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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: Active Phase 3 study of Endometrial Neoplasms, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
PFS is defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2022-02-03 |
| Est. Completion | 2027-05-27 |
| Phase | Phase 3 |
What the registry record for NCT05173987 still lists
NCT05173987 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 356-participant average among 14 other Endometrial Neoplasms trials with a reported enrollment target (21% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
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Where NCT05173987's enrollment target sits among peer trials
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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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