[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-grade-serous-ovarian-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-grade-serous-ovarian-cancer":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,62,101,153,178,227,256,284,316,341,368],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100439677","phase-1-study-to-assess-adverse-events-and-pharmacokinetics-in-adult-participants-with-non-small-cell-lung-cancer-head-and-neck-squamous-cell-carcinoma-and-other-solid-tumors-receiving-intravenous-infusion-of-azirkitug-alone-or-in-combinations-with-budigalimab-bevacizumab-or-telisotuzumab-adizutecan-100439677",false,"NCT05005403","Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan","A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors With Azirkitug as a Single Agent and in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan","Inclusion Criteria:\n\n* Pre Treatment biopsy or archive tissue within 6 months without intervening treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of \\\u003C= 0 or 1 and a life expectancy of \\>= 3 months.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)\n* Laboratory values meeting criteria outlined in the protocol\n* NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination). Actionable gene alterations are eligible if failed targeted therapeutic options.\n* HSNCC - Advanced\u002Fmetastatic progressed on platinum and PD-1\u002FPD-LI in recurrent or metastatic setting.\n* Micro Satellite Stable Colorectal Cancer (MSS-CRC) - Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, BRAFV600E or HER2, other targetable mutations targeted with locally approved therapy, TAS-102, Regorafenib and not MSI-h or MMR-deficient\n* Gastric and Gastroesophageal Junction adenocarcinoma (GEA) - Advanced\u002Fmetastatic progressed on at least 1 prior cytotoxic chemotherapeutic regimen and if applicable immune checkpoint inhibitor and\u002For HER2 therapy\n* High-Grade Serous Ovarian Cancer (HGSOC) - Progressed serous epithelial ovarian, fallopian tube or primary peritoneal cancer post SOC and not eligible for surgical resection. Platinum resistant cannot have \\>5 lines of prior therapy.\n* Pancreatic Adenocarcinoma (PDAC) - Advanced\u002Fmetastatic progressed after SOC. Includes adenosquamous carcinoma and post-Whipple.\n* Triple Negative Breast Cancer (TNBC) - Progressed after 1 or 2 systemic therapy that must have included taxane and treatment naïve to immunotherapy targeting T-cell co-stimulation\n\nExclusion Criteria:\n\n* Pancreatic Ductal Adenocarcinoma (PDAC) - Excludes neuroendocrine or acinar pancreatic carcinoma and participants with coagulopathy or at risk of or history of Deep vein thrombosis (DVT)\u002FPE\n* No major surgery within 28 days prior to dosing\n* No active autoimmune\u002Fimmunodeficiency disease with limited exceptions\n* Combination treatment excludes participants treated with anti-programmed cell death protein 1(PD-1)\u002FProgrammed cell death ligand 1 (PD-L1) who had immune mediated toxicity G3 or greater, interstitial lung disease, or hypersensitivity Combination treatment may also require no significant cardiac deficiencies and\u002For events\n* Pregnancy\n* Excluded medications include anticancer therapy within 5 half-live or 28 days (whichever is shorter), agent targeting Chemokine Receptor (CCR)8, live vaccines, immunosuppressive medication with limited exceptions","ALL","18 Years",{"count":19,"type":20},694,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of azirkitug as a monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan.\n\nBevacizumab is an approved product, while budigalimab, azirkitug, and telisotuzumab adizutecan are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The maximum-tolerated dose (MTD)\u002Fmaximum administered dose (MAD) of azirkitug will be explored. Each treatment arm receives a different dose of azirkitug in monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Approximately 694 adult participants will be enrolled in the study across approximately 80 sites worldwide.\n\nParticipants will receive azirkitug as a monotherapy or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 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. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[26,27,28,29,30,31,32],"Non-Small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Micro Satellite Stable Colorectal Cancer","Gastric\u002FEsophageal Cancer","High-Grade Serous Ovarian Cancer","Pancreatic Cancer","Triple Negative Breast Cancer",[26,34,27,35,36,37,38,39,28,40,41,42,43,30,44,45,32,46,47,48],"NSCLC","HNSCC","Solid Tumors","Budigalimab","ABBV-181","ABBV-514","MSS-CRC, Gastric Cancer","Esophageal Cancer","GEA","GEJ","HGSOC","Pancreatic Cancer, PDAC","TNBC","Telisotuzumab Adizutecan","ABBV-400","RECRUITING","2026-06-19",{"date":52,"type":53},"2026-06-23","ACTUAL",{"date":55,"type":53},"2021-11-01",{"date":57,"type":20},"2027-07",{"name":59,"class":60},"AbbVie","INDUSTRY",48,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":72,"conditions":73,"keywords":80,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100631678","phase-1-a-study-of-ide034-in-adult-participants-with-locally-advancedmetastatic-solid-tumors-types-100631678","NCT07503808","A Study of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors Types","An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Participant must be at least 18 years of age or the age of maturity per local regulations\n2. Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 \\[HER2\\] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies.\n3. Archival tissue sample for testing\n4. Measurable disease\n5. Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n6. Have adequate bone marrow and organ function.\n7. Able to comply with contraceptive\u002Fbarrier requirements\n\nExclusion Criteria:\n\n1. Known symptomatic brain metastases or leptomeningeal metastasis\n2. Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.\n3. Have uncontrolled tumor-associated pain\n4. Have clinically significant cardiac abnormalities and\u002For cerebrovascular disease (stroke) within 6 months before the first dose\n5. Active uncontrolled infection\n6. Have history of interstitial pneumonitis, current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose.\n7. Have history of severe infections within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization.\n8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening.\n9. Participants with known or suspected viral hepatitis\n10. Have history of active tuberculosis within 1 year before enrollment\n11. If participants had adverse reactions to previous antitumor treatment that have not recovered to guidelines of CTCAE Grade ≤ 1 and Grade 2 peripheral neurological symptoms\n12. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 3 weeks before the first dose of IMP or other investigational products within 4 weeks of first dose of IMP\n13. Administration of any of the following\n\n    1. Current use or anticipated need for food or drugs that are known strong CYP3A4\u002F5 inhibitors or inducers\n    2. Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC).\n    3. Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP\n    4. Have received radiotherapy within 2 weeks prior to study entry\n    5. Have undergone major surgery or trauma within 4 weeks prior to study entry.\n    6. Have received live attenuated vaccine within 28 days prior to the first dose or are expected to receive live attenuated vaccine during the study treatment.\n    7. Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP.\n    8. Are known to be allergic to any component or excipient of the IMP product or have a history of severe allergic reactions to other monoclonal antibody\u002Ffusion protein drugs.\n    9. Participants with complications in the eye including ulcers in the eye, and severe dry eye",{"count":70,"type":20},150,[23],"This is a Phase 1a\u002F1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced\u002Fmetastatic solid tumor types that express B7-H3 and PTK7.",[74,75,27,76,77,78,79,32],"Esophageal Squamous Cell Carcinoma","High Grade Serous Ovarian Cancer","Colorectal Cancer","Castration-resistant Prostate Cancer","Non Small Cell Lung Cancer","Endometrium Cancer",[74,81,82,27,35,83,46,76,84,77,85,86,34,87,44,88,89,90],"ESCC","Endometrial Cancer","Triple-negative Breast Cancer","CRC","CRPC","Non-small Cell Lung Cancer","High-grade Serous Ovarian Cancer","Advanced, Metastic Solid Tumors","B7-H3 (CD276) and Protein Tyrosine Kinase 7 (PTK7)","IDE034","2026-06-16",{"date":93,"type":53},"2026-06-18",{"date":95,"type":53},"2026-02-24",{"date":97,"type":20},"2027-07-30",{"name":99,"class":60},"IDEAYA Biosciences",15,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":113,"conditions":114,"keywords":126,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"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":110,"type":20},884,[23,112],"PHASE2","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).",[115,75,116,117,82,86,118,119,120,32,121,122,123,124,125],"High Grade Epithelial Ovarian Cancer","Primary Peritoneal Carcinoma","Fallopian Tube 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","Uterine Cancer",[127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142],"antibody-drug conjugate","folate receptor alpha","folate receptor","solid tumor","ovarian cancer","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","2026-06-01",{"date":145,"type":53},"2026-06-03",{"date":147,"type":53},"2022-12-07",{"date":149,"type":20},"2027-10",{"name":151,"class":60},"Genmab",66,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":160,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":163,"phases":4,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":177},"100441397","ctdna-as-a-novel-biomarker-of-treatment-efficacy-in-patients-with-ovarian-cancer-100441397","NCT05027828","CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer","Circulating Tumor DNA as a Novel Molecular Marker of Treatment Efficacy to Guide Targeted Maintenance Therapy for Patients With High Grade Serous Ovarian Cancer","Inclusion Criteria:\n\n1. Ovarian cancer first diagnosed and treated;\n2. Pathologically confirmed as epithelial ovarian cancer\u002Ffallopian tube cancer\u002Fprimary peritoneal cancer;\n3. The stage of the disease is II-IV, and surgery will be performed after evaluation;\n4. Age ≥ 18 years old;\n5. Subjects and their families fully understand the research plan and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Pathologically confirmed as non-epithelial ovarian cancer;\n2. Surgical treatment cannot be performed after evaluation;\n3. Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment;\n4. Patients who do not agree to use clinical first-line targeted drugs;\n5. Severe mental illness;\n6. Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases.","FEMALE",{"count":162,"type":20},100,"OBSERVATIONAL","This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.",[87,166],"Circulating Tumor DNA","2026-04-22",{"date":169,"type":53},"2026-04-24",{"date":171,"type":53},"2021-09-01",{"date":173,"type":20},"2027-09-30",{"name":175,"class":176},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",1,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":160,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":189,"conditions":190,"keywords":196,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"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":186,"type":20},186,[188],"PHASE3","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.",[191,192,117,193,87,194,195],"Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Cancer","Primary Peritoneal Cancer","Endometrioid Ovarian Cancer","Ovarian Clear Cell Carcinoma",[197,198,199,200,201,202,203,204,205,206,131,133,207,208,209,210,211,212,213,214,215,216],"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":219,"type":53},"2026-03-18",{"date":221,"type":53},"2022-08-31",{"date":223,"type":20},"2026-10",{"name":225,"class":60},"Genelux Corporation",31,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":160,"minAge":17,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":163,"phases":4,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":246,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":4},"100613667","impact-of-dietary-patterns-on-prognosis-of-ovarian-cancer-patients-during-parpi-maintenance-100613667","NCT07269574","Impact of Dietary Patterns on Prognosis of Ovarian Cancer Patients During PARPi Maintenance","A Multicenter, Retrospective Clinical Study Evaluating the Effect of Different Dietary Patterns on the Prognosis of Ovarian Cancer Patients During PARPi Maintenance Therapy","Inclusion Criteria:\n\n* Female patients aged 18 to \\\u003C75 years.\n* Histologically or cytologically diagnosed with primary high-grade serous ovarian cancer (HGSOC), fallopian tube cancer, or primary peritoneal cancer.\n* Received initial tumor cytoreductive surgery (Primary Debulking Surgery or Interval Debulking Surgery) and first-line platinum-based chemotherapy, achieving Complete Response (CR) or Partial Response (PR).\n* Received PARP inhibitors as maintenance therapy for the first time following the completion of first-line treatment.\n* Complete clinical data available in the electronic medical records, including baseline characteristics, first-line treatment details, PARPi maintenance therapy information, and prognostic follow-up data.\n* The patient (or primary caregiver) has normal communication abilities, voluntarily agrees to participate, and is able to cooperate in completing the retrospective Food Frequency Questionnaire (FFQ).\n\nExclusion Criteria:\n\n* Clinical diagnosis only, without pathological or cytological confirmation.\n* Non-high-grade serous histological subtypes (e.g., ovarian clear cell carcinoma, endometrioid carcinoma, mucinous carcinoma, low-grade serous carcinoma).\n* Secondary or metastatic ovarian cancer (malignancy originating from other organs).\n* Severe deficiency of key clinical or prognostic information that prevents assessment of the primary endpoint.\n* Inability to accurately recall dietary information due to cognitive impairment, mental illness, or other reasons.\n* Presence of severe metabolic or digestive system diseases during PARPi maintenance therapy that required specific restricted diets (e.g., insulin-dependent diabetes, dialysis-dependent renal insufficiency, short bowel syndrome, active Crohn's disease).\n* Occurrence of significant physiological events during the study period that significantly altered dietary structure (e.g., major gastrointestinal surgery).","75 Years",{"count":236,"type":20},600,"The goal of this retrospective observational study is to evaluate the relationship between different dietary patterns (specifically low-carbohydrate diets) and the prognosis of patients with high-grade serous ovarian cancer (HGSOC) receiving first-line PARP inhibitor (PARPi) maintenance therapy. The main questions it aims to answer are:\n\n* Is there an association between dietary patterns and patients' Progression-Free Survival (PFS)?