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
Start Date
4/3/2026
Completion Date
5/1/2030
Summary
This Phase 3 study will be conducted in different countries around the world with up to about 544 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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Rina-S
Bevacizumab
Conditions
Locations
Mt. Sinai Comprehensive Cancer Center
Miami, Florida 33140
United States
Sarasota Memorial Health Care System
Sarasota, Florida 34239
United States
Miami Valley Hospital South
Centerville, Ohio 45459
United States
Zangmeister Cancer Center
Columbus, Ohio 43219
United States
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido
Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido
Japan
Hyogo Cancer Center
Akashi, Hyōgo
Japan
Mie University Graduate School Of Medicine
Tsu, Mie-ken
Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka
Japan
Saitama Medical University International Medical Center
Hidaka, Saitama
Japan
The Jikei University Kashiwa Hospital
Kashiwa,
Japan
Niigata University Medical & Dental Hospital
Niigata,
Japan
Okayama University Hospital
Okayama,
Japan
Kitasato University Hospital
Sagamihara,
Japan
The Cancer Institute Hospital of JFCR
Tokyo,
Japan
Kanagawa Prefectural Cancer Center
Yokohama,
Japan