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 (NCT07225270)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mt. Sinai Comprehensive Cancer Center — Miami, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- Mt. Sinai Comprehensive Cancer Center — Miami, Florida
- Sarasota Memorial Health Care System — Sarasota, Florida
- Miami Valley Hospital South — Centerville, Ohio
- Zangmeister Cancer Center — Columbus, Ohio
- National Hospital Organization Hokkaido Cancer Center — Sapporo, Hokkaido
- Sapporo Medical University Hospital — Sapporo, Hokkaido
- Hyogo Cancer Center — Akashi, Hyōgo
- Mie University Graduate School Of Medicine — Tsu, Mie-ken
- Osaka Medical and Pharmaceutical University Hospital — Takatsuki, Osaka
- Saitama Medical University International Medical Center — Hidaka, Saitama
- The Jikei University Kashiwa Hospital — Kashiwa,
- Niigata University Medical & Dental Hospital — Niigata,
- Okayama University Hospital — Okayama,
- Kitasato University Hospital — Sagamihara,
- The Cancer Institute Hospital of JFCR — Tokyo,
- Kanagawa Prefectural Cancer Center — Yokohama,
📞 Contact the Study Coordinator
Phone: (457) 020-2728
Email: clinicaltrials@genmab.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: 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).
More studies in Ovarian Cancer
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- Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer — Pittsburgh, Pennsylvania
- Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer — Houston, Texas
- Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors — Duarte, California
- Trial on Radical Upfront Surgery in Advanced Ovarian Cancer — New York, New York
Explore by condition: All Ovarian Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.