\n* Is there an association between dietary patterns and Overall Survival (OS)? This is a multicenter, retrospective cohort study. Researchers will review electronic medical records from 14 tertiary hospitals in China to identify women who received first-line PARP inhibitor maintenance for advanced high-grade serous ovarian cancer between 2020 and 2025, and collect information on baseline characteristics, treatments and follow-up outcomes.\n\nResearchers will compare patients with a \"low-carbohydrate diet pattern\" to those with a \"regular\u002Fhigh-carbohydrate diet pattern\" to see if there are differences in treatment outcomes and survival.\n\nParticipants will:\n\n* Have their clinical, pathological, and treatment data collected from electronic medical records.\n* Complete a retrospective Food Frequency Questionnaire (FFQ) via phone or clinic visit to recall their dietary habits during the maintenance treatment period.\n* Optionally provide a blood sample for nutrition and metabolic analysis. (For participants at the main study center only) No experimental drugs or specific diets will be given in this study. All anti-cancer treatments are decided by the treating physicians as part of routine clinical care.",[239,240,116,87],"Ovarian Cancer","Fallopian Tube Cancers",[239,30,242,243,244,245],"PARP Inhibitor","Maintenance Therapy","Dietary Pattern","Low-Carbohydrate Diet","NOT_YET_RECRUITING","2025-11-26",{"date":249,"type":53},"2025-12-08",{"date":251,"type":20},"2025-11-27",{"date":253,"type":20},"2026-12-31",{"name":255,"class":176},"Tongji Hospital",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":268,"conditions":269,"keywords":273,"overallStatus":246,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":4},"100613582","minimal-residual-disease-in-solid-malignancies-100613582","NCT07268469","Minimal Residual Disease in Solid Malignancies","Interception of Minimal Residual Disease in Solid Malignancies","IMRD","Inclusion Criteria:\n\n* Provision of informed consent\n* Age ≥18 years\n* Eligibility for potentially-curative surgery, regardless of previous neoadjuvant\u002Fpre-operative systemic treatment\n* Completed adequate pre-surgical staging procedures as per standard clinical practice\n* Diagnosis of one of the following:\n* Clinical Stage II or III breast cancer\n* Clinical Stage II or III NSCLC\n* HGSOC, either relapsed after primary treatment, confirmed by biopsy, or suspected on the basis of radiological criteria\n* Prostate cancer, with at least one of the following: Gleason Score ≥8, radiologically ≥cT2c, or PSA \\>10\n* Gastric cancer with at least one of the following: Radiological\u002Fecoendoscopic\u002Flaparoscopic evidence of node-positive disease, infiltration of the serosa or the surrounding organs, diffuse subtype as histology.\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Unable to undergo surgery\n* Radiological evidence of metastatic disease\n* Unwilling to be subjected to longitudinal plasma samples collection\n* Prior diagnosis of a malignant tumor for which the patients underwent any type of anti-neoplastic treatment within 2 years prior to the study screening",{"count":265,"type":20},840,[267],"NA","The IMRD study is a single-centre, prospective observational study which will investigate the rate of ctDNA (circulating tumor DNA) detection from the start of adjuvant therapy following curative-intent surgery. The study will include patients of age 18 years old or older, who provided informed consent. Eligible patients are affected by one of the following non-metastatic resected tumors: i) breast cancer (BC), ii) non-oncogene addicted (EGFR\u002FALK-wild type) non-small-cell lung cancer (NSCLC), iii) high-risk and very high-risk prostate cancer, iv) high-grade serous ovarian cancer (HGSOC), and v) gastric cancer. Eligible patients will undergo surgery and receive adjuvant treatment(s) as per standard guidelines. Patients who underwent neoadjuvant treatments and had a complete pathological response (i.e., no residual tumor at surgery following neoadjuvant treatments) will not be eligible for the present study.\n\nDuring adjuvant treatment and following its conclusion, patients will be subjected to instrumental monitoring, as per standard guidelines and clinical practice. For eligible patients, a baseline plasma sample will be collected at the time of surgery (feasibility window) and prior to the start of adjuvant treatments (not prior to 28 from the date of surgery) for assessing the detection of ctDNA. Afterwards, plasma samples will be collected at 3, 6 and 9 months from the start of postoperative adjuvant treatments. For patient specific monitoring, a tumor-informed targeted sequencing panel, using tumor-specific mutations detected with WES, will be employed to gather the most sensitive diagnostic platforms, mitigating the risk of negative cases. At 6 months or upon positive ctDNA detection, either a