[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fallopian-tube-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fallopian-tube-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,51,0,25,[9,44,87,115,135,162,181,204,229,259,280,290,314,344,365,412,439,464,491,536,555,597,621,655,673],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053788","phase-2-an-evaluation-of-maintenance-therapy-combination-mirvetuximab-soravtansine-and-olaparib-100053788",false,"NCT05887609","An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib","A Phase II Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine-gynx and Olaparib in Recurrent Platinum Sensitive Ovarian, Peritoneal, and Fallopian Tube Cancer","Inclusion Criteria:\n\n* Provision to sign and date the consent form\n* Stated willingness to comply with all study procedures and be available for the duration of the study\n* Be a woman aged ≥18 years of age\n* Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n* Patients must have a confirmed diagnosis of high-grade serous or endometrioid EOC, primary peritoneal cancer, or fallopian tube cancer\n* Patients must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of prior platinum therapy (not inclusive of current\u002Fmost recent platinum therapy)\n* Patients must have had documented complete or partial response, or stable disease, as defined by RECIST 1.1, from last line of platinum therapy\n* Patients must have available archival tissue block or slides to confirm FRalpha positivity\n* Patients' tumor must have FRalpha high or medium expression\n* Prior anticancer therapy:\n\n  * Patients must have received at least one prior platinum-based chemotherapy regimen for platinum sensitive recurrent disease.\n  * Most recent prior chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles\n  * Most recent prior chemotherapy regimen must have been platinum based\n  * Patients must have had testing for BRCA mutation (tumor or germline) and, if positive, must have received a prior PARP inhibitor as either treatment or maintenance therapy\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy\n  * Maintenance therapy (eg, Bevacizumab, PARP inhibitors) will be considered part of preceding line of therapy (ie, not counted independently)\n  * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)\n  * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance\n  * Prior Bevacizumab use is allowed, but concurrent use with study combination is prohibited.\n  * Cycle 1 Day 1 of trial therapy must be within 8 weeks of last dose of previous chemotherapy.\n* Patients must have adequate hematologic, liver, and kidney function as defined as:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1500\u002FµL)\n  * Platelet count ≥ 100 x 109\u002FL (100,000 µL)\n  * Hemoglobin ≥ 10.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n  * Patients must have creatinine clearance estimated of ≥51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test\n  * Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN\n  * Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \\\u003C 3.0 x ULN)\n  * Serum albumin ≥ 2 g\u002FdL\n\nExclusion Criteria:\n\n* Patients with clear cell, mucinous, sarcomatous, low grade\u002Fborderline, germ cell, or sex-cord stromal type ovarian tumor\n* Patients who have progressed through most recent chemotherapy regimen. Stable disease (SD) is permissible.\n* Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment\n* Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions require ongoing treatment\u002Fmonitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and\u002For monocular vision\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of MDS\u002FAML.\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to:\n\n  * Uncontrolled major seizure disorder\n  * Unstable spinal cord compression\n  * Any psychiatric disorder that prohibits obtaining informed consent.\n  * Active hepatitis B or C infection (whether or not on active antiviral therapy)\n  * Immunocompromised patients, e.g., patient who are known to be serologically positive for human immunodeficient virus(HIV)\n  * Active cytomegalovirus infection\n  * Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV\n* Patients with a history of multiple sclerosis (MS) or other demyelinating disease and\u002For Lambert-Eaton syndrome (paraneoplastic syndrome)\n* Patients with clinically significant cardiac disease including, but not limited to, any of the following\n\n  * Myocardial infarction ≤ 6 months prior to first dose\n  * Uncontrolled ventricular arrhythmia, recent (within 3 months)\n  * Superior vena cava syndrome\n  * Unstable angina pectoris\n  * Uncontrolled congestive heart failure (New York Heart Association \\> class II)\n  * Uncontrolled ≥ Grade 3 hypertension (per CTCAE)\n  * Uncontrolled cardiac arrhythmias\n* Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment\n* Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)\n* Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD) or Extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan , including noninfectious pneumonitis\n* Persistent toxicities (\\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia\n* Patients requiring use of folate-containing supplements (eg, folate deficiency)\n* Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.\n* Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n* Patients with prior hypersensitivity to monoclonal antibodies (mAb)\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n* Women who are pregnant or breastfeeding, and who do not agree to use a highly effective contraceptive method(s) while on study drug and for at least 3 months after the last dose of MIRV and at least 6 months after the last dose of Olaparib. Females of childbearing potential must have a negative serum pregnancy test within 72 hours of study entry.\n* Patients who received prior treatment with MIRV or other FRα- targeting agents\n* Patients with duodenal stent or other GI disorder\u002Fdefect that would interfere with absorption of oral medication\n\n  * Includes patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n* Patients with known untreated or symptomatic central nervous system (CNS) metastases\n* Patients with a history of other malignancy within 3 years prior to enrollment\n\n  * Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible\n* Prior known hypersensitivity reaction to study drugs and\u002For any of their excipients\n* Minor or major surgical procedure within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n* Inability to comply with study and follow-up procedures\n* Patients deemed otherwise clinically unfit for clinical trial per investigators discretion","FEMALE","18 Years","100 Years",{"count":21,"type":22},53,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.",[28,29,30],"Ovary Cancer","Peritoneal Cancer","Fallopian Tube Cancer","RECRUITING","2026-07-09",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2023-10-03",{"date":39,"type":22},"2031-01-31",{"name":41,"class":42},"University of Colorado, Denver","OTHER",6,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":70,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100472291","a-study-comparing-perioperative-stress-reduction-vs-standard-of-care-in-ovarian-cancer-preserve-100472291","NCT05429970","A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)","Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study","Inclusion Criteria:\n\n* Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, CA125, and clinical assessment\n* Scheduled to undergo exploratory laparotomy and PDS or IDS\n* Scheduled for surgery with at least 10 days of lead time, to allow the participant to take the β-blocker and COX2 inhibitor 7 days preoperatively\n* Age ≥18 years\n* ASA score of 1 to 3\n* Ability to understand the study objectives and procedures, comply with the protocol, and provide informed consent\n\nExclusion Criteria:\n\n* Chronic treatment with any β-blocker or COX inhibitor\n* Contraindication for β-blocker therapy (asthma, second- or third-degree atrioventricular block, sinus bradycardia, sick sinus syndrome, right-sided heart failure, pheochromocytoma, peripheral vascular disease)\n* Contraindication for COX2 inhibitor therapy (renal failure \\[creatinine level \\>1.5 mg\u002FdL\\], significant liver failure \\[known cirrhosis, bilirubin level \\>2\\], active peptic disease), or current use of oral anticoagulant)\n* Contraindication for regional epidural anesthesia\n* Chronic autoimmune disease\n* Active infection\n* Pregnant\n* Minimally invasive procedure\n* Participation in another clinical trial that interferes with this study",{"count":52,"type":22},35,[54],"NA","The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training\u002FMBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery\u002FPDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).",[57,58,59,60,61,62,63,64,65,30,66,67,68,69],"Ovarian Cancer","Ovarian Carcinoma","Stage II Ovary Cancer","Stage II Ovarian Cancer","Stage III Ovary Cancer","Stage III Ovarian Cancer","Stage IV Ovary Cancer","Stage IV Ovarian Cancer","Epithelial Ovarian Cancer","Stage II Fallopian Tube Cancer","Stage III Fallopian Tube Cancer","Stage IV Fallopian Tube Cancer","Primary Peritoneal Carcinoma",[71,72,73,74,75,76,65,30,69],"ovarian cancer","propranolol","etodolac","MBRT","mind-body resilience training","music therapy","2026-06-30",{"date":79,"type":35},"2026-07-01",{"date":81,"type":35},"2022-06-17",{"date":83,"type":22},"2027-06-17",{"name":85,"class":42},"Memorial Sloan Kettering Cancer Center",7,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100634882","phase-3-a-study-comparing-bl-m07d1-with-physicians-choice-of-chemotherapy-in-patients-with-her2-expressing-platinum-resistant-recurrent-epithelial-ovarian-cancer-fallopian-tube-cancer-and-primary-peritoneal-cancer-100634882","NCT07545460","A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer","A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Be ≥18 years and ≤75 years old on the day of signing the informed consent form;\n3. Have an expected survival time of ≥3 months;\n4. Have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;\n5. Have previously received a platinum-based regimen and have been confirmed to have platinum-resistant recurrence;\n6. Have received a total of ≥1 and ≤3 prior lines of therapy;\n7. If previously confirmed to be folate receptor alpha (FRα)-positive, must have received treatment with mirvetuximab soravtansine;\n8. Agree to provide archived tumor tissue specimens (from primary or metastatic lesions) collected within 3 years, or fresh tissue samples;\n9. Have at least one measurable lesion as defined by RECIST v1.1;\n10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n11. Have recovered from toxicities of prior anti-tumor therapy to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n12. Have no severe cardiac dysfunction, with a left ventricular ejection fraction (LVEF) ≥50%;\n13. Meet the required organ function levels;\n14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, with a negative result, and must not be breastfeeding; all enrolled patients must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.\n\nExclusion Criteria:\n\n1. Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks before the first dose;\n2. Previously received ADC therapy with a topoisomerase I inhibitor as the payload, or HER2-ADC therapy;\n3. History of severe cardiovascular or cerebrovascular disease within six months before screening;\n4. Concurrent pulmonary disease resulting in severely impaired lung function;\n5. