Actively Recruiting
Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy
Led by Genmab · Updated on 2026-05-05
528
Participants Needed
10
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Must have platinum-sensitive ovarian cancer defined as disease progression more than 6 months after last first-line platinum therapy.
- Participants with known BRCA mutation or homologous recombination deficiency positive ovarian cancer who achieved complete or partial response following first-line platinum chemotherapy must have previously received PARP inhibitor maintenance therapy.
- Must have completed second-line platinum-based chemotherapy for recurrent platinum-sensitive ovarian cancer.
- Must be randomized no later than 8 weeks from the last dose of second-line platinum-based therapy.
- Must have achieved complete response, no evidence of disease, partial response, or stable disease if bevacizumab was given with second-line platinum chemotherapy, as assessed by investigator.
You will not qualify if you...
- Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these, or low-grade/borderline ovarian tumors.
- More than two prior lines of systemic therapy.
- Disease progression while on or following second-line platinum-based chemotherapy before randomization.
- Receipt of any systemic anticancer treatment other than bevacizumab after second-line platinum chemotherapy and before randomization.
- Other protocol-defined exclusion criteria may apply.
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Trial Site Locations
Total: 10 locations
1
Mt. Sinai Comprehensive Cancer Center
Miami, Florida, United States, 33140
Actively Recruiting
2
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Actively Recruiting
3
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Actively Recruiting
4
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Actively Recruiting
5
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Actively Recruiting
6
Mie University Graduate School Of Medicine
Tsu, Mie-ken, Japan
Actively Recruiting
7
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
Actively Recruiting
8
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Actively Recruiting
9
Niigata University Medical & Dental Hospital
Niigata, Japan
Actively Recruiting
10
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Actively Recruiting
Research Team
G
Genmab Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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