thoracic-abdominal-pelvic or total-body CT scan will be performed to exclude the presence of overt metastatic disease. All patients included in the study will be monitored with longitudinal ctDNA assessment until one-year or follow-up or until the radiological detection of metastatic disease, whichever will occur first. Additional follow-up will be carried outside the IMRD study and will follow standard clinical protocols and schedules. Being an observational study, no treatment intervention will be applied as per protocol based on the detection or absence of ctDNA. For conducting exploratory analyses, the primary tumors will be retrieved and subjected to WES, and the study will aim to detect molecular tumor variables associated with a lack of ctDNA clearance following curative-intent treatment interventions.\n\nThe study will be conducted in 2 phases. The first phase aims at verifying the feasibility and sustainability of such approach, based on the identification of at least 15% positive patients. This phase is predicted to be completed within 2 years, and is the object of the present application. If the first endpoint is achieved, we will expand the study to include the co-primary endpoint, which aims at estimating the fraction of patients with persistent ctDNA 6 months post-surgery despite adjuvant therapy.",[270,78,271,75,272],"Breast Cancer","Prostate Cancer","Gastric Cancer",[274],"ctDNA","2025-11-25",{"date":277,"type":53},"2025-12-05",{"date":279,"type":20},"2025-12",{"date":281,"type":20},"2033-07",{"name":283,"class":176},"European Institute of Oncology",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":160,"minAge":17,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":302,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":315},"100478610","phase-2-a-phase-2-study-of-avutometinib-vs-6766-plus-defactinib-100478610","NCT05512208","A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib","A Phase 2 Study of VS-6766 (Dual RAF\u002FMEK Inhibitor) Plus Defactinib (FAK Inhibitor) in Recurrent Gynecological Cancers (DURAFAK)","DURAFAK","Inclusion Criteria:\n\n1. Female subjects ≥ 18 years of age.\n2. Histologically proven gynecological cancers (endometrioid, MOC, HGSOC and solid gynecological cancers) with mutated RAS, BRAF (type I, II, and\u002For III), NF-1 loss of function, and\u002For RAS activation.\n\n   1. Mutational status will be taken from the previous next-gen sequencing (NGS) or molecular testing results and reviewed by the Principal Investigator prior to the start of treatment.\n   2. Adequate pathology material (as defined in the lab manual) must be available prior to treatment assignment to be used for confirmation.\n3. Tumor with known RAS mutation, BRAF (type I, II, and\u002For III) mutation, NF-1 and\u002For RAS activation status determined from previous NGS or molecular testing. Adequate archival tumor tissue less than 5 years old or fresh biopsy tissue samples (as defined in the lab manual) must be available.\n4. Progression (radiographic or clinical) or recurrence of gynecological cancer after at least one prior systemic therapy for metastatic disease. Below are additional prior treatments that are allowed once the requirement of prior platinum therapy is satisfied.\n\n   a. Prior systemic therapy for metastatic disease (FIGO stage II-IV) may consist of chemotherapy administered as single agent or a platinum or another chemotherapy doublet with or without bevacizumab, with or without maintenance therapy or radiation therapy; and\u002For hormonal therapy.\n5. Measurable disease according to RECIST 1.1.\n6. An Eastern Cooperative Group (ECOG) performance status ≤ 2.\n7. Must have adequate organ function defined by the following laboratory parameters:\n\n   1. Adequate hematologic function including: hemoglobin \\[Hb\\] ≥9.0 g\u002FdL; platelets ≥100,000\u002Fmm3; and absolute neutrophil count \\[ANC\\] ≥1500\u002Fmm3). If a red blood cell transfusion has been administered the Hb must remain stable and ≥9 g\u002FdL for at least 1 week prior to first dose of study therapy.\n   2. Adequate hepatic function: (i) total bilirubin ≤1.5 × upper limit of normal \\[ULN\\] for the institution; subjects with Gilbert syndrome may enroll if total bilirubin is \\\u003C3.0 mg\u002FdL (51 μmole\u002FL) upon discussion with the Principal Investigator (PI). (ii) alanine aminotransferase (ALT) and alanine aminotransferase (AST) ≤2.5 × ULN (or \\\u003C5x ULN in subjects with liver metastases).\n   3. Adequate renal function with creatinine clearance rate of ≥50 mL\u002Fmin as calculated by the Cockcroft-Gault formula or serum creatinine of ≤ 1.5 x ULN.\n   4. International normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) ≤ 1.5 x ULN in the absence of anticoagulation or therapeutic levels in the presence of anticoagulation.\n   5. Albumin ≥3.0 g\u002FdL (451 μmole\u002FL).\n   6. Creatine phosphokinase (CPK) ≤2.5 x ULN.\n   7. Adequate cardiac function with left ventricular ejection fraction ≥ 55% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.