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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
Sponsor: Genmab
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.
Official title: 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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
544
Start Date
2026-04-03
Completion Date
2030-05
Last Updated
2026-10-06
Healthy Volunteers
No
Interventions
Rina-S
Intravenous (IV) infusion
Bevacizumab
IV infusion
Locations (34)
Mt. Sinai Comprehensive Cancer Center
Miami, Florida, United States
Sarasota Memorial Health Care System
Sarasota, Florida, United States
Greater Baltimore Medical Center
Towson, Maryland, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Zangmeister Cancer Center
Columbus, Ohio, United States
Alliance Cancer Specialists - Abington Hematology Oncology Associates - Horsham
Horsham, Pennsylvania, United States
UZ Leuven - Gasthuisberg Campus
Leuven, Belgium
AZ Delta - Uw Ziekenhuis
Roeselare, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
Kuopion Yliopistollinen Sairaala
Kuopio, Finland
Hôpital Privé du Confluent
Nantes, France
Hôpital René Huguenin
Saint-Cloud, France
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Mie University Graduate School Of Medicine
Tsu, Mie-ken, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
The Jikei University Kashiwa Hospital
Kashiwa, Japan
St Marianna University School of Medicine
Kawasaki, Japan
Kurume University Hospital
Kurume, Japan
Shizuoka Cancer Center
Nagaizumi-chō, Japan
Niigata University Medical & Dental Hospital
Niigata, Japan
Okayama University Hospital
Okayama, Japan
Kitasato University Hospital
Sagamihara, Japan
Tohoku University Hospital
Sendai, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Kanagawa Prefectural Cancer Center
Yokohama, Japan
Haukeland University Hospital
Bergen, Norway
Białostockie Centrum Onkologii im. M. Skłodowskiej-Curie w Białymstoku
Bialystok, Poland
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain