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NCT05173987 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Endometrial Neoplasms, sponsored by Merck Sharp & Dohme.

Active
Registry status
Phase 3
Development phase
280
Enrollment target
20
Study locations

NCT05173987 is a Phase 3 study of Endometrial Neoplasms that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 280 participants, below the 356-participant average among 14 other Endometrial Neoplasms trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT05173987, a Phase 3 study of Endometrial Neoplasms, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
280 participants
Enrollment target
20
Study locations

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 Studied

Endometrial Neoplasms

Interventions

  • BIOLOGICAL pembrolizumab
  • DRUG cisplatin
  • DRUG carboplatin
  • DRUG docetaxel
  • DRUG paclitaxel

Study Locations (20)

New York

  • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0023) - New York
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0016) - New York
  • Icahn School of Medicine at Mount Sinai ( Site 0052) - New York
  • Memorial Sloan Kettering Cancer Center ( Site 0009) - New York

California

  • Moores Cancer Center ( Site 0037) - La Jolla
  • Kaiser Permanente Riverside Medical Center ( Site 0045) - Riverside

Florida

  • Mount Sinai Cancer Center ( Site 0018) - Miami Beach
  • Sarasota Memorial Hospital ( Site 0005) - Sarasota

Georgia

  • Northside Hospital ( Site 0017) - Atlanta
  • Southeastern Regional Medical Center ( Site 0046) - Newnan

Arizona

  • HonorHealth-USOR HonorHealth ( Site 8000) - Phoenix

Connecticut

  • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0013) - New Haven

Illinois

  • Midwestern Regional Medical Center,Inc. DBA CTCA, Chicago ( Site 0003) - Zion

Indiana

  • St. Vincent Hospital and Health Care Center, Inc ( Site 0006) - Indianapolis

Trial Details

FieldValue
Enrollment Target 280 participants
Start Date 2022-02-03
Est. Completion 2027-05-27
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05173987

The ClinicalTrials.gov registry entry for NCT05173987 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 356-participant average among 14 other Endometrial Neoplasms trials with a reported enrollment target (21% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Endometrial Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which pembrolizumab is the first listed.

NCT05173987 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, California, Florida.

Frequently Asked Questions

What is clinical trial NCT05173987 about?

NCT05173987 is a clinical study titled "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)". 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 ...

What is the current status of trial NCT05173987?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2022-02-03. Estimated completion is 2027-05-27.

What conditions does trial NCT05173987 study?

This clinical trial studies the following conditions: Endometrial Neoplasms.

What interventions are being tested in trial NCT05173987?

The interventions under investigation include: pembrolizumab (BIOLOGICAL), cisplatin (DRUG), carboplatin (DRUG), docetaxel (DRUG), paclitaxel (DRUG).

Who is sponsoring clinical trial NCT05173987?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05173987 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.