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n6. Diagnosed with active malignancy within 3 years before study randomization;\n7. Unstable thrombotic event requiring therapeutic intervention within 6 months before screening;\n8. Hypertension inadequately controlled by two antihypertensive medications;\n9. Patients with poorly controlled blood glucose levels;\n10. History of ILD treated with steroids, or current ILD, or Grade ≥2 radiation pneumonitis, etc.;\n11. Patients with active central nervous system (CNS) metastases;\n12. Patients with a history of allergy to recombinant humanized antibodies or to any excipient of BL-M07D1;\n13. Prior receipt of organ transplantation or allogeneic hematopoietic stem cell transplantation;\n14. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;\n15. Experienced severe infection within 4 weeks before the first dose of study drug;\n16. Presence of large serosal cavity effusions, or symptomatic serosal cavity effusions, etc.;\n17. Receiving long-term systemic corticosteroid therapy (e.g., \\>10 mg\u002Fday prednisone) prior to randomization;\n18. History of severe neurological or psychiatric disorders;\n19. Experienced serious non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;\n20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n21. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.;\n22. Received other unapproved clinical study drugs or treatments within 4 weeks before study randomization;\n23. Subjects who plan to receive or have received a live vaccine within 28 days before the first dose;\n24. Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for this study in the investigator's opinion.","ALL","75 Years",{"count":97,"type":22},404,[99],"PHASE3","This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.",[65,30,102],"Primary Peritoneal Cancer","NOT_YET_RECRUITING","2026-06-26",{"date":106,"type":35},"2026-06-29",{"date":108,"type":22},"2026-07",{"date":110,"type":22},"2028-12",{"name":112,"class":113},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",2,{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100579451","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-sacituzumab-tirumotecan-mk-2870-maintenance-treatment-versus-standard-of-care-in-participants-with-platinum-sensitive-recurrent-ovarian-cancer-mk-2870-022trofuse-022engot-ov84gog-3103-100579451","NCT06824467","A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022\u002FTroFuse-022\u002FENGOT-ov84\u002FGOG-3103)","A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022\u002FENGOT-ov84\u002FGOG-3103)","Inclusion Criteria:\n\n* Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies\n* Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)\n* Has platinum-sensitive epithelial OC\n* Has provided tissue of a tumor lesion that was not previously irradiated\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)\n* Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)\n\nExclusion Criteria:\n\n* Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma\n* Has platinum-resistant OC or platinum-refractory OC\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received more than 2 prior lines of systemic therapy for OC\n* Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)\n* Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids\n* Has an additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has an active infection requiring systemic therapy\n* Has active or ongoing stomatitis",{"count":123,"type":22},770,[99],"The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.",[57,30,102],{"date":106,"type":35},{"date":129,"type":35},"2025-04-09",{"date":131,"type":22},"2032-11-09",{"name":133,"class":113},"Merck Sharp & Dohme LLC",178,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100468301","phase-1-a-study-of-emiltatug-ledadotin-emi-le-in-participants-with-solid-tumors-100468301","NCT05377996","A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","A Phase 1\u002F2, First-in-human, Multicenter Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","Inclusion Criteria:\n\n* Recurrent or advanced solid tumor and has disease\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Participants in DES must have at least one measurable disease (target) lesion as defined by RECIST version 1.1.\n* Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1\n* Brain magnetic resonance imaging (MRI) during the Screening period unless obtained within 30 days prior to Screening (based on standard clinical care), if they meet either of the following criteria:\n\n  1. All participants with TNBC\n  2. Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.\n\nExclusion Criteria:\n\n* Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.\n* Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), whichever is less, or palliative radiation therapy to the chest within 3 months of starting study treatment or to other anatomic sites within 14 days of starting study treatment.\n* Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.\n* Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.\n* Prior B7-H4 targeted treatment.\n* History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.\n* Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could increase the risk of serious adverse events (SAEs) or interfere with per-protocol evaluations, in the judgment of either the Sponsor or the Investigator.\n* Clinically significant cardiovascular disease\n* Active keratitis (inflammation of the cornea of the eye)",{"count":143,"type":22},360,[145,25],"PHASE1","A Study of Emi-Le in Participants with Solid Tumors",[148,149,150,57,30,151,152],"Triple Negative Breast Cancer","Breast Cancer","Endometrial Cancer","Primary Peritoneal Cavity Cancer","Adenoid Cystic Carcinoma","2026-06-24",{"date":106,"type":35},{"date":156,"type":35},"2022-08-15",{"date":158,"type":22},"2027-12",{"name":160,"class":113},"Day One Biopharmaceuticals, Inc.",26,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100461346","risk-reducing-salpingectomy-with-delayed-oophorectomy-as-an-alternative-to-risk--reducing-salpingo-oophorectomy-in-high-risk-women-to-assess-the-safety-of-prevention---us-cohort-study-100461346","NCT05287451","Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and\u002For RAD51D gene germline mutation.\n2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2.\n\n   * The highest risk for cancer is mediated by the BRCA mutation. If a patient has multiple mutations, eligibility will be based on BRCA mutation.\n3. No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable.\n4. Presence of at least one fallopian tube.\n5. Participants may have a personal history of non-ovarian malignancy.\n6. Informed consent must be obtained and documented.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n1. Postmenopausal status (natural menopause or due to (cancer) treatment)\n\n   * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n   * A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation per the local standard of care can be considered.\n2. Wish for second stage RRO within two years after RRS (if clear at enrollment)\n3. Legally incapable\n4. Prior bilateral salpingectomy\n5. A personal history of ovarian, fallopian tube, or peritoneal cancer\n6. Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.",{"count":169,"type":22},100,[54],"This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence",[57,30],{"date":104,"type":35},{"date":175,"type":35},"2022-05-10",{"date":177,"type":22},"2026-12-26",{"name":179,"class":42},"M.D. Anderson Cancer Center",9,{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":21},"100576616","phase-2-investigation-of-ubamatamab-combination-therapy-in-adult-participants-with-platinum-resistant-ovarian-cancer-100576616","NCT06787612","Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer","Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer","Key Inclusion Criteria:\n\n1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)\n2. Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n4. Adequate organ and bone marrow function, as described in the protocol\n5. Platinum-Resistant Ovarian Cancer, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)\n2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)\n3. Another malignancy that is progressing or requires active treatment, as described in the protocol\n4. Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol\n5. Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency\n6. Moderate to large or ascites, as described in the protocol\n7. Bowel obstruction within last 3 months or current need for parenteral nutrition\n\nNOTE: Other protocol-defined inclusion\u002Fexclusion criteria apply",{"count":189,"type":22},220,[25],"This study is researching an experimental drug called ubamatamab, also referred to as \"study drug\". The study is focused on patients who have advanced ovarian cancer.\n\nThe aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \\[PLD\\]), referred to as \"combination drugs'.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug and its experimental combinations\n* How much study drug and fianlimab is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations",[57,30,102],[194],"Platinum Resistance","2026-06-22",{"date":197,"type":35},"2026-06-23",{"date":199,"type":35},"2025-05-28",{"date":201,"type":22},"2028-10-30",{"name":203,"class":113},"Regeneron Pharmaceuticals",{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":228},"100444784","phase-2-zen003694-combined-with-talazoparib-in-patients-with-recurrent-ovarian-cancer-100444784","NCT05071937","ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer","Phase ll Study of a BET Inhibitor, ZEN003694, Combined With a PARP Inhibitor, Talazoparib, in Patients With Recurrent Ovarian Cancer","Inclusion Criteria:\n\n1. Females age ≥ 18 years (at time of signing informed consent)\n2. ECOG status 0 or 1\n3. Pathologically documented ovarian, fallopian tube, or primary peritoneal carcinoma.\n4. Prior therapy with PARPi either as maintenance or therapeutic settings.\n5. All recurrent ovarian cancer both platinum sensitive and platinum resistant are allowed.\n6. Any prior number of cancer therapy regimens\n7. Measurable disease per RECIST 1.1\n8. Known BRCA1\u002F2 status\n9. Adequate laboratory parameters at Screening including:\n\n   1. Hemoglobin ≥ 9.0 gm\u002FdL without transfusions during the 4 weeks prior to Screening\n   2. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n   3. Platelet count ≥ 150,000\u002Fmm3\n   4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.0 x ULN or if liver function abnormalities due to liver metastases AST and ALT ≤ 5.0 x ULN\n   5. Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN for subjects with known Gilbert's syndrome)\n   6. Serum Creatinine ≤ 1.5 X ULN\n   7. Prothrombin time (PT), international normalized ratio (INR) and partial thromboplastin time (PTT) \\\u003C 1.5 x ULN\n10. Female subjects may be enrolled if they are not of childbearing potential, permanently sterile or who are post-menopausal, defined as no menses for at least 1 year without an alternative medical cause and FSH levels in the post-menopausal range. Female subjects of childbearing potential may be enrolled if they consistently and correctly use a highly effective form of contraception. Highly effective forms of contraception include: combined (estrogen and progestogen hormonal contraceptives (oral, intravaginal, transdermal) associated with inhibition of ovulation; progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence. Female subjects should not donate eggs from the time point of study drug administration until at least 7 months thereafter\n11. Females of childbearing potential must have a negative serum pregnancy test before the first dose of study drug and must agree to serum pregnancy tests during the study.