\n8. Baseline QTc interval \\\u003C 460 ms (average of triplicate readings) (CTCAE Grade1) using Fredericia's QT correction formula. NOTE: This criterion does not apply to subjects with a right or left bundle branch block.\n9. Adequate recovery from toxicities related to prior treatments to at least Grade 1 by CTCAE v 5.0\n10. Exceptions include alopecia and peripheral neuropathy Grade ≤2. Subjects with other toxicities that are stable on supportive therapy may be allowed to participate with prior approval by the Sponsor.\n11. Females with reproductive potential and their male partners agree to use highly effective method of contraceptive (per recommendations in Section 13.4) during the trial and for 1 month following the last dose of Avutometinib for female patients.\n\nExclusion Criteria:\n\n1. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.\n2. Prior MEKi or RAFi exposure.\n3. Low grade serous ovarian cancer (LGSOC).\n4. History of prior malignancy with recurrence \\\u003C3 years from the time of enrollment. Subjects with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, and in situ cervical cancer that has undergone potentially curative therapy with no evidence of disease recurrence for ≥1 year since completion of the appropriate therapy may be included. Subjects with other malignancies associated with very low risk of metastasis or death may be included upon discussion with the PI.\n5. Subjects who are deemed in the opinion of their treating physician to be appropriate candidates for a debulking surgery. These subjects should preferentially receive surgery prior to consideration of trial therapy.\n6. Major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 1 week (7 days) of the first dose of study therapy.\n7. Treatment with warfarin. Subjects on warfarin for DVT\u002FPE can be converted to low-molecular weight heparin (LMWH) or direct oral anticoagulants (DOACs).\n8. Exposure to strong CYP2C9 and CYP3A4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy. See Table 14 and Table 15 for representative lists of CYP inhibitors and inducers. For additional guidance, see https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions-table-substrates-inhibitors-and-inducers.\n9. Exposure to P-glycoprotein (P-gp) inhibitors or inducers within 14 days prior to the first dose and during the course of the study. See Table 16 for a representative list of P-gp inhibitors and inducers.\n10. Symptomatic brain metastases requiring steroids or other interventions. These metastases may manifest as altered mental status, persistent headaches, persistent nausea, focal weakness or numbness, and seizures. Subjects 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 entry, have discontinued corticosteroid treatment for these metastases for at least 2 weeks prior to first dose of study therapy, and are neurologically stable, with no evidence of interim progression. Subjects with new asymptomatic CNS metastases detected during the screening period must receive radiation therapy and\u002For surgery for CNS metastases. Following treatment, these subjects may then be eligible if all other criteria are met.\n11. Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy.\n12. Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection that is active and\u002For requires therapy.\n13. Active skin disorder that has required systemic therapy within the past year.\n14. History of rhabdomyolysis.\n15. Concurrent ocular disorders:\n\n    1. Subjects with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes.\n    2. Subject with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \\> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO.\n    3. Subjects with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions.\n16. Concurrent congestive heart failure, prior history of class III\u002F IV cardiac disease (New York Heart Association \\[NYHA\\]), myocardial infarction within the last 6 months, unstable arrhythmias, unstable angina, or severe obstructive pulmonary disease.\n17. Subjects with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or active inflammatory bowel disease.\n18. Subjects with a history of hypersensitivity to any of the active or inactive Avutometinib ingredients (hydroxypropylmethylcellulose, mannitol, magnesium stearate) of the investigational product.\n19. Female subjects who are pregnant or breastfeeding.