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A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy
The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected. All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).
This is a global, open-label, randomized Phase 3 study in approximately 544 participants with recurrent or progressive EC following prior therapy. Participants will be randomized in a 1:1 ratio to receive treatment with Rina-S vs investigator's choice (IC) (paclitaxel or doxorubicin). Investigators must select one of the IC treatment options for each participant prior to randomization so that this may be used for treatment assignment if the participant is randomized to the IC arm.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
SMH - Sarasota - Main Campus
Sarasota, Florida, United States
Emory Winship Cancer Inst.
Atlanta, Georgia, United States
Emory Winship Cancer Inst.
Atlanta, Georgia, United States
Emory Winship Cancer Inst./Emory Decatur Hospital
Decatur, Georgia, United States
Trials365, LLC
Shreveport, Louisiana, United States
Sinai Hospital
Baltimore, Maryland, United States
William Kahlert Reg. Can. Ctr
Westminster, Maryland, United States
USOR - Minnesota Oncology/ Coon Rapids Clinic
Coon Rapids, Minnesota, United States
USOR - Minnesota Oncology/Edina Clinic
Edina, Minnesota, United States
USOR - Minnesota Oncology/ Maple Grove Clinic
Maple Grove, Minnesota, United States
Start Date
November 28, 2025
Primary Completion Date
November 1, 2028
Completion Date
February 1, 2029
Last Updated
March 3, 2026
544
ESTIMATED participants
Rina-S
DRUG
IC
DRUG
Lead Sponsor
Genmab
NCT05489211
NCT04657068
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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