Phase 3 Study Comparing Rina-S to Doctors Choice Chemotherapy for Recurrent or Progressive Endometrial Cancer After Prior Treatment

What this Trial Is About

Researchers are evaluating the effectiveness of Rina-S GEN1184 compared to standard chemotherapy treatments chosen by physicians for women with recurrent or progressive endometrial cancer after prior therapy. This global, open-label, randomized Phase 3 trial includes about 660 female participants and aims to better understand treatment outcomes following previous platinum-based chemotherapy and PDL-1 inhibitor therapy. Participants will be randomly assigned to receive either Rina-S every three weeks by intravenous infusion or an investigators choice of chemotherapy paclitaxel given weekly for three weeks every four weeks or doxorubicin given once every three weeks. The treatment duration varies but is expected to last on average four to six months, with the total study duration approximately three years. No placebo is used all participants receive active treatment. During the study, participants will visit the study sites regularly for treatment and monitoring. Researchers will assess progression-free survival and overall survival up to about three years. Additional evaluations include tumor response rates, duration of response, treatment-emergent side effects, and quality of life measures. Safety and health status will be carefully monitored throughout participation.

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