๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-03

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)

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Genmab

๐Ÿฉบ 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 โ€” Miami, Florida

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Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (16 Sites)

  • Mt. Sinai Comprehensive Cancer Center โ€” Miami, Florida
  • Sarasota Memorial Health Care System โ€” Sarasota, Florida
  • Miami Valley Hospital South โ€” Centerville, Ohio
  • Zangmeister Cancer Center โ€” Columbus, Ohio
  • National Hospital Organization Hokkaido Cancer Center โ€” Sapporo, Hokkaido
  • Sapporo Medical University Hospital โ€” Sapporo, Hokkaido
  • Hyogo Cancer Center โ€” Akashi, Hyลgo
  • Mie University Graduate School Of Medicine โ€” Tsu, Mie-ken
  • Osaka Medical and Pharmaceutical University Hospital โ€” Takatsuki, Osaka
  • Saitama Medical University International Medical Center โ€” Hidaka, Saitama
  • The Jikei University Kashiwa Hospital โ€” Kashiwa,
  • Niigata University Medical & Dental Hospital โ€” Niigata,
  • Okayama University Hospital โ€” Okayama,
  • Kitasato University Hospital โ€” Sagamihara,
  • The Cancer Institute Hospital of JFCR โ€” Tokyo,
  • Kanagawa Prefectural Cancer Center โ€” Yokohama,

๐Ÿ’ฐ 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 ยง 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.
๐Ÿ›๏ธ View Official NIH Record โ†—