drugset / Trial / NCT07860450

Two Part (Phase1b/ Phase3) Trial of Subcutaneous Dostarlimab Plus Carboplatin-Paclitaxel in Participants With Primary Advanced or Recurrent Endometrial Cancer

NCT07860450 ↗

Phase 1/2 Not yet recruiting 380 enrolled GlaxoSmithKline
RandomizedSequentialOpen-labelTreatment

Summary

This is an open-label study, meaning both the researchers and participants will know which treatment is being given. The study has two parts. In Part 1, researchers will identify the most suitable SC dose. In Part 2, participants will be randomly assigned by chance to receive dostarlimab as either an SC injection or an IV infusion. All participants will also receive carboplatin and paclitaxel. Treatment may continue for up to 3 years, with participants closely monitored throughout the study.

Timeline

Start
2026-11-12
Primary completion
2030-11-05
Completion
2032-11-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Dostarlimab Monoclonal antibody — Subcutaneous
Background Carboplatin Small molecule — Intravenous
Background Paclitaxel Small molecule — Intravenous

Indications