Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care Maintenance Treatment After First-line (1L) Platinum-based Chemotherapy in Participants With Ovarian Cancer

Summary

This Phase 3 study will be conducted in different countries around the world with up to approximately 602 participants. The purpose of this study is to evaluate how well Rina-S alone or in combination with an approved, standard of care (SOC) treatment works against ovarian cancer (including primary peritoneal or fallopian tube cancer) compared to the same available SOC therapy by itself, or no treatment (only monitoring). On average, the expected trial duration for an individual participant will be approximately 4 years (depending on treatment received). The treatment length and follow-up duration will be different for every participant, but an average of 16 months of treatment is expected, followed by an estimated 29-month post treatment follow up period. Participation in the study will require visits to the study site(s). Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 weeks). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the trial treatment is safe and effective. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep receiving trial treatment for the protocol-defined study duration.

Timeline

Start

2026-11

Primary completion

2030-03

Completion

2034-07

Drugs

Indications