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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
MinorTrial sites expanded: 22 → 34 locationsEligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 2 of 6 entriesShow 2 more changesShow less
Eligibility criteria expanded, about 10 words
Secondary endpoints: details revised at 2 of 6 entries
MinorTrial sites expanded: 16 → 22 locationsv17
MinorRe-verified, no change to tracked fieldsv16
NotablePrimary endpoint(s) modifiedTrial sites expanded: 13 → 16 locations · Completion pushed from Apr 2030 to May 2030 · Enrollment target: 528 to 544 · 1 morev15Show 4 more changesShow less
MinorTrial sites expanded: 2 → 8 locationsStart date changed from estimate of Apr 15, 2026 to Apr 3, 2026v12Show 1 more changeShow less
Start date changed from estimate of Apr 15, 2026 to Apr 3, 2026
NotableStart date: Mar 16, 2026 to Apr 15, 2026Study sites: 2 to 8 · Secondary endpoints revised (6) · Eligibility criteria shortened, about 5 words · 1 morev11Show 4 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.