NCT05201547

Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line

Randomized Phase III Trial in MMR Deficient Endometrial Cancer Patients Comparing Chemotherapy Alone Versus Dostarlimab in First Line Advanced/Metastatic Setting

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer.

Detailed description

Phase III, randomized, open label, multi-centre study. Randomization on a 1:1 ratio, stratification performed according to: * Prior adjuvant chemotherapy (yes or no) * Prior pelvic radiotherapy (yes or no) * Disease status: newly diagnosed advanced / metastatic disease versus relapse

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin-Paclitaxel	Chemotherapy will be administered by intravenous infusion. Carboplatin AUC 5-6 + Pacltaxel 175 mg/m² every 3 weeks. Total duration of treatment: 6 cycles
DRUG	Dostarlimab	Dostarlimab will be administered through a 30-minute infusion at a dose of 500 mg Q3W from Cycle 1 through Cycle 4 and at a dose of 1,000 mg Q6W thereafter, beginning at Cycle 5 Day 1 up to a maximum of 2 years.

Timeline

• Start date: 2022-04-15
• Primary completion: 2026-04-01
• Completion: 2029-10-01
• First posted: 2022-01-21
• Last updated: 2025-12-04

Locations

100 sites across 10 countries: Australia, Canada, France, Italy, Japan, New Zealand, Singapore, South Korea, Spain, United Kingdom