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NCT04634877 · ClinicalTrials.gov registry record · Phase 3
Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)
A Phase 3 study of Endometrial Neoplasms, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 990
- Enrollment target
- 20
- Study locations
NCT04634877: Active Phase 3 study of Endometrial Neoplasms, sponsored by Merck Sharp & Dohme.
NCT04634877 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 990 participants, above the 305-participant average among 14 other Endometrial Neoplasms trials with a reported enrollment target (225% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04634877, 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
- 990 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.
Primary Outcome
DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence, will be presented.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG Placebo for pembrolizumab
Study Locations (20)
New York
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076) - Mineola
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042) - New York
- Montefiore Medical Center ( Site 3065) - The Bronx
Alabama
- University of Alabama - Birmingham ( Site 3061) - Birmingham
- University of South Alabama, Mitchell Cancer Institute ( Site 3058) - Mobile
Arizona
- HonorHealth Research Institute - Biltmore ( Site 3043) - Phoenix
- Arizona Oncology Associates PC- HOPE ( Site 3049) - Tucson
Indiana
- Parkview Cancer Institute ( Site 3067) - Fort Wayne
- Indiana University Melvin and Bren Simon Cancer Center ( Site 3071) - Indianapolis
California
- UCSD Moores Cancer Center ( Site 3053) - La Jolla
Colorado
- University Of Colorado ( Site 3051) - Aurora
Connecticut
- Smilow Cancer Hospital at Yale New Haven ( Site 3070) - New Haven
Florida
- Mount Sinai Cancer Center ( Site 3081) - Miami Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 990 participants |
| Start Date | 2021-01-10 |
| Est. Completion | 2026-09-15 |
| Phase | Phase 3 |
What the registry record for NCT04634877 still lists
NCT04634877 is an interventional study that assigns participants to a tested intervention. The registered 990 participants enrollment target is mid-sized for trials with a published cap, above the 305-participant average among 14 other Endometrial Neoplasms trials with a reported enrollment target (225% higher).
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.
NCT04634877 names 20 study sites across 15 states, led by New York, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT04634877 about?
NCT04634877 is a clinical study titled "Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)". The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recur...
What is the current status of trial NCT04634877?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 990 participants. The study started on 2021-01-10. Estimated completion is 2026-09-15.
What conditions does trial NCT04634877 study?
This clinical trial studies the following conditions: Endometrial Neoplasms.
What interventions are being tested in trial NCT04634877?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Docetaxel (DRUG), Paclitaxel (DRUG), Placebo for pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT04634877?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04634877 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04634877's enrollment target sits among peer trials
990 1st of 14 higher than 14 of 14 other Endometrial Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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