\n12. Females may not be breast-feeding at the first dose of study drug, during study participation or through 7 months after the last dose of study drug.\n13. Ability to swallow capsules and comply with study procedures.\n14. Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures.\n15. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable with evidence of no disease progression for 6 months.\n\n    Exclusion Criteria:\n16. Current or anticipated use of medications known to be strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows. Strong inhibitors, inducers or substrates must be discontinued at least 7 days prior to the first administration of study drug.\n17. Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors.\n18. Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed\n19. Radiation to \\>25% of the bone marrow\n20. Treatment with a bone-targeted radionuclide within 6 weeks of first dose of study drug\n21. Prior chemotherapy or radiation within 3 weeks of study enrollment\n22. Have previously received an investigational BET inhibitor (including previous participation in studies with Zenith drug, ZEN003694)\n23. QTcF interval \\> 470 msec\n24. Insufficient recovery from prior treatment-related toxicities except for alopecia, fatigue and Grade 2 neuropathy\n25. Non-healing wound, ulcer or bone fracture (not including a pathological bone fracture caused by a pre-existing pathological bone lesion)\n26. Brain metastases not adequately treated and\u002For clinically stable (at the discretion of the Investigator) for at least 6 months prior to the start of study treatment.\n27. Patients with ovarian carcinosarcoma\n28. Known impaired cardiac function or clinically significant cardiac disease such as uncontrolled supraventricular arrhythmia, ventricular arrhythmia requiring therapy, or congestive heart failure (New York Heart Association functional class III or IV)\n29. Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug\n30. Known myelodysplastic syndrome\n31. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, or any other condition that could compromise safety or the patient's participation in the study\n32. Impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 or talazoparib\n33. Other known active cancer requiring therapy at time of study entry or that progressed or required treatment within 3 years prior to starting study drug (except for skin basal cell carcinoma or squamous cell carcinoma or in situ cervical cancer)\n34. History of infection with (screening tests not required): human immunodeficiency virus; hepatitis B virus with currently active disease defined as hepatitis B surface antigen (HBsAg) positivity; or hepatitis C virus unless previously treated and viral load is undetectable except following situations:\n\n    * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment are eligible for this trial.\n    * Patients with a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection are allowed to be included if: participant on a stable dose of antiviral therapy, HBV viral load below the limit of quantification. HCV viral load below the limit of quantification.\n35. Major surgery other than diagnostic surgery, dental surgery or stenting within 4 weeks prior to the first administration of study drug\n36. Concurrent participation in another clinical investigational treatment trial\n37. Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule",{"count":212,"type":22},33,[25],"This Phase 2, open label, study with safety lead in of oral talazoparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with recurrent ovarian, fallopian tube or primary peritoneal carcinoma.",[57,29,30],[217,218],"PARP enzyme","bromodomain and extra terminal domain (BET) proteins","2026-06-16",{"date":221,"type":35},"2026-06-18",{"date":223,"type":35},"2023-04-21",{"date":225,"type":22},"2034-12-31",{"name":227,"class":42},"Alexander B Olawaiye, MD",1,{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100584515","phase-2-a-study-to-assess-anti-tumor-activity-of-intravenously-iv-infused-carboplatin-with-mirvetuximab-soravtansine-in-participants-with-newly-diagnosed-folate-receptor-alpha-frexpressing-advanced-stage-serous-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100584515","NCT06890338","A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.","A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n* Be judged by the investigator and\u002For treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy.\n* Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer.\n* Participant meets the following disease criteria:\n\n  * Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and\n  * Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of \\>= 75% of viable tumor cells with moderate \\>= 2+ membrane staining by the Ventana Folate Receptor Alpha (VENTANA FOLR1) assay, FOLR1 Eligibility Testing - Ventana FOLR1 (FOLR1-2.1) RxDx - Commercial or Central, and\n  * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.\n\nExclusion Criteria:\n\n* Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade\u002Fborderline ovarian tumor.\n* Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.\n* Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin\n* Participants with the following ocular history and\u002For concurrent disorders:\n\n  * History of corneal transplantation;\n  * Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery;\n  * Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention;\n  * Active or chronic clinically significant (\\>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy);\n  * Active ocular conditions requiring ongoing treatment\u002Fmonitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema or an ocular condition with high risk of retinal detachment;\n  * Monocular vision with visual acuity in the worse eye, worse than 20\u002F200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye).\n* History of other malignancy within 3 years prior to signing study consent. -- Note: Participants with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.",{"count":237,"type":22},140,[25],"Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC).\n\nMirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States.\n\nParticipants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years .\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.",[65,30,102,241],"Neoadjuvant",[65,30,102,241,243,244,245,246,247,248,249],"Interval Debulking Surgery","Mirvetuximab Soravtansine","MIRV","IMGN853","ELAHERE(R)","Carboplatin","Bevacizumab","2026-06-15",{"date":219,"type":35},{"date":253,"type":35},"2025-11-21",{"date":255,"type":22},"2030-02",{"name":257,"class":113},"AbbVie",66,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":114},"100581914","phase-1-cirtuvivintolaparib-in-breast-cancer-susceptibility-genehomologous-recombination-deficiency-platinum-resistant-ovarian-cancer-100581914","NCT06856499","Cirtuvivint\u002FOlaparib in Breast Cancer Susceptibility Gene\u002FHomologous Recombination Deficiency Platinum Resistant Ovarian Cancer","Phase I Evaluation of Combination CLK\u002FDYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA\u002FHRD Platinum Resistant Ovarian Cancer","Inclusion Criteria:\n\n1. Provision to sign and date the consent form.\n2. Stated willingness to comply with all study procedures and be available for the duration of the study.\n3. Woman aged ≥18 years of age\n4. Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 1 or 2\n5. Patients must have a confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer\n6. Patients must have platinum-resistant disease defined as radiographic progression less than 6 months from last dose of most recent platinum therapy\n7. Patients must have measurable disease by defined RECIST 1.1 criteria\n8. Prior anticancer therapy:\n\n   * Patients must have received at least one prior platinum-based chemotherapy regimen\n   * Patients may not have received more than 3 prior lines of systemic therapy\n   * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy\n   * Maintenance therapy (eg, Bevacizumab, PARP inhibitors) will be considered part of preceding line of therapy (ie, not counted independently)\n   * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)\n   * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance\n   * Prior radiation is allowed and is not considered a line of treatment\n9. Patients must have had testing for BRCA mutation (tumor or germline) and tumor HRD testing, and have been positive for one and\u002For the other.\n10. Patients must have received a prior PARP inhibitor as either treatment or maintenance therapy\n11. Patients must have adequate hematologic, liver, and kidney function as defined as:\n\n    * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1500\u002FµL)\n    * Platelet count ≥ 100 x 109\u002FL (100,000 µL)\n    * Hemoglobin ≥ 10.0 g\u002FdL with no blood transfusion in the past 28 days\n    * Serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n    * Patients must have creatinine clearance estimated of ≥51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test\n    * Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN\n    * Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \\\u003C 3.0 x ULN)\n    * Serum albumin ≥ 2 g\u002FdL\n12. 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.\n13. Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible.\n\nExclusion Criteria:\n\n1. Patients with clear cell, mucinous, sarcomatous, low grade\u002Fborderline, germ cell, or sex-cord stromal type ovarian tumor\n2. Patients with platinum refractory disease as defined by those who have progressed during or within 4 weeks of receiving platinum-based therapy\n3. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment\n4. Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of myelodysplastic syndrome\u002Facute myeloid leukemia.\n5. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to:\n\n   * Uncontrolled major seizure disorder\n   * Unstable spinal cord compression\n   * Any psychiatric disorder that prohibits obtaining informed consent.\n   * Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of therapy\n6. Patients with clinically significant cardiac disease including, but not limited to, any of the following\n\n   * Myocardial infarction ≤ 6 months prior to first dose\n   * Uncontrolled ventricular arrhythmia, recent (within 3 months)\n   * Superior vena cava syndrome\n   * Unstable angina pectoris\n   * Uncontrolled congestive heart failure (New York Heart Association \\> class II)\n   * Uncontrolled ≥ Grade 3 hypertension (per CTCAE)\n   * Uncontrolled cardiac arrhythmias\n7. Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment\n8. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)\n9. Persistent toxicities (\\>\u002F= Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia or peripheral sensory neuropathy\n10. Patients with duodenal stent or other GI disorder\u002Fdefect that would interfere with absorption of oral medication\n\n    o Includes patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n11. Patients with known untreated or symptomatic central nervous system (CNS) metastases\n12. Prior known hypersensitivity reaction to study drugs and\u002For any of their excipients\n13. Minor or major surgical procedure within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n14. Inability to comply with study and follow-up procedures\n15. Patients deemed otherwise clinically unfit for clinical trial per investigators discretion.",{"count":267,"type":22},50,[145],"The purpose of this study is to learn about the safety and tolerability of Cirtuvivint in combination with Olaparib in platinum resistant ovarian cancer. The study also aims to determine the recommended dose of the combination therapy.\n\nIf a participant is a good fit for the study, and they enroll in the study, they will:\n\n* Visit the clinic often at the beginning of the study for physical exams, blood draws, vital signs, and other study and routine care procedures. After the first two months participants will visit the clinic every 28 days.\n* Take the study medications, Cirtuvivint and Olaparib. Participants will take Olaparib every day. Participants will either take Cirtuvivint 5 days per week or 2 days per week.",[271,102,30],"Endometrioid Ovarian Cancer","2026-06-02",{"date":274,"type":35},"2026-06-04",{"date":276,"type":35},"2025-12-08",{"date":278,"type":22},"2029-07",{"name":41,"class":42},{"id":281,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":26,"conditions":284,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":287,"leadSponsor":288,"locationsCount":289},"100507455",{"count":21,"type":22},[25],[28,29,30],{"date":274,"type":35},{"date":37,"type":35},{"date":39,"type":22},{"name":41,"class":42},5,{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":86},"100586411","phase-3-phase-3-trial-evaluating-the-safety--efficacy-of-imnn-001-administered-in-combination-w-standard-nact--adjuvant-chemotherapy-in-newly-diagnosed-patients-w-advanced-eoc-fallopian-tube-or-primary-peritoneal-cancer-100586411","NCT06915025","Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w\u002F Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w\u002F Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer","A Randomized Phase 3 Trial Evaluating the Safety & Efficacy of IP IMNN-001 Administered in Combination w\u002F Standard Neoadjuvant & Adjuvant Chemotherapy in Newly Diagnosed Patients w\u002F Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer","OVATION-3","Inclusion Criteria:\n\n1. Participants must be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent.\n2. Participants with a histologically confirmed diagnosis of high-grade non-mucinous epithelial ovarian (serous, endometrioid, carcinosarcoma, mixed epithelial pathologies), fallopian tube or peritoneal cancer that is Stage IIIB\u002FC or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria.\n3. Participants eligible to receive neoadjuvant chemotherapy.\n4. Participants will provide a tumor tissue sample at pre-screening or screening, via laparoscopy or image guided core biopsy for determination of confirmed biomarker tumor status (HRD vs. HRP). See biomarker status definitions in the section below.\n5. Participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin) within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, participants must discontinue breastfeeding prior to study entry.\n6. Participants must have adequate:\n\n   1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500\u002Fµl. Exceptions may be made in patients with benign ethnic neutropenia \\>800\u002Ful with approval of a medical monitor. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000\u002Fµl.\n   2. Renal function: eGFR \\> 60 ml\u002Fmin\u002F1.73m2\n   3. Hepatic function: Bilirubin ≤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN. Exceptions due to hepatic metastases can be considered in consultation with medical monitor.\n   4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1 as defined by CTCAE version 5.0.\n7. Participants must have an ECOG score of 0, 1 or 2.\n8. Participants should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within 4 weeks of study entry.\n9. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n\nExclusion Criteria:\n\n1. Participant who has received prior treatment with IMNN-001.\n2. Participant who has received oral or parenteral corticosteroids (\\>10 mg prednisone) within 2 weeks of first dose of IMNN-001 (if applicable) or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n3. Participant has mucinous, germ cell, transitional cell, clear cell, undifferentiated, or non-epithelial ovarian cancer.\n4. Participant has low-grade or Grade 1 epithelial ovarian cancer.\n5. Participant of childbearing potential, not practicing adequate contraception, participant who is pregnant, or participant who is breastfeeding are not eligible for this trial.\n6. Participant has a bowel obstruction by clinical symptoms or computed tomography (CT) scan, sub-occlusive mesenteric disease, abdominal or gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess.\n7. Participant has been diagnosed and\u002For treated with any therapy for invasive cancer \\\u003C3 years from study enrollment, completed adjuvant chemotherapy and\u002For targeted therapy at least 3 years from enrollment, or completed adjuvant hormonal therapy less than 4 weeks from enrollment.\n8. Participant with definitively treated non-invasive malignancies such as cervical carcinoma in situ, ductal carcinoma in situ, grade 1 or 2 Stage IA endometrioid endometrial cancer, or non-melanomatous skin cancer are allowed.\n9. Participant with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the participant to extreme risk or decreased life expectancy.\n10. Participant has known active hepatitis or HIV with detectable viral load.\n11. Participant has a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, IMNN-001, or their excipients.\n12. Prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., immunotherapy, anticancer therapy, surgery, radiation therapy).\n13. Participant is receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n14. Participant who has received prior radiotherapy to any portion of the abdominal cavity or pelvis is excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed at least 3 years prior to registration, and the participant remains free of recurrent or metastatic disease.\n15. Participant who has received prior chemotherapy for any abdominal or pelvic tumor is excluded. Participant may have received prior adjuvant chemotherapy for localized breast cancer, if it was completed at least three years prior to registration, and that the participant remains free of recurrent or metastatic disease.\n16. Participant with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n17. Participant who will receive bevacizumab with the neoadjuvant or adjuvant treatment, or as maintenance will be excluded.\n18. Participant with any condition\u002Fanomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including abdominal surgery within 4 weeks of study entry (for reason other than IP port placement or laparoscopic diagnosis of epithelial ovarian cancer), intestinal dysfunction as defined in #6 above.",{"count":299,"type":22},500,[99],"This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.",[65,57,30,69],[304,305,296],"IMNN-001","GEN-1","2026-06-01",{"date":272,"type":35},{"date":309,"type":35},"2025-07-09",{"date":311,"type":22},"2032-10-31",{"name":313,"class":113},"Imunon",{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":324,"phases":4,"briefSummary":325,"conditions":326,"keywords":332,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":114},"100517943","performance-of-symmcora-vs-v-loc-suture-material-in-patients-undergoing-laparoscopic-total-hysterectomy-100517943","NCT06024109","Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy","Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA® Mid-term Unidirectional Barbed Suture Versus V-loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy","BARHYSTER","Inclusion Criteria:\n\n* Females undergoing an elective, laparoscopic total hysterectomy\n* Age ≥ 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Open surgery\n* Patients undergone immunosuppressive drug treatment within the prior 6 months\n* Patients with hypersensitivity or allergy to the suture material.\n* Participation in another clinical study\n* Non-compliance of patient",{"count":323,"type":22},132,"OBSERVATIONAL","The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate.\n\nSecondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.",[327,328,329,330,57,30,331,150],"Abnormal Uterine Bleeding","Endometriosis","Uterine Prolapse","Uterine Cancer","Cervical Cancer",[333,334,335,336],"Barbed Suture","Hysterectomy","Laparoscopy","Minimal Invasive",{"date":272,"type":35},{"date":339,"type":35},"2024-03-19",{"date":341,"type":22},"2027-08",{"name":343,"class":113},"Aesculap AG",{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":355,"conditions":356,"keywords":357,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":364},"100496112","phase-1-phase-ii-imnn-001-also-known-as-gen-1-on-sll-with-bev-and-nact-newly-diagnosed-advanced-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100496112","NCT05739981","Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer","Phase II Study Evaluating the Effect of IMNN-001 on Second Look Laparoscopy (SLL) in Combination With Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Newly Diagnosed With Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer","MRD","Inclusion Criteria:\n\n1. Subjects with ovarian, fallopian tube, or primary peritoneal carcinoma with high grade serous adenocarcinoma histology are eligible. Poorly differentiated carcinomas consistent with high grade serous histology are eligible. Pathologic diagnosis may be via frozen section or permanent pathology from diagnostic laparoscopy during the screening phase or via pre-enrollment core biopsy (but not cytology).\n2. Subjects must have an International Federation of Gynecology and Obstetrics (FIGO) stage of III or IV who based on standard of care clinical considerations have been recommended to undergo neoadjuvant therapy per standard clinical determination by their oncology provider.\n3. Subjects must have adequate: bone marrow function, renal function, hepatic function, and neurologic function.\n4. Subjects should be free of active infection requiring isolation, parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry. Subjects with diagnosis of COVID-19 infection must be 14 days after positive test or onset of symptoms.\n5. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n6. Subjects must have a performance status score of 0-1 by Eastern Cooperative Group (ECOG) criteria.\n7. Subjects of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and agree to practice an effective form of contraception. If applicable, subjects must discontinue breastfeeding prior to study entry.\n8. Subjects must have signed an IRB-approved informed consent.\n9. Subjects must be at least 18 years old.\n\nExclusion Criteria:\n\n1. Subjects who have received prior treatment with IMNN-001.\n2. Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMNN-001 or other drugs used in this study.\n3. Subjects who have received oral or parenteral corticosteroids within 2 weeks of first dose of IMNN-001 (if applicable) or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid (prednisone equivalent of \\> 10 mg\u002Fday) use not related to chemotherapy administration. Steroid prophylaxis for IV contrast allergy is allowed.\n4. Subjects with autoimmune disease requiring immunosuppressive therapy within the last 2 years. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n5. Subjects with known human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV) infections are excluded.\n6. Subjects with other invasive malignancies are excluded if there is any evidence of the invasive malignancy being present within the last three years. Subjects are also excluded if their previous cancer treatment contraindicates this protocol therapy. Subjects with non-invasive malignancies such as non-melanoma skin cancer, melanoma in-situ, etc. are eligible.