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NCT03833167 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
A Phase 3 study of Carcinoma, Squamous Cell, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT03833167 is a Phase 3 study of Carcinoma, Squamous Cell that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 450 participants, above the 228-participant average among 14 other Carcinoma, Squamous Cell trials with a reported enrollment target (97% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT03833167, a Phase 3 study of Carcinoma, Squamous Cell, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
Study Locations (20)
California
- City of Hope Medical Center ( Site 1505) - Duarte
- UCSD Moores Cancer Center ( Site 1561) - La Jolla
- UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568) - Los Angeles
- University of California Davis Comprehensive Cancer Center ( Site 1560) - Sacramento
- Stanford University Medical Center ( Site 1503) - Stanford
Florida
- Boca Raton Regional Hospital ( Site 1551) - Boca Raton
- UF Health ( Site 1511) - Gainesville
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544) - Miami
Massachusetts
- Massachusetts General Hospital ( Site 1518) - Boston
- Dana Farber Cancer Center ( Site 1519) - Boston
New York
- Northwell Health/ RJ Zuckerberg Cancer Center-Medical Oncology ( Site 1565) - Lake Success
- Icahn School of Medicine at Mount Sinai ( Site 1575) - New York
Alabama
- University of South Alabama, Mitchell Cancer Institute ( Site 1562) - Mobile
Colorado
- University of Colorado Cancer Center ( Site 1506) - Aurora
Connecticut
- Smilow Cancer Center at Yale-New Haven ( Site 1507) - New Haven
Georgia
- Winship Cancer Institute of Emory University ( Site 1512) - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2026-01-20 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03833167
The ClinicalTrials.gov registry entry for NCT03833167 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 228-participant average among 14 other Carcinoma, Squamous Cell trials with a reported enrollment target (97% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Carcinoma, Squamous Cell appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03833167 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03833167 about?
NCT03833167 is a clinical study titled "Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)". This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The pr...
What is the current status of trial NCT03833167?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2019-04-01. Estimated completion is 2026-01-20.
What conditions does trial NCT03833167 study?
This clinical trial studies the following conditions: Carcinoma, Squamous Cell.
What interventions are being tested in trial NCT03833167?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG).
Who is sponsoring clinical trial NCT03833167?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03833167 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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