NCT07225270

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

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L Platinum-Based Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 528 (estimated)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Ovarian Cancer
• Platinum-sensitive Ovarian Cancer
• PSOC

Interventions

Type	Name	Description
DRUG	Rina-S	Intravenous (IV) infusion
DRUG	Bevacizumab	IV infusion

Timeline

• Start date: 2026-04-03
• Primary completion: 2028-10-01
• Completion: 2030-04-01
• First posted: 2025-11-06
• Last updated: 2026-04-08

Locations

9 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study