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NOT YET RECRUITING
NCT07860450
PHASE1/PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: An Open-label, Multicenter, 2-Part Study: A Phase 1b Dose Selection Followed by a Randomized Phase 3 to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Dostarlimab Plus Carboplatin-Paclitaxel Versus Intravenous Dostarlimab Plus Carboplatin-Paclitaxel in Participants With Primary Advanced or Recurrent Endometrial Cancer (SAPPHIRE)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2026-11-12

Completion Date

2032-11-05

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

Dostarlimab

Dostarlimab will be administered as SC injection and IV infusion

DRUG

Carboplatin and paclitaxel

Carboplatin and paclitaxel will be administered as an IV infusion