\n7. Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed more than three years prior to registration, and the subject remains free of recurrent or metastatic disease.\n8. Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Subjects may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the subject remains free of recurrent or metastatic disease.\n9. Subjects with known active hepatitis.\n10. Subjects with nephrotic syndrome (proteinuria Grade 2 or greater).\n11. Subjects with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the subject to extreme risk or decreased life expectancy.\n12. Subjects with clinically significant cardiovascular disease.\n13. Subjects of childbearing potential, not practicing adequate contraception, subjects who are pregnant, or subjects who are breastfeeding are not eligible for this trial.\n14. Subjects with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n15. Subjects with a history of diverticulitis within the past 6 months. Diverticulosis is not exclusionary.\n16. Subjects having hemoptysis within the last month.\n17. Subjects with any condition\u002Fanomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, fistulas, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"count":353,"type":22},30,[145,25],"This is a 1:1 randomized, open label, multi-center phase I\u002FII trial to evaluate the safety, dosing, efficacy, and biological activity of adding IMNN-001 to chemotherapy + BEV compared to chemotherapy + BEV alone.",[57,30,102],[304,305],{"date":272,"type":35},{"date":360,"type":35},"2023-02-10",{"date":362,"type":22},"2028-08-30",{"name":313,"class":113},4,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":388,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":258},"100483771","phase-1-rinatabart-sesutecan-rina-s-pro1184-gen1184-for-advanced-solid-tumors-gct1184-01-pro1184-001-100483771","NCT05579366","Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01\u002F PRO1184-001)","Phase 1\u002F2 Study of Rina-S in Patients With Locally Advanced and\u002For Metastatic Solid Tumors","RAINFOL-01","Inclusion Criteria:\n\nPart A and B:\n\n* Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).\n* Previously received therapies known to confer clinical benefit.\n* Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.\n\nPart C, E, and H:\n\nParticipants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.\n\n* High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)\n* Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.\n* Participants must have platinum-resistant ovarian cancer.\n* Participants must have received prior bevacizumab or approved biosimilar.\n* Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration \\[FDA\\]-approved test in a Clinical Laboratory Improvement Amendments \\[CLIA\\]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.\n* Measurable disease per the RECIST v1.1 at baseline.\n\nPart D:\n\nCohort D1:\n\n* Participants must have platinum-sensitive ovarian cancer.\n* Participants must have received 1 to 3 prior lines of therapy.\n\nCohort D2:\n\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.\n* Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.\n\n  * Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (\\>183 days) or more from the last dose of platinum-based therapy.\n\nCohort D3:\n\n• Endometrial cancer (any subtype excluding sarcoma).\n\nCohort D4:\n\n• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).\n\nPart F and G:\n\n* Participants must have histologically or cytologically confirmed EC.\n* Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.\n* Participants must have received 1 to 3 prior lines of therapy, and must have progressed radiographically on or after their most recent line of therapy:\n* Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-\\[L\\])1 inhibitor.\n* Participants who progress \\>12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.\n* Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart I:\n\n* Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low grade\u002Fborderline ovarian tumors).\n* Participants must have platinum sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart J:\n\n* Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart K:\n\n* Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nExclusion Criteria:\n\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids within the past 2 years, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.\n\nNote: Other protocol-defined inclusion\u002Fexclusion may apply.",{"count":374,"type":22},884,[145,25],"This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.\n\nParticipants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).",[378,379,69,30,150,380,381,382,383,148,384,385,386,387,330],"High Grade Epithelial Ovarian Cancer","High Grade Serous Ovarian Cancer","Non-small Cell Lung Cancer","Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)","Mesothelioma","Breast Adenocarcinoma","Hormone Receptor-positive\u002FHer2 Negative Breast Cancer","Platinum-resistant Ovarian Cancer (PROC)","Platinum Sensitive Ovarian Cancer (PSOC)","Primary Refractory Ovarian Cancer",[389,390,391,392,71,393,394,395,396,397,398,399,400,401,402,403],"antibody-drug conjugate","folate receptor alpha","folate receptor","solid tumor","primary peritoneal carcinoma","fallopian tube cancer","endometrial cancer","non-small cell lung cancer","mesothelioma","breast cancer","triple negative breast cancer","hormone receptor-positive (HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer","topoisomerase I inhibitor","PROC","epidermal growth factor receptor (EGFR)-mutated NSCLC",{"date":405,"type":35},"2026-06-03",{"date":407,"type":35},"2022-12-07",{"date":409,"type":22},"2027-10",{"name":411,"class":113},"Genmab",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":427,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":438},"100594848","phase-2-a-study-to-assess-change-in-disease-activity-and-adverse-events-in-adult-participants-with-gynecologic-cancers-receiving-intravenous-infusion-of-imgn151-as-monotherapy-or-in-combination-with-other-therapies-100594848","NCT07024784","A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies","A Phase 1b Dose Escalation and Expansion Study of IMGN151 as Monotherapy and in Combination With Other Anti-Cancer Therapies in Subjects With Gynecologic Cancers","Inclusion Criteria:\n\n* ECOG performance status of 0 or 1\n* Participants (except for platinum-sensitive ovarian, fallopian tube, and primary peritoneal cancer (PSOC) participants without disease progression after platinum combination standard of care therapy in Arms B and D) will have ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiographically measured by the investigator).\n* Participants will have high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC).\n* Participant has completed prior therapy within the specified times below:\n\n  * Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of IMGN151.\n  * Focal radiation completed ≥ 2 weeks prior to the first dose of study treatment.\n\nExclusion Criteria:\n\n* Participants with ovarian cancer with histologies including: endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, as well a low-grade or borderline ovarian tumor.\n* History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study treatment.\n* Prior treatment with FRα-targeting therapy.\n* Prior wide-field radiotherapy affecting more than 20% of the bone marrow.",{"count":420,"type":22},377,[25],"Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety and tolerability of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies in adult participants with gynecologic cancers.\n\nIMGN151 is an investigational drug being developed for the treatment of gynecologic cancers. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Around 377 participants with gynecologic cancers will be enrolled in the study at approximately 50 sites worldwide.\n\nParticipants will receive intravenous infusions of IMGN151 as monotherapy or in combination with anti-cancer therapies according to their assigned study arm. In Arm A, participants will receive IMGN151 in combination with carboplatin on Day 1 of each cycle. In Arm B, participants will receive IMGN151 in combination with olaparib, twice a day (BID) on Day 1 of each cycle. In Arm C, participants will receive IMGN151 in combination with bevacizumab on Day 1 of each cycle. In Arm D, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. In Arm E, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. In Arm F, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. The total study duration will be approximately 3 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.",[424,425,30,426],"Gynecologic Cancers","Platinum-Sensitive Ovarian Cancer","Primary Peritoneal Cancer (PSOC)",[424,425,428,30,426,429,430],"Platinum-Resistant Ovarian Cancer","Cancer","IMGN151","2026-05-29",{"date":272,"type":35},{"date":434,"type":35},"2025-07-30",{"date":436,"type":22},"2028-02",{"name":257,"class":113},16,{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":23,"phases":448,"briefSummary":449,"conditions":450,"keywords":452,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":180},"100623921","phase-1-drug-drug-interaction-study-with-azd5335-and-itraconazole-in-participants-with-ovarian-primary-peritoneal-or-fallopian-tube-cancer-100623921","NCT07402915","Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","An Open-label, Fixed Sequence Phase I Study to Evaluate the Effect of Itraconazole (a Strong CYP3A Inhibitor) on the Pharmacokinetics of AZ14170132, the TOP1 Inhibitor Payload of the Antibody Drug Conjugate AZD5335, in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","Inclusion Criteria:\n\n* Participants with Platinum-resistant, relapsed, high- grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer and: (a) have received at least 1 prior line of platinum-containing chemotherapy and have progressed on or within 6 months after the date of the last dose of platinum; (b) must have received prior bevacizumab and\u002For Poly (ADP-ribose) polymerase (PARP) inhibitors according to local guidelines, unless ineligible.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nExclusion Criteria:\n\n* Spinal cord compression or a history of leptomeningeal carcinomatosis.\n* Unresolved toxicities of Grade ≥ 2 (National Cancer Institute-Common Terminology Criteria for Adverse Events v5.0) from prior therapy.\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Uncontrolled intercurrent illness within 12 months prior to screening.\n* Any other contraindication for receiving itraconazole according to the prescribing information and the Investigator.",{"count":447,"type":22},24,[145],"The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.",[30,57,451],"Primary Peritoneal",[453,454],"CYP3A inhibitor","TOP1 inhibitor payload","2026-05-19",{"date":457,"type":35},"2026-05-20",{"date":459,"type":35},"2026-01-26",{"date":461,"type":22},"2027-10-15",{"name":463,"class":113},"AstraZeneca",{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":23,"phases":473,"briefSummary":474,"conditions":475,"keywords":480,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":114},"100416360","phase-1-microdevice-in-ovarian-fallopian-tube-and-peritoneal-cancer-100416360","NCT04701645","Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer","Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Ovarian, Fallopian Tube, and Peritoneal Cancer","Inclusion Criteria:\n\n* Participants must have suspected or confirmed clinically advanced stage (III-IV, defined as disease outside of the pelvis) ovarian, fallopian tube, or peritoneal cancer. If a patient has suspected ovarian cancer but final histologic analysis does not show evidence of ovarian cancer, the patient will be removed from the study and replaced.\n* Participants must meet one of the following clinical categories:\n\n  * Cohort 1: Patients with a new or suspected diagnosis of ovarian cancer who are deemed surgical candidates for primary cytoreductive surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.\n  * Cohort 2: Patients with newly diagnosed ovarian cancers who are being considered for either primary surgery or neoadjuvant chemotherapy by their surgical gynecologic oncologist, and who require a laparoscopic procedure to determine their candidacy for surgery.\n  * Cohort 3: Patients with recurrent ovarian cancer who are candidates for secondary cytoreduction, e.g. to confirm diagnosis of recurrent ovarian cancer and\u002For remove oligometastatic lesions.\n  * Cohort 4: Patients with newly diagnosed ovarian cancers who have undergone neoadjuvant chemotherapy and are deemed surgical candidates for interval debulking surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.\n* Participants must be 18 years of age or older.\n* Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures by their treating gynecologic oncologist and medical oncologist.\n* Participants will undergo laboratory testing within 14 days\\* prior to the microdevice placement.\n\n  * Patients must have absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelets ≥ 75,000\u002FmcL\n  * PT (INR) \\\u003C 1.5\n  * PTT \\\u003C 1.5x control\n  * Women of childbearing potential must have negative pregnancy test (urine or serum) \\*\\*Cohort 4 patients should undergo laboratory testing within 7 days prior to the microdevice placement\n* Participants must be evaluated by a surgical gynecologic oncologist who will determine the clinically appropriate treatment strategy (primary surgery or neoadjuvant chemotherapy) based on clinical history and extent of disease. The patient's surgical and\u002For medical gynecologic oncologist must also confirm the patient's medical fitness to undergo an additional biopsy procedure and the indicated surgical procedure. The patient must have a plan to undergo surgery for clinical purposes.\n* The following criteria must be met:\n\n  * Participants must have undergone an abdominal\u002Fpelvic CT scan that both assesses the extent of disease and identifies an area of tumor amenable to safe microdevice placement. CT scans with both oral and IV contrast media are preferred but not required.\n\nCT scans performed at outside institutions are acceptable providing that the images are considered adequate to assess the stage of the disease and to assess the safety and feasibility of the placement of the microdevices and their retrieval during standard-of care surgery. CT scan must be completed within 4 weeks prior to the microdevice placement.\n\n* Patient has sufficient volume of disease as measured by CT scan to allow implantation of the microdevice.\n* Patient has sufficient volume of disease that removal of the lesion where the microdevice is placed will not potentially affect adequate tissue for diagnosis.\n* A lesion can be selected where the microdevice is to be implanted that is\n\n  * Amenable to percutaneous placement\n  * Amenable to removal at the time of surgery or laparoscopy. If patient is undergoing laparoscopy, the lesion must be able to be removed using a laparoscopic approach in a manner that would not significantly alter the procedure or affect patient safety, per opinion of the surgical oncologist.\n\n    * Patients must have the ability to understand and the willingness to sign a written informed consent document.\n    * Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit the safety of a biopsy and\u002For surgery.\n* Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the microdevice placement and the potential risk to the pregnancy of the biopsy\u002Fdevice placement in an abdominal lesion.\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures.\n* Significant risk factors (including, but not limited to, high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines. (Patients taking low-dose aspirin only do not need to be excluded.)",{"count":472,"type":22},20,[145],"This pilot study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.\n\nThe name of the study intervention involved in this study is:\n\n-implantable microdevice",[57,30,29,476,477,478,479],"Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Fallopian Tube Cancer Stage IV","Fallopian Tube Cancer Stage III",[57,30,29,481,476,477,478,479],"Implantable Microdevice","2026-05-14",{"date":484,"type":35},"2026-05-18",{"date":486,"type":35},"2022-11-01",{"date":488,"type":22},"2027-06-30",{"name":490,"class":42},"Brigham and Women's Hospital",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":501,"conditions":502,"keywords":507,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":228},"100638121","phase-2-romiplostim-n01-plus-atra-for-persistent-isolated-chemotherapy-induced-thrombocytopenia-after-complete-remission-of-gynecologic-breast-or-lung-solid-tumors-100638121","NCT07586826","Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors","A Prospective, Randomized, Open-Label, Controlled Study of Romiplostim N01 Combined With All-Trans Retinoic Acid Versus Romiplostim N01 Alone for Persistent Isolated Chemotherapy-Induced Thrombocytopenia in Patients With Complete Remission of Gynecologic, Breast, or Lung Solid Tumors","N01-A-PICIT-GT","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Prior diagnosis of a selected gynecologic, breast, or lung solid tumor, including but not limited to non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer. Other eligible tumor types may include endometrial cancer, cervical cancer, fallopian tube cancer, primary peritoneal cancer, and other lung cancers, if clinically appropriate and if all other eligibility criteria are met.\n3. Complete remission of the underlying tumor after chemotherapy or antitumor treatment, with tumor-related treatment discontinued for at least 12 weeks before enrollment, no evidence of recurrence or progression by specialist assessment, and no current need for additional tumor-directed therapy.\n4. Persistent isolated chemotherapy-induced thrombocytopenia, defined as platelet count \\\u003C30 x 10\\^9\u002FL on two peripheral blood tests at least 7 days apart; or platelet count slightly higher than 30 x 10\\^9\u002FL with dependence on platelet transfusion to maintain a safe platelet level.\n5. Thrombocytopenia has persisted since the last chemotherapy treatment without a clear trend of spontaneous recovery.\n6. Red blood cell count and neutrophil count are generally preserved, without clinically significant anemia or neutropenia.\n7. Bone marrow assessment performed within 1 year after tumor diagnosis and chemotherapy shows no tumor cell infiltration; megakaryocyte count is normal or increased, with or without maturation impairment.\n8. No hepatosplenomegaly, portal hypertension, or other evidence suggesting abnormal platelet redistribution as the main cause of thrombocytopenia.\n9. Prior treatment with at least one thrombopoietin receptor agonist or recombinant human thrombopoietin for PICIT without response, defined as failure of platelet count to rise to a safe level or to at least 2 times baseline after at least 2 weeks of standard-dose treatment.\n10. No prior use of Romiplostim N01.\n11. Other platelet-raising medications have been discontinued before enrollment. No washout period is required for prior thrombopoietin receptor agonists; other investigational drugs or off-label treatments must be discontinued for at least 1 month before enrollment.\n12. Ability to understand and sign the informed consent form and willingness to comply with study visits and procedures.\n13. Participants of reproductive potential must agree to use effective contraception during study treatment. Female participants of childbearing potential must have a negative pregnancy test before enrollment.\n\nExclusion Criteria:\n\n1. Other hematologic diseases that may affect hematopoiesis or cause thrombocytopenia, including but not limited to aplastic anemia, myelodysplastic syndrome, leukemia or other hematologic malignancies, or a clear history of primary immune thrombocytopenia.\n2. Active recurrence or progression of the underlying tumor, or evidence of bone marrow metastasis or tumor cell infiltration on bone marrow examination.\n3. Uncontrolled chronic viral infection, including hepatitis B, hepatitis C, or HIV infection, or active severe infection at screening or within 4 weeks before screening.\n4. Severe cardiac, hepatic, renal, or other organ dysfunction, or any serious organic disease that would make the participant unable to tolerate study treatment.\n5. Pregnancy or breastfeeding.\n6. Known severe hypersensitivity to Romiplostim, Romiplostim N01, ATRA, or any component of the study drugs.\n7. Prior Romiplostim treatment associated with severe adverse reactions or lack of efficacy.\n8. Poor compliance, inability to complete treatment or follow-up, psychiatric or psychological condition that prevents understanding of the study procedures, or any other condition that, in the investigator's judgment, may increase study risk or interfere with interpretation of study results.",{"count":189,"type":22},[25],"This is a prospective, randomized, open-label, active-controlled study to evaluate the efficacy and safety of Romiplostim N01 plus all-trans retinoic acid (ATRA) compared with Romiplostim N01 alone in adults with persistent isolated chemotherapy-induced thrombocytopenia (PICIT) after complete remission of selected gynecologic, breast, or lung solid tumors, including but not limited to non-small cell lung cancer (NSCLC), ovarian cancer, and breast cancer.\n\nEligible participants will be randomized in a 1:1 ratio to receive Romiplostim N01 plus oral ATRA or Romiplostim N01 alone for 12 weeks, with follow-up through Week 24. The primary outcome is the overall platelet response rate at Week 12, defined as platelet count \\>50 x 10\\^9\u002FL in at least 2 of the last 3 scheduled platelet assessments up to Week 12. Secondary outcomes include sustained response during Weeks 13 to 24, complete and partial response rates, duration of response, time to response, platelet count changes, platelet transfusion requirements, bleeding events, and safety.",[503,504,424,57,149,505,506,331,30,102],"Persistent Isolated Chemotherapy-Induced Thrombocytopenia","Chemotherapy-Induced Thrombocytopenia","Lung Cancer","Non-Small Cell Lung Cancer",[508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523,524,525,526,527,102,30],"PICIT","Persistent isolated chemotherapy-induced thrombocytopenia","CIT","Chemotherapy-induced thrombocytopenia","Romiplostim N01","ATRA","All-trans retinoic acid","Tretinoin","Thrombopoietin receptor agonist","Gynecologic cancer","Ovarian cancer","Breast cancer","Lung cancer","NSCLC","Non-small cell lung cancer","Endometrial cancer","Cervical cancer","Complete remission","Platelet response","Thrombocytopenia","2026-05-08",{"date":482,"type":35},{"date":531,"type":35},"2025-12-22",{"date":533,"type":22},"2027-12-31",{"name":535,"class":42},"Peking University People's Hospital",{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":23,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":228},"100592497","phase-3-a-study-comparing-bl-b01d1-with-the-investigators-choice-of-chemotherapy-in-patients-with-platinum-resistant-recurrent-epithelial-ovarian-cancerpanku-gyn01-100592497","NCT06994195","A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)","A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Age: ≥18 years old;\n3. Expected survival time ≥3 months;\n4. Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;\n5. Previously treated with a platinum-based regimen and confirmed to have platinum-resistant recurrence;\n6. Previously received 1-3 lines of systemic anti-tumor therapy, with radiographic evidence of disease progression during or after the last line of treatment or intolerance to the current treatment prior to randomization;\n7. For subjects with documented folate receptor-alpha (FRα) positivity, progression must have occurred after treatment with mirvetuximab soravtansine;\n8. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 3 years;\n9. Must have at least one measurable lesion as defined by RECIST v1.1;\n10. ECOG performance status score of 0 or 1;\n11. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n12. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n13. Organ function levels must meet the requirements;\n14. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n15. For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients should use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, targeted therapy, biologic therapy, etc., within 4 weeks or 5 half-lives prior to study randomization and palliative radiotherapy, etc., within 2 weeks;\n2. Patients with locally advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer who are eligible for radical locoregional therapy;\n3. Front line received ADCs targeting topoisomerase I inhibitors or EGFR and\u002For HER3;\n4. History of severe heart disease and cerebrovascular disease;\n5. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;\n6. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;\n7. Diagnosed with active malignancy within 3 years before randomization;\n8. Hypertension poorly controlled by two antihypertensive drugs;\n9. Patients with poor glycemic control;\n10. Patients with grade ≥1 radiation pneumonitis according to the RTOG\u002FEORTC definition; Previous history of ILD;\n11. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;\n12. Patients with active central nervous system metastases;\n13. Severe infection occurred within 4 weeks before randomization in study 13; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;\n14. Patients with massive or symptomatic effusions or poorly controlled effusions;\n15. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;\n16. Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent;\n17. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;\n18. Patients with inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;\n19. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;\n20. Had a history of autologous or allogeneic stem cell transplantation;\n21. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;\n22. A history of severe neurological or psychiatric illness;\n23. Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;\n24. Subjects who were scheduled to be vaccinated or received live vaccine within 28 days before study randomization;\n25. Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.",{"count":544,"type":22},384,[99],"This trial is a registered, phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian cancer.",[65,30,102],"2026-04-15",{"date":550,"type":35},"2026-04-20",{"date":552,"type":35},"2025-08-04",{"date":158,"type":22},{"name":112,"class":113},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":568,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":596},"100585743","phase-2-relacorilant-in-combination-with-different-treatment-regimens-in-patients-with-gynecological-cancers-100585743","NCT06906341","Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers","An Open-label, Global, Multi-Arm Study to Evaluate the Efficacy and Safety of Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (BELLA)","Inclusion Criteria:\n\nArms A and B\n\n* Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma\n* Arm A Only: Platinum-resistant disease\n* Arm B Only: Platinum-sensitive disease who had progression while receiving treatment with a poly(ADP-ribose) polymerase (PARP) inhibitor\n* Life expectancy of ≥3 months\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Able to swallow and retain oral medication\n* 1 to 3 lines of prior systemic anticancer therapy\n* Adequate organ function\n* Negative pregnancy test for patients of childbearing potential\n\nArm C\n\n* Stage III or IV, recurrent, or metastatic endometrial cancer\n* Life expectancy of ≥3 months\n* ECOG performance status of 0 or 1\n* Able to swallow and retain oral medication\n* Prior treatment with a platinum agent and an approved anti-Programmed Cell Death Ligand 1 (PD\\[L\\]1) antibody\n* 1 to 2 lines of prior systemic anticancer therapy for endometrial cancer\n* Must consent to provide an available formalin-fixed paraffin-embedded (FFPE) tumor tissue block or recently cut sections\n* Adequate organ function\n* Negative pregnancy test for patients of childbearing potential\n\nExclusion Criteria:\n\nArm A and B\n\n* Arm A Only: Has progressed while receiving weekly paclitaxel or nab-paclitaxel\n* Prior enrollment in a clinical trial of relacorilant\n* Prior anticancer therapy related toxicities not resolved to grade ≤1\n* Any surgery within 4 weeks prior to enrollment\n* Wide-field radiation to more than 25% of marrow-bearing areas\n* Medical conditions requiring chronic or frequent treatment with corticosteroids\n* Concurrent treatment with mifepristone or other glucocorticoid receptor modulators\n* Peripheral neuropathy from any cause \\>Grade 1\n* Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic\n* Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation\n* Bowel obstruction ≤12 weeks prior to study entry\n* Ascites or pleural effusions requiring therapeutic paracentesis\n* Untreated or symptomatic central nervous system metastases\n* History of other malignancy within 3 years prior to enrollment\n* Has received a live vaccine within 30 days prior to the study start date\n\nArm C\n\n* Has progressed while receiving weekly paclitaxel or nab-paclitaxel\n* Prior enrollment in a clinical trial of relacorilant\n* Prior anticancer therapy related toxicities not resolved to grade ≤1\n* Any surgery within 4 weeks prior to enrollment\n* Wide-field radiation to more than 25% of marrow-bearing areas\n* Medical conditions requiring chronic or frequent treatment with corticosteroids\n* Concurrent treatment with mifepristone or other glucocorticoid receptor modulators\n* Peripheral neuropathy from any cause \\>Grade 1\n* Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation\n* Bowel obstruction ≤12 weeks prior to study entry\n* Ascites or pleural effusions requiring therapeutic paracentesis\n* History of other malignancy within 3 years prior to enrollment\n* Has received a live vaccine within 30 days prior to the study start date\n* Patients with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.",{"count":563,"type":22},270,[25],"This is a Phase 2, open-label, global, multi-arm study to evaluate efficacy and safety of relacorilant in combination with other treatments in patients with gynecological cancers.",[57,30,567,150],"Peritoneal Neoplasms",[569,570,571,572,573,574,575,567,576,577,578,579,580,581,582,583,584,249,585,586],"Genital Neoplasms, Female","Neoplasms by Site","Fallopian Tube Diseases","Ovarian Diseases","Neoplasms","Fallopian Tube Neoplasms","Ovarian Neoplasms","Paclitaxel","Albumin-Bound Paclitaxel","Ovarian","Peritoneal or Advanced Fallopian Tube Cancer","High Grade","Platinum Resistant","Relacorilant","Bella","Nab-paclitaxel","Endometrial Neoplasm","Endometrial","2026-04-09",{"date":589,"type":35},"2026-04-14",{"date":591,"type":35},"2025-04-11",{"date":593,"type":22},"2026-12",{"name":595,"class":113},"Corcept Therapeutics",49,{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":603,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":607,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":447},"100402145","phase-1-a-study-of-azenosertib-zn-c3-in-patients-with-ovarian-cancer-100402145","NCT04516447","A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer","A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer","MUIR","INCLUSION CRITERIA:\n\nFor Part 1:\n\n* Histologically or cytologically confirmed FIGO Stage III\u002FIV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.\n* Subjects must have received 1 or 2 prior therapeutic regimens\u002Flines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin.\n* The disease must be platinum resistant (ie, the PFI must have been \\\u003C 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed.\n\nFor Part 2 Dose Escalation:\n\nPrior therapy:\n\n• Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy\n\nResponse to prior platinum therapy:\n\n1. In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.\n2. In the 2L setting:\n\n   1. Progressive Disease \\>183 days after receiving the last dose of platinum chemotherapy in the 1L setting,\n   2. Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy.\n\n      * Adequate hematologic, and organ function\n\nFor Part 2 Dose Expansion:\n\n* Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease\n* Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply\n\nEXCLUSION CRITERIA:\n\n* Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.\n* Subjects with carcinosarcomas (even if there is a serous component)\n* A serious illness or medical condition(s)\n* Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.\n\nAdditional protocol-defined exclusion criteria may apply",{"count":606,"type":22},172,[145],"This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.",[610,65,30,29],"Solid Tumor",[610],"2026-04-01",{"date":614,"type":35},"2026-04-07",{"date":616,"type":35},"2020-10-26",{"date":618,"type":22},"2028-06-30",{"name":620,"class":113},"K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc",{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":23,"phases":630,"briefSummary":631,"conditions":632,"keywords":637,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":86},"100538389","phase-2-study-of-acute-normovolemic-hemodilution-anh-in-people-with-ovarian-cancer-who-are-having-cytoreductive-surgery-100538389","NCT06290193","Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery","A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer","Inclusion Criteria:\n\n* Adults (≥18 years)\n* BLOODS score ≥2 as calculated by surgeon\n* High preoperative suspicion (or diagnosis) of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (stage IIIC or IV), as determined by CT or MRI of the abdomen\u002Fpelvis\n* Planned for exploratory laparotomy and primary or interval cytoreductive surgery\n* Preoperative hemoglobin concentration ≥10 mg\u002Fdl within 45 days of surgery\n* Patients scheduled for cytoreductive surgery, with or without other planned procedures o Note: Patients scheduled for only diagnostic laparoscopy should not be included\n\nExclusion Criteria:\n\n* A history of active coronary artery disease\n\n  o Patients with a history of coronary artery disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 45 days of surgery.\n* A history of cerebrovascular disease\n* A history of congestive heart failure\n* A history of uncontrolled hypertension\n* A history of restrictive or obstructive pulmonary disease\n* A history of renal dysfunction (Cr \\>1.6 mg\u002Fdl)\n* Abnormal coagulation parameters (INR \\>1.5 not on coumadin, or platelet count \\\u003C100,000 mcL)\n* Presence of active infection\n* Evidence of hepatic metabolic disorder (bilirubin \\>2 mg\u002Fdl, ALT \\>75 U\u002FL in the absence of biliary tract obstruction)\n* Preoperative autologous blood donation within last 30 days or plan to donate autologous blood prior to surgery\n* Refusal to accept allogenic or autologous blood transfusion\n* Patients scheduled for cytoreductive surgery with planned Hyperthermic Intraperitoneal Chemotherapy (HIPEC)",{"count":629,"type":22},86,[25],"Participants will be scheduled for primary cytoreductive surgery as part of their standard care. Before surgery, participants will be assigned by chance to a study group. Depending on which group they are in, they will receive either acute normovolemic hemodilution\u002FANH during surgery or standard surgical management during surgery. The researchers think acute normovolemic hemodilution\u002FANH may decrease the need for allogenic blood transfusion\u002FABT in people having primary cytoreductive surgery.",[57,633,58,634,635,636,477,478,30,29],"Fallopian Tube Carcinoma","Peritoneal Carcinoma","Ovarian Cancer Stage IIIC","Fallopian Tube Cancer Stage IIIC",[71,638,639,640,394,641,642,643,644,645,646,85,647],"ovarian carcinoma","ovarian cancer stage IIIC","ovarian cancer stage IV","fallopian tube carcinoma","fallopian tube cancer stage IIIC","fallopian tube cancer stage IV","peritoneal cancer","peritoneal carcinoma","Acute Normovolemic Hemodilution","23-392","2026-03-31",{"date":612,"type":35},{"date":651,"type":35},"2024-02-23",{"date":653,"type":22},"2029-02-23",{"name":85,"class":42},{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":23,"phases":663,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":667,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":671,"locationsCount":364},"100445477","early-phase-1-using-aspirin-to-improve-immunological-features-of-ovarian-tumors-100445477","NCT05080946","Using Aspirin to Improve Immunological Features of Ovarian Tumors","Pilot Study to Assess the Efficacy of Aspirin to Improve Immunological Features of Ovarian Tumors","Inclusion Criteria:\n\n* Participants that are greater than or equal to 18 years of age\n* For U.S. sites, patients can read and understand English or Spanish; for Canadian site, participants can read and understand English or French\n* Histology confirmed, or clinical suspicion of, invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma. Must be grade 2 or 3 or high (where high is defined as grade 2\u002F3). All histologies including serous, endometrioid, clear cell sarcoma, or carcinosarcoma histology is acceptable. Mixed histology also acceptable.\n* Treatment naïve for this cancer diagnosis\n* Planned for neoadjuvant chemotherapy (platinum-based doublet with taxane +\u002F- anti-VEGF antibody) for at least 3 but no more than 5 cycles followed by an interval debulking surgery. \\[Note: this study evaluates response while on neoadjuvant treatment. The final collection of specimen and questionnaire is at the time of surgery and immediate post-operative state. Therefore, there are no eligibility criteria related to treatment in the adjuvant setting (e.g., intraperitoneal treatment) and adjuvant therapy should proceed as the physician deems appropriate.\\]\n* Measurable disease as defined by RECIST 1.1, CT scan (with or without contrast) within 12 weeks of study enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2\n* Able to provide tissue biopsy (core or excisional) sufficient for diagnosis and biomarker analysis, may use outside archival tissue if available.\n* If currently using anti-coagulation medication, no contraindication for temporary stoppage of use during the study based on physician judgement\n* Willing and able to swallow pills without difficulty\n* Un-transfused platelet count \\> 100,000 cells\u002FμL\n* Willing and able to participate in all required evaluations and procedures in this study protocol (e.g. undergoing treatment, scheduled visits and examinations, serum testing, questionnaires, pill log\u002Fdiary)\n* Absolute neutrophil count \\> 1.5 x 109 cells\u002FL\n* Hemoglobin \\> 9.0 g\u002FdL, may use transfusions and the value can be post-transfusion\n* Estimated creatinine clearance of \\> 30 mL\u002Fmin, calculated using the formula Cockcroft-Gault \\[(140-age) x Mass (kg)\u002F(72 x creatinine mg\u002FdL)\\] x 0.85 for female\n* No severe hepatic impairment defined as AST or ALT elevation \\\u003C 2.5 x institutional ULN, unless liver metastasis is present \\\u003C 5 x ULN\n\nExclusion Criteria:\n\n* Definite contraindication for either aspirin use or stopping current aspirin use based on physician's clinical judgment\n* History of vascular event in the last 12 months (e.g., myocardial infarction or unstable angina, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant \\[serious or significant\\] arrhythmias, significant vascular disease, congestive heart failure or vascular interventions).\n* History of hypertensive crisis and\u002F or uncontrolled HTN, systolic blood pressure \\> 150 mmHg; diastolic blood pressure \\> 90mmHg. Participants must have blood pressure \\\u003C 150\u002F90 mmHg taken in a clinic setting by a medical professional within 2 weeks prior to starting study.\n* Current or history of ulcers which prohibits aspirin consumption, severe hepatic failure, or acute or chronic renal disease where aspirin use is contraindicated\n* History of gastrointestinal or genitourinary bleeding or other bleeding diathesis or coagulopathy within 6 months prior to enrollment of study\n* Uncontrolled erosive esophagitis requiring 2 or more treatments\n* Other cancer diagnosis in the last 3 years other than non-melanoma skin cancer\n* Autoimmune disorder requiring systemic therapy\n* Chronic steroid use defined as 3 weeks in the past year or any length of time in the past 30 days.\n* Other aspirin or NSAID hypersensitivities or contraindications (e.g. allergy)\n* History of bariatric surgery\n* Currently pregnant at the Screening visit or planning on becoming pregnant during the study period\n* Participant is unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication.\n* Metabolism CYP2C9, known G6PD deficient patients",{"count":169,"type":22},[664],"EARLY_PHASE1","The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma",[57,30,29],{"date":612,"type":35},{"date":669,"type":35},"2021-11-02",{"date":593,"type":22},{"name":672,"class":42},"H. Lee Moffitt Cancer Center and Research Institute",{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":4,"eligibilityCriteria":679,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":680,"targetDuration":4,"studyType":23,"phases":682,"briefSummary":683,"conditions":684,"keywords":689,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":710,"lastUpdatePostDateStruct":711,"startDateStruct":713,"completionDateStruct":715,"leadSponsor":717,"locationsCount":719},"100460887","phase-3-efficacy--safety-of-olvi-vec-and-platinum-doublet--bevacizumab-compared-to-physicians-choice-of-chemotherapy-and-bevacizumab-in-platinum-resistantrefractory-ovarian-cancer-prroc-onprime-gog-3076-100460887","NCT05281471","Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant\u002FRefractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)","A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant\u002FRefractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)","Inclusion Criteria:\n\n* Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer.\n* High-grade serous \\[including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 \\& 3 allowed\\], endometrioid, or clear-cell ovarian cancer.\n* Performance status ECOG of 0 or 1.\n* Life expectancy of at least 6 months.\n* Received a minimum of 3 prior lines (including the 1st line) of systemic therapy with no maximal limit.\n* Platinum-resistant or -refractory disease based on platinum-free interval (PFI) from the last dose of the most recent. platinum-based line of therapy (must have received a minimum of 2 doses of platinum in that line) to subsequent disease progression based on radiological assessment. Platinum-refractory: PFI of \\\u003C 1 month (including disease progression while on platinum-based therapy). Platinum-resistant: PFI of 1-6 months.\n* Received prior bevacizumab (or biosimilar) treatment.\n* No contraindication to receive carboplatin, cisplatin or bevacizumab (or biosimilar).\n* Have disease progression after last prior line of therapy based on radiological assessment prior to randomization.\n* At least 1 measurable target lesion per RECIST 1.1 based on abdominal\u002Fpelvis imaging scan at screening.\n* Evidence by CT and\u002For PET scans or physical exam of abdominal\u002Fpelvis region likely having disease in the peritoneal cavity (i.e., peritoneal carcinomatosis).\n* Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.\n\nExclusion Criteria:\n\n* Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, MMMT tumors absent an epithelial component on recent biopsy, or non-epithelial ovarian cancers (e.g., germ cell tumors, Sex-cord tumors).\n* Bowel obstruction within last 3 months prior to screening.\n* Active urinary tract infection, pneumonia, other systemic infections.\n* Active gastrointestinal bleeding.\n* Known current central nervous system (CNS) metastasis.\n* Inflammatory diseases of the bowel.\n* History of HIV infection.\n* Active hepatitis B virus or hepatitis C virus within 4 weeks prior to study.\n* History of thromboembolic event within the prior 3 months.\n* Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen.\n* Clinically significant cardiac disease at screening (New York Heart Association Class III\u002FIV).\n* Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transient ischemic attack (TIA) in previous 6 months.\n* Oxygen saturation \\\u003C90%.\n* Received prior virus-based gene therapy or therapy with cytolytic virus of any type.\n* Receiving concurrent antiviral agent.\n* Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal\u002Fsquamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, any other stage I\u002FII local malignancies.\n* Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.\n* Underwent surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to first study treatment in either Arm.\n* Receiving immunosuppressive therapy or steroids (except acute concurrent corticosteroid of no more than 20 mg per day for medical management with prednisolone equivalent.\n* Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis \\> once every 14 days.\n* Known hypersensitivity to gentamicin.",{"count":681,"type":22},186,[99],"The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant\u002Frefractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant\u002Frefractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.",[685,686,30,102,687,271,688],"Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Cancer","High-grade Serous Ovarian Cancer","Ovarian Clear Cell Carcinoma",[690,691,692,693,694,695,696,697,698,699,71,394,700,701,702,703,704,705,706,707,708,709],"olvimulogene nanivacirepvec","GL-ONC1","GLV-1h68","oncolytic virus","virotherapy","viral therapy","immunotherapy","immunochemotherapy","combination therapy","vaccinia virus","primary peritoneal cancer","platinum resistant","platinum refractory","recurrent ovarian cancer","platinum resensitization","chemoresistance","heavily pre-treated","immune activation","reversal of platinum resistance or refractoriness","resensitize","2026-03-16",{"date":712,"type":35},"2026-03-18",{"date":714,"type":35},"2022-08-31",{"date":716,"type":22},"2026-10",{"name":718,"class":113},"Genelux Corporation",31]