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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522167-15-00 | EU Trial (CTIS) Number | ||
| jRCT2051250197 | Registry Identifier | Japan Registry for Clinical Trials (jRCT) | |
| GOG-3134 | Other Identifier | Other Sponsor Identifier | |
| ENGOT-OV96 | Other Identifier | Other Sponsor Identifier |
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This Phase 3 study will be conducted in different countries around the world with up to about 528 participants.
The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with available standard of care therapy that is already approved and used for ovarian cancer.
Participants will receive either Rina-S monotherapy (by itself), Rina-S plus bevacizumab, bevacizumab (standard of care) by itself, or no treatment (only monitoring, also standard of care). No participants will be given placebo. Participants will participate in 1 of 2 arms.
The 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.
Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 weeks). 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. The overall study duration (including screening, treatment, and follow-up) for each participant will be different for every participant.
This is a randomized, open-label, Phase 3 study of Rina-S + standard of care (SOC) versus SOC as maintenance treatment after second-line (2L) platinum-based doublet chemotherapy in participants with recurrent PSOC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rina-S + SOC | Experimental | Participants will receive Rina-S and SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation). |
|
| SOC | Active Comparator | Participants will receive SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rina-S | Drug | Intravenous (IV) infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by Investigator Assessment | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Up to approximately 4 years | |
| PFS, per RECIST 1.1, as Determined by Blinded Independent Central Review | Up to approximately 3 years | |
| Second Determination of PFS (PFS2) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Genmab Trial Information | Contact | +4570202728 | clinicaltrials@genmab.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Official | Genmab | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mt. Sinai Comprehensive Cancer Center | Recruiting | Miami | Florida | 33140 | United States | |
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| Bevacizumab | Drug | IV infusion |
|
| Up to approximately 4 years |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to approximately 4 years |
| Overall Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Questionnaire | Up to approximately 4 years |
| Time to Deterioration (TTD) in the GHS/QoL Score Using the QLQ-C30 | Up to approximately 4 years |
| Sarasota Memorial Health Care System |
| Recruiting |
| Sarasota |
| Florida |
| 34239 |
| United States |
| Miami Valley Hospital South | Recruiting | Centerville | Ohio | 45459 | United States |
| Zangmeister Cancer Center | Recruiting | Columbus | Ohio | 43219 | United States |
| National Hospital Organization Hokkaido Cancer Center | Recruiting | Sapporo | Hokkaido | Japan |
| Sapporo Medical University Hospital | Recruiting | Sapporo | Hokkaido | Japan |
| Hyogo Cancer Center | Recruiting | Akashi | Hyōgo | Japan |
| Mie University Graduate School Of Medicine | Recruiting | Tsu | Mie-ken | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Recruiting | Takatsuki | Osaka | Japan |
| Saitama Medical University International Medical Center | Recruiting | Hidaka | Saitama | Japan |
| Niigata University Medical & Dental Hospital | Recruiting | Niigata | Japan |
| Okayama University Hospital | Recruiting | Okayama | Japan |
| The Cancer Institute Hospital of JFCR | Recruiting | Tokyo | Japan |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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