A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

• Status: Recruiting
• Trial end date: 2026-11-30

Summary

This is a 2 part study. Part 1 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo; and Part 2 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo in participants with recurrent or primary advanced (Stage III or IV) endometrial cancer. Part 1 has completed enrollment, and Part 2 is open for enrollment. Both Parts consist of a Screening Period, Treatment Period, an End of Treatment (EOT) Visit, a Safety Follow-up Visit, and a Survival Assessment Period. In Part 2, participants will be randomized 1:2 to receive either carboplatin/paclitaxel/placebo or Dostarlimab/carboplatin/paclitaxel followed by Dostarlimab/niraparib or placebo iv/oral maintenance.

• Phase: Phase 3

Details

• Lead Sponsor: Tesaro, Inc.
• Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT); GOG Foundation; Gynecologic Oncology Group
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Niraparib; Paclitaxel