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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)
NCT03765918 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03765918
The ClinicalTrials.gov registry entry for NCT03765918 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 714 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03765918 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03765918?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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