observation-following-high-dose-chemo-for-gct-100424216","NCT04804007","Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT","Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information\n2. Age ≥ 18 years at the time of consent\n3. Histological or serological evidence of non-seminomatous GCT\n4. Relapsed disease after first-line cisplatin-based combination chemotherapy\n5. Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines\n6. HDCT must have been used as the initial salvage chemotherapy regimen (2nd line therapy) 6.1. Note: 1 or 2 cycles of standard course regimens prior to HDCT are acceptable (regimens include VeIP \\[vinblastine+ifosfmaide+cisplatin\\] or TIP \\[paclitaxel+ifosfamide+cisplatin\\] or PVB \\[cisplatin+vinblastine+bleomycin\\]\n7. Normal or declining tumor markers (AFP and hCG) at time of screening\n8. Adverse events from prior therapy recovered to CTCAE v5.0 grade ≤ 2 at time of registration\n9. Women with ovarian germ cell tumors are eligible\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 28 days of study registration\n11. Last dose of HDCT must be ≤16 weeks from study registration\n12. Adequate organ function lab values obtained within 28 days prior to study registration System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,000 \u002FmcL Platelets ≥100,000 \u002F mcL Hemoglobin ≥8 g\u002FdL Renal Serum creatinine \\\u003C2mg\u002FdL Hepatic Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n\n    AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR\n    * 5 X ULN for subjects with liver metastases Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n13. If a female of childbearing potential, a negative urine pregnancy test within 28 days prior to receiving the first dose of study drug.\n\n    o Non-childbearing potential is defined as (by other than medical reasons):\n    * ≥ 45 years of age and has not had menses for \\>2 years\n    * Amenorrheic for \\\u003C 2 years without a hysterectomy and\u002For oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation\n    * Post hysterectomy or oophorectomy. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound.\n14. For female patients of childbearing potential and male patients, agreement (by patient and\u002For partner) to use two forms of highly effective contraception (i.e., one that results in a low failure rate \\[\\\u003C 1% per year\\] when used consistently and correctly) starting with the first dose of study therapy and to continue its use for 30 days after the last dose of study therapy, or abstain from heterosexual activity.\n\nExclusion Criteria:\n\n1. Relapsed pure seminoma\n2. Rising tumor markers (AFP and hCG) at time of screening\n3. Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) \\>16 weeks ago\n4. Treatment with any investigational agent within 28 days prior to study registration\n5. Other active malignancy requiring treatment in past 12 months\n6. History of psychiatric illness or social situations that would limit compliance with study requirements\n7. Active infection requiring systemic therapy\n8. Previous hypersensitivity to etoposide which did not recover with supportive care\n9. Pregnancy, lactation, or breastfeeding\n10. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.","18 Years",{"count":58,"type":20},64,[60],"PHASE2","This is an open label randomized phase II trial of maintenance oral etoposide vs. observation in patinets with relapsed GCT treated with high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplant (PBSCT).",[28,63,30],"Non-seminomatous Germ Cell Tumor",[28],"2026-05-05",{"date":67,"type":40},"2026-05-08",{"date":69,"type":40},"2021-03-03",{"date":44,"type":20},{"name":72,"class":73},"Nabil Adra","OTHER",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":5},"100477701","phase-2-assessment-of-compliance-with-monitoring-conducted-by-a-physician-in-person-or-by-a-nurse-in-remote-monitoring-100477701","NCT05500391","Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring","Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring","SUR-CAN","Inclusion Criteria:\n\n* Positive diagnosis (anatomopathology) of tumor within 12 months\n* Patient 18 years of age or older\n* Patient with one of the following conditions:\n\n  1. Desmoid fibromatosis of the abdominal wall operated on or under active surveillance\n  2. Stage I testicular seminoma (whether or not treated with carboplatin AUC7)\n  3. Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy)\n  4. Operated GIST with low risk of relapse\n  5. Rare gynecological tumors (sex cord and stromal tumors; germ cell tumors of the ovary, clear cell adenocarcinoma, mucinous adenocarcinoma of the ovary, borderline tumors, small cell carcinoma, ovarian and uterine carcinosarcoma, low grade serous tumors), operated\n  6. Low-grade glioma, operated\n  7. Low-grade neuroendocrine tumor, treated by surgery alone\n* Patient who has given consent to participate in the study\n\nExclusion Criteria:\n\n* Contraindication to imaging tests required for the surveillance plan\n* No telephone\n* Patient under guardianship or curatorship",{"count":84,"type":20},88,[60],"This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\\\u003C12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).",[88,89,90,30,91,92,93,94,95,96,97,98,99,100],"Stage I Testicular Seminoma","Stage I Testicular Nonseminomatous Germ Cell Tumor","Gastrointestinal Stromal Tumors","Adenocarcinoma, Clear Cell","Borderline Ovarian Tumor","Sex Cord-Stromal Tumor","Mucinous Adenocarcinoma of Ovary","Carcinoma, Small Cell","Carcinosarcoma, Ovarian","Serous Tumor of Ovary","Glioma","Neuroendocrine Tumors","Aggressive Fibromatosis of Abdominal Wall (Disorder)","2026-03-16",{"date":103,"type":40},"2026-03-18",{"date":105,"type":40},"2024-02-28",{"date":107,"type":20},"2032-07",{"name":109,"class":73},"Centre Oscar Lambret"]