Active Not Recruiting
PHASE3
INTERVENTIONAL
NCT05201547
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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
Interventions
Name:
Carboplatin-Paclitaxel
Type:
DRUG
Description:
Chemotherapy will be administered by intravenous infusion. Carboplatin AUC 5-6 + Pacltaxel 175 mg/m² every 3 weeks. Total duration of treatment: 6 cycles
Name:
Dostarlimab
Type:
DRUG
Description:
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.
Primary Outcomes
Measure:
Progression Free Survival (PFS)
TimeFrame:
from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 5 years.
Description:
Defined as the time from the date of randomization until objective tumor progression based on RECIST 1.1, by BICR (Blinded Independent Central Review), or death due to any cause, whichever occurs first. Patients alive and free of progression will be censored at the last disease assessment date.
Trial Information
NCT ID
NCT05201547
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
ARCAGY/ GINECO GROUP
Last Updated
December 15, 2025