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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-05-05

No results posted yet for this study

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).

Conditions

  • Endometrial Neoplasms

Interventions

BIOLOGICAL

pembrolizumab

Intravenous (IV) infusion

DRUG

carboplatin

IV infusion

DRUG

paclitaxel

IV infusion

DRUG

docetaxel

IV infusion

DRUG

cisplatin

IV infusion

Sponsors & Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • GOG Foundation

    collaborator NETWORK

  • Merck Sharp & Dohme LLC

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-03
Primary Completion
2027-05-27
Completion
2027-05-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05173987 on ClinicalTrials.gov