[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07564141":3,"trial-entities:NCT07564141":136,"trial-summary:NCT07564141":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":58,"secondary_outcomes":62,"sex":85,"minimum_age":86,"maximum_age":87,"healthy_volunteers":88,"eligibility_criteria":89,"std_ages":103,"locations":106,"central_contacts":124,"overall_officials":130,"references":134,"see_also_links":135},"NCT07564141","GCT1184-07","Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer","A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer","RECRUITING","2031-11","2026-08","2026-09-01","2026-08-28","Genmab","INDUSTRY",true,"This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.\n\nThe purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab.\n\nParticipants will receive either:\n\n* Rina-S monotherapy (by itself),\n* Rina-S plus bevacizumab,\n* investigator's choice chemotherapy (by itself) (standard of care), or\n* investigator's choice chemotherapy plus bevacizumab (standard of care).\n\nNo participants will be given placebo. Participants will participate in 1 of 2 arms.\n\nThe treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.\n\nParticipants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective.\n\nThe overall study duration (including screening, treatment, and follow-up) will be different for every participant.","This is a global, open-label, randomized, Phase 3 study of Rina-S ± bevacizumab versus investigator's choice (IC) ± bevacizumab as second-line (2L) treatment in participants with recurrent platinum-sensitive ovarian cancer (PSOC).",[19,20],"Platinum-Sensitive Ovarian Cancer","Ovarian Cancer",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE3",{"count":27,"type":28},688,"ESTIMATED",[30,40,46,49,52,55],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"BIOLOGICAL","Rina-S","Intravenous (IV) infusion",[35],"Arm 1: Rina-S ± Bevacizumab",[37,38,39],"Rinatabart Sesutecan","GEN1184","PRO1184",{"type":41,"name":42,"description":43,"armGroupLabels":44},"DRUG","Bevacizumab","IV infusion",[35,45],"Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab",{"type":41,"name":47,"description":43,"armGroupLabels":48},"Carboplatin",[45],{"type":41,"name":50,"description":43,"armGroupLabels":51},"Gemcitabine",[45],{"type":41,"name":53,"description":43,"armGroupLabels":54},"Paclitaxel",[45],{"type":41,"name":56,"description":43,"armGroupLabels":57},"PLD",[45],[59],{"measure":60,"timeFrame":61},"Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)","Up to approximately 3 years",[63,66,68,70,72,74,76,78,80,83],{"measure":64,"timeFrame":65},"Overall Survival (OS)","Up to approximately 5 years",{"measure":67,"timeFrame":61},"PFS per RECIST v1.1, as Determined by Investigator",{"measure":69,"timeFrame":61},"Objective Response Rate (ORR) per RECIST v1.1",{"measure":71,"timeFrame":61},"Duration of Response (DOR) per RECIST v1.1",{"measure":73,"timeFrame":61},"Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2)",{"measure":75,"timeFrame":61},"Time to First Subsequent Therapy (TFST)",{"measure":77,"timeFrame":61},"Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria",{"measure":79,"timeFrame":61},"Number of Participants with Treatment-emergent Adverse Events (TEAEs)",{"measure":81,"timeFrame":82},"Overall Change from Baseline in Global Health Status (GHS)\u002FQuality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)","Baseline up to approximately 3 years",{"measure":84,"timeFrame":61},"Time to Deterioration (TTD) in the GHS\u002FQoL Score Using the EORTC QLQ C30 Questionnaire","FEMALE","18 Years",null,false,{"inclusion":90,"exclusion":97,"raw_text":102},[91,92,93,94,95,96],"Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.","Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, \\>183 days) after their last dose administration of platinum-based therapy.","Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.","Participants must have measurable disease per RECIST v1.1 by investigator at baseline.","All participants must provide a tumor specimen.","Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.",[98,99,100,101],"Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade\u002Fborderline ovarian tumors.","Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.","Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.","Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα).","Key Inclusion Criteria:\n\n* Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.\n* Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, \\>183 days) after their last dose administration of platinum-based therapy.\n* Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.\n* Participants must have measurable disease per RECIST v1.1 by investigator at baseline.\n* All participants must provide a tumor specimen.\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.\n\nKey Exclusion Criteria:\n\n* Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade\u002Fborderline ovarian tumors.\n* Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.\n* Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.\n* Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα).\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",[104,105],"ADULT","OLDER_ADULT",[107,116],{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":112,"geoPoint":113},"Danbury Hospital","Danbury","Connecticut","06810","United States",{"lat":114,"lon":115},41.39482,-73.45401,{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":112,"geoPoint":121},"ProHealth Care Inc","Waukesha","Wisconsin","53188",{"lat":122,"lon":123},43.01168,-88.23148,[125],{"name":126,"role":127,"phone":128,"email":129},"Genmab Trial Information","CONTACT","+4570202728","clinicaltrials@genmab.com",[131],{"name":132,"affiliation":13,"role":133},"Study Official","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":137,"biomarkers":141},[138,139,140],"Fallopian Tube Carcinoma","Malignant Ovarian Neoplasm","Primary Peritoneal Cancer",[142,143],"BRCA1 Gene","BRCA2 Gene",{"nct_id":4,"found":15,"summary":145,"prompt_version":153},{"design":146,"status":147,"heading":6,"summary":148,"follow_up":146,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"Not specified.","completed","{\n   \"Study of Rina-S for Recurrent Platinum-Sensitive Ovarian Cancer\",\n   \"This study is looking at Rina-S, with or without bevacizumab, as a treatment for recurrent platinum-sensitive ovarian cancer. This is for women whose cancer has returned after initial platinum-based chemotherapy. Researchers want to see how well Rina-S works compared to standard chemotherapy options (investigator's choice of carboplatin, gemcitabine, or paclitaxel), also with or without bevacizumab. You would be randomly assigned to one of these treatment groups. The study aims to measure how long people live without their cancer growing (progression-free survival). This global study plans to enroll up to 688 participants, but its current recruitment status is unclear.\",\n  \"design\": \"This is a global, open-label, randomized Phase 3 study involving up to 688 participants. You would be randomly assigned to one of two treatment arms.\",\n  \"commitments\": \"Participants will receive Rina-S, Rina-S plus bevacizumab, standard chemotherapy, or standard chemotherapy plus bevacizumab. The duration of treatment will vary for each participant.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Your progression-free survival will be measured for up to approximately 3 years.\",\n}",178,"Not specified in the trial record.","Not stated in the trial record.",[32,42,47,50,53],"v2"]