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)
Public ClinicalTrials.gov record NCT03765918. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03765918
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 714 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab 200 mg Biological
- Radiotherapy 60 Gray Radiation
- Radiotherapy 66 Gray Radiation
- Radiotherapy