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NCT03765918 · ClinicalTrials.gov registry record · Phase 3
Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
A Phase 3 study of Head and Neck Neoplasms, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 714
- Enrollment target
- 20
- Study locations
NCT03765918: Active Phase 3 study of Head and Neck Neoplasms, sponsored by Merck Sharp & Dohme.
NCT03765918 is a Phase 3 study of Head and Neck Neoplasms that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 714 participants, above the 235-participant average among 23 other Head and Neck Neoplasms trials with a reported enrollment target (204% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03765918, a Phase 3 study of Head and Neck Neoplasms, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 714 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Primary Outcome
EFS was based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) and was defined as the time from randomization to any of the following events: radiographic disease progression (RDP; participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab 200 mg
- RADIATION Radiotherapy 60 Gray
- RADIATION Radiotherapy 66 Gray
- RADIATION Radiotherapy 70 Gray
- DRUG Cisplatin 100 mg/m^2
Study Locations (20)
California
- Moores Cancer Center ( Site 1885) - La Jolla
- University of Southern California Norris Comprehensive Cancer Center ( Site 1850) - Los Angeles
- Hoag Memoriall Hospital Presbyterian ( Site 2056) - Newport Beach
- UC Davis Health System ( Site 1864) - Sacramento
- St. Joseph Heritage Healthcare ( Site 1806) - Santa Rosa
Florida
- University of Florida ( Site 1832) - Gainesville
- University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008) - Miami
- AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 2054) - Orlando
- Orlando Health Cancer Institute ( Site 2061) - Orlando
Illinois
- Rush University Medical Center ( Site 1823) - Chicago
- NorthShore University HealthSystem ( Site 1812) - Evanston
- Loyola University Medical Center [Maywood, IL] ( Site 1817) - Maywood
District of Columbia
- MedStar Washington Hospital Center ( Site 2062) - Washington D.C.
- George Washington University Medical Faculty Associates ( Site 2035) - Washington D.C.
Idaho
- Saint Alphonsus Regional Medical Center ( Site 2021) - Boise
- Beacon Cancer Care ( Site 2052) - Post Falls
Colorado
- University of Colorado Cancer Center ( Site 1838) - Aurora
Kansas
- University of Kansas Cancer Center ( Site 2004) - Westwood
Kentucky
- University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069) - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 714 participants |
| Start Date | 2018-12-17 |
| Est. Completion | 2026-09-10 |
| Phase | Phase 3 |
What the registry record for NCT03765918 still lists
NCT03765918 is an interventional study that assigns participants to a tested intervention. The registered 714 participants enrollment target is mid-sized for trials with a published cap, above the 235-participant average among 23 other Head and Neck Neoplasms trials with a reported enrollment target (204% higher).
The record links to 1 condition, with Head and Neck Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab 200 mg is the first listed.
NCT03765918 names 20 study sites across 9 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03765918 about?
NCT03765918 is a clinical study titled "Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)". This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, ...
What is the current status of trial NCT03765918?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 714 participants. The study started on 2018-12-17. Estimated completion is 2026-09-10.
What conditions does trial NCT03765918 study?
This clinical trial studies the following conditions: Head and Neck Neoplasms.
What interventions are being tested in trial NCT03765918?
The interventions under investigation include: Pembrolizumab 200 mg (BIOLOGICAL), Radiotherapy 60 Gray (RADIATION), Radiotherapy 66 Gray (RADIATION), Radiotherapy 70 Gray (RADIATION), Cisplatin 100 mg/m^2 (DRUG).
Who is sponsoring clinical trial NCT03765918?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03765918 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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