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Two Part (Phase1b/ Phase3) Trial of Subcutaneous Dostarlimab Plus Carboplatin-Paclitaxel in Participants With Primary Advanced or Recurrent Endometrial Cancer
Sponsor: GlaxoSmithKline
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
Conditions
Interventions
Dostarlimab
Dostarlimab will be administered as SC injection and IV infusion
Carboplatin and paclitaxel
Carboplatin and paclitaxel will be administered as an IV infusion