drugset / Trial / NCT07860450
Two Part (Phase1b/ Phase3) Trial of Subcutaneous Dostarlimab Plus Carboplatin-Paclitaxel in Participants With Primary Advanced or Recurrent Endometrial Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dostarlimab | Monoclonal antibody | — | Subcutaneous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |