RecruitingPhase 3NCT07225270

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)


Sponsor

Genmab

Enrollment

528 participants

Start Date

Apr 3, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called rina-S (also known as rintodestrant, an oral estrogen receptor degrader) as maintenance therapy combined with standard of care in women with ovarian, fallopian tube, or primary peritoneal cancer that has come back after initial treatment and is still sensitive to platinum-based chemotherapy. **You may be eligible if...** - You have high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer confirmed by biopsy - Your cancer came back more than 6 months after completing your first round of platinum-based chemotherapy - You have completed second-line platinum-based chemotherapy and your cancer either went away, partially shrank, or remained stable - You are being randomized within 8 weeks of your last dose of second-line chemotherapy - If your cancer has a BRCA mutation or HRD-positive status and you completed first-line treatment with a complete or partial response, you must have already received PARP inhibitor maintenance after first-line treatment **You may NOT be eligible if...** - Your cancer came back within 6 months of completing first-line platinum chemotherapy (platinum-resistant) - You have not completed the required prior treatment steps - You have significant liver, kidney, heart, or blood count abnormalities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRina-S

Intravenous (IV) infusion

DRUGBevacizumab

IV infusion


Locations(9)

Mt. Sinai Comprehensive Cancer Center

Miami, Florida, United States

Miami Valley Hospital South

Centerville, Ohio, United States

National Hospital Organization Hokkaido Cancer Center

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

Niigata University Medical & Dental Hospital

Niigata, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT07225270


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