Clinical Trial

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

Study acronym: RAINFOL-03
Recruiting Phase 3
View on ClinicalTrials.gov →
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).
Protocol Amendment History 8 changes
notable Trial sites expanded: 120 -> 147 locations 2026-08-05
notable Trial sites expanded: 81 -> 120 locations 2026-07-08
notable Trial sites expanded: 74 -> 81 locations 2026-06-03
critical Primary endpoint(s) modified 2026-05-07
notable Enrollment increased: 544 -> 660 participants 2026-05-07
notable Trial sites expanded: 51 -> 74 locations 2026-05-07
notable Primary completion pushed: 2028-11 -> 2029-08 2026-05-07
minor Completion pushed: 2029-02 -> 2029-11 2026-05-07
Trial Details
NCT Number NCT07166094
Lead Sponsor Genmab
Conditions Endometrial Cancer, Recurrent or Progressive Endometrial Cancer
Enrollment 660 participants
Start Date 2025-11-28
Primary Completion 2029-08 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-04