\n20. Any other medical condition (e.g. cardiac, gastrointestinal, pulmonary, psychiatric, neurological, genetic, etc.) that in the opinion of the investigator would place the subject at unacceptably high risk for toxicity.","99 Years",{"count":294,"type":20},55,[112],"The purpose of this research is to test the effectiveness and safety of the study drugs (VS-6766 and defactinib), and see what effects (good and bad) these drugs have on the patients with endometrioid cancer, mucinous ovarian cancer, high-grade serous ovarian cancer, or solid gynecological cancer.",[298,299,75,300,301],"Endometrioid Cancer","Mucinous Ovarian Cancer","Cervical Cancer","Solid Tumor",[303,304,305],"Avutometinib","defactinib","VS-6766","2025-10-20",{"date":308,"type":53},"2025-10-22",{"date":310,"type":53},"2023-02-06",{"date":312,"type":20},"2029-12",{"name":314,"class":176},"University of Oklahoma",4,{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":160,"minAge":17,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":326,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":338,"locationsCount":340},"100591166","phase-1-investigating-idetrexed-and-olaparib-in-patients-with-ovarian-cancer-100591166","NCT06976892","Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer","A Phase I\u002FIb Trial of Idetrexed (Alpha Folate Receptor Targeted Thymidylate Synthase Inhibitor) in Combination With Olaparib (a PARP Inhibitor) at Different Doses in Patients With Ovarian Cancer (IDOL)","IDOL","Inclusion Criteria:\n\n* Histologically or cytologically proven high grade serous ovarian cancer refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.\n* Measurable (as defined by RECIST v1.1) or evaluable (based on tumour markers) disease.\n* Life expectancy of at least 12 weeks.\n* World Health Organisation (WHO) performance status of 0-1 (Appendix 1 of Protocol).\n* Haematological and biochemical indices within the ranges shown in Protocol section 4.1.1). These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP.\n\nNormal (no clinically significant abnormalities) 12-lead ECG, QTcF interval \\\u003C470 ms\n\n* Pulmonary function test FVC of \\>70%, DLCOc (DLCO corrected for Hb) of \\>60%.\n* 18 years or over.\n* Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.\n* For dose expansion patients only, they must have medium to high α-folate receptor expression according to the Ventana FOLR1-2.1 IHC assay.\n\nExclusion Criteria:\n\n* Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and 4 weeks for investigational medicinal products) before treatment.\n* Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the DDU should not exclude the patient.\n* Patients with new brain metastases. Patients with treated (surgically excised or irradiated) and stable brain metastases are eligible as long as the treatment was at least 4 weeks prior to initiation of study drug and brain MRI within 2 weeks of initiation of study drug is negative for new metastases.\n* Patients with pulmonary metastases.\n* History of thoracic radiation or other history likely to create pre-existing lung disease\n* Presence of significant clinical ascites and\u002For pleural effusions.\n* Female patients of child-bearing potential (or are already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) \\[oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom\\] or agree to sexual abstinence (see Protocol Section 16.5 - Appendix 5), effective from signing the consent form, throughout the trial and for six months afterwards are considered eligible.\n* Major thoracic or abdominal surgery from which the patient has not yet recovered.\n* Patients with sub-acute bowel obstruction.\n* Organ transplant patients.\n* At high medical risk because of non-malignant systemic disease including active uncontrolled infection.\n* Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n* Patients with history of QT prolongation, clinically significant VT, VF, heart block, MI within 1 year, CHF NYHA Class III or IV, unstable angina, angina within 6 months, or other evidence of clinically significant coronary artery disease\u002F\n* Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I\u002FIb study of Idetrexed and Olaparib. Participation in an observational trial would be acceptable.\n* Inability to tolerate Olaparib.\n* Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.\n* Confirmed, current COVID-19 infection.",{"count":325,"type":20},33,[23],"Two drugs called Idetrexed and olaparib are being evaluated. Idetrexed is a type of drug called an \"aFR-targeted thymidylate synthase inhibitor\". Idetrexed has been designed to selectively target cancer cells that have a protein called folate receptor on the surface of cancer cells. Thymidylate synthase is key to cancer cells for creating new DNA when they multiply. Blocking the action of thymidylate synthase with a drug like Idetrexed may therefore stop cancers from growing by damaging DNA in cancer cells. Olaparib is a type of drug called a \"PARP inhibitor\". It prevents cells repairing DNA damage. This leads to cells dying. Combining Idetrexed and olaparib should increase the number of cancer cells dying, especially those cells that have a lot of folate receptors. Cancer cells with a high number of folate receptors should be targeted more than normal healthy cells.",[75],[239,330,331],"idetrexed","olaparib","2025-08-12",{"date":334,"type":53},"2025-08-13",{"date":336,"type":20},"2025-08",{"date":312,"type":20},{"name":339,"class":176},"Institute of Cancer Research, United Kingdom",3,{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":160,"minAge":17,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":351,"conditions":352,"keywords":353,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":177},"100522559","unravelling-tumour-biology-in-ovarian-cancer-with-precision-imaging-100522559","NCT06084195","Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging","MR-O-MICS","Inclusion Criteria:\n\n* Patient aged \\>18\n* Pathologically proven HGSOC at an advanced stage (FIGO IIIB or IIIC) which can benefit from surgery with or without prior neoadjuvant treatment\n* Willingness and ability to comply with planned visits, treatment plan, laboratory tests and other study procedures,\n* Patient who has given informed, written and express consent,\n* Patient affiliated with a French health insurance scheme.\n\nExclusion Criteria:\n\n* Early-stage disease (FIGO \\\u003CIIIB) or presence of extraperitoneal metastases,\n* Patient who will not have surgery\n* Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,\n* Patient under guardianship, curatorship or safeguarding of justice,\n* Pregnant and\u002For nursing patient,\n* Patient with a history of other cancers within 5 years\u002F10 years prior to inclusion",{"count":349,"type":20},120,[267],"The objective of this study is to explore the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cance",[75],[354,355,356,357,358],"Radiomics","Ovarian cancer","Genomics","Proteomics","Immune Tumor Microenvironment","2025-02-11",{"date":361,"type":53},"2025-02-12",{"date":363,"type":53},"2023-12-19",{"date":365,"type":20},"2029-10",{"name":367,"class":176},"Institut du Cancer de Montpellier - Val d'Aurelle",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":11,"sex":160,"minAge":17,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":163,"phases":4,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":177},"100575807","role-of-rpl8-protein-alterations-in-high-grade-serous-ovarian-carcinoma-100575807","NCT06777082","Role of RPL8 Protein Alterations in High-grade Serous Ovarian Carcinoma","Ruolo Delle Alterazioni Della Proteina RPL8 Nel Carcinoma Ovarico Sieroso ad Alto Grado","OVCAR","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of high-grade (3 or 4) serous ovarian carcinoma, either at onset or recurrence.\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Ovarian tumors of histological types other than serous.\n* Other primary tumor types.",{"count":70,"type":20},"Background and rationale of the study:\n\nFrom our preliminary analyses of a dataset on patients with high-grade serous ovarian carcinoma (HGSOC), available in the online database The Cancer Genome Atlas, we found that the gene encoding ribosomal protein L8 (RPL8) is amplified at a high frequency (\\~30%) in HGSOC. Moreover, its mRNA expression is positively correlated with its genetic amplification-an observation not previously reported or studied in the literature. RPL8 is a structural component of the large ribosomal subunit, which is involved in protein synthesis. Based on this, and our preliminary data, we hypothesize that RPL8 amplification may play a role in ovarian cancer development. Understanding the impact of RPL8 amplification in ovarian cancer could provide new insights into the biology of this poorly understood cancer.\n\nStudy objectives:\n\nThe main objective of this project is to determine whether RPL8 can be used as a biomarker both for risk assessment and for patient stratification in choosing the most appropriate therapeutic option. Specifically, we aim to study:\n\n1. The relationship between the genetic status of RPL8 and clinical outcomes.\n2. The contribution of RPL8 amplification to treatment response.\n\nType of human tissue under study:\n\nThe analyses will be conducted on tumor tissue samples obtained from ovarian cancer resections. Some samples have already been collected and stored at the IRCCS, while others are yet to be gathered.\n\nType of investigation:\n\n* Expression analysis of RPL8, C-MYC, and related genes (RT-PCR, ddPCR, WB, IHC).\n* Gene copy number analysis and mutation screening (ddPCR and similar molecular techniques).\n* Analysis of possible associations between pathological data, follow-up data, and therapeutic response outcomes in patients.\n\nAnalysis methodology:\n\nData on the genetic status, expression, and subcellular localization of RPL8 and C-MYC will be correlated with categorical and continuous variables related to the patients' medical history and clinical status. Differences between categorical variables will be analyzed using analysis of variance (ANOVA), the Mann-Whitney test, or the Kruskal-Wallis test, depending on whether data distribution is normal or not (assessed via the Kolmogorov-Smirnov test). Correlations between continuous variables will be evaluated using Pearson or Spearman tests, again based on data distribution.",[75],"2025-01-10",{"date":381,"type":53},"2025-01-15",{"date":383,"type":53},"2024-03-20",{"date":385,"type":20},"2025-08-30",{"name":387,"class":176},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]