Clinical Trial

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

Study acronym: RAINFOL-04
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-07-17
notable Trial sites expanded: 13 -> 16 locations 2026-07-17
minor Completion pushed: 2030-04 -> 2030-05 2026-07-17
notable Trial sites expanded: 10 -> 13 locations 2026-06-03
notable Trial sites expanded: 2 -> 8 locations 2026-04-08
Trial Details
NCT Number NCT07225270
Lead Sponsor Genmab
Conditions Ovarian Cancer, Platinum-sensitive Ovarian Cancer, PSOC
Enrollment 544 participants
Start Date 2026-04-03
Primary Completion 2028-10 (estimated)
Study Completion 2030-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-04