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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524202-15 | Other Identifier | EU CT No. | |
| GOG-3143 | Other Identifier | Other Identifier | |
| ENGOT-ov103 | Other Identifier | Other Identifier | |
| GEICO-177-O | Other Identifier | Other Identifier | |
| APGOT-ov21 | Other Identifier | Other Identifier | |
| LACOG 0126-EVA | Other Identifier | Other Identifier |
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This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.
The 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.
Participants will receive either:
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 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.
The 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Rina-S ± Bevacizumab | Experimental | Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W). |
|
| Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab | Active Comparator | Participants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rina-S | Biological | Intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to approximately 5 years | |
| PFS per RECIST v1.1, as Determined by Investigator | Up to approximately 3 years | |
| Objective Response Rate (ORR) per RECIST v1.1 |
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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 |
|---|---|---|---|---|---|---|
| Danbury Hospital | Danbury | Connecticut | 06810 | United States | ||
| ProHealth Care Inc |
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| Bevacizumab | Drug | IV infusion |
|
| Carboplatin | Drug | IV infusion |
|
| Gemcitabine | Drug | IV infusion |
|
| Paclitaxel | Drug | IV infusion |
|
| PLD | Drug | IV infusion |
|
| Up to approximately 3 years |
| Duration of Response (DOR) per RECIST v1.1 | Up to approximately 3 years |
| Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2) | Up to approximately 3 years |
| Time to First Subsequent Therapy (TFST) | Up to approximately 3 years |
| Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria | Up to approximately 3 years |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to approximately 3 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 Quality of Life Questionnaire Core 30 (EORTC QLQ C30) | Baseline up to approximately 3 years |
| Time to Deterioration (TTD) in the GHS/QoL Score Using the EORTC QLQ C30 Questionnaire | Up to approximately 3 years |
| Waukesha |
| Wisconsin |
| 53188 |
| United States |
| 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 |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| C041277 | 1-dodecylpyridoxal |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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