drugset / Trial / NCT05173987

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

NCT05173987 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).

Timeline

Start
2022-02-03
Primary completion
2027-05-27
Completion
2027-05-27

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 5 unknown Intravenous
Comparator Carboplatin Small molecule 6 unknown Intravenous
Comparator Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous

Indications