Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer

Active:	Yes
Cancer Type:	Uterine Cancer	NCT ID:	NCT07166094
Trial Phases:	Phase III	Protocol IDs:	GCT1184-03 (primary) NCI-2025-08516 2024-519818-31 ENGOT-en31 GEICO-158-E GOG-3128 jRCT2031250494 MOH_2026-03-29_015739
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Genmab
NCI Full Details:	http://clinicaltrials.gov/show/NCT07166094

Summary

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).

Objectives

This is a global, open-label, randomized Phase 3 study in approximately 660 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.

Treatment Sites in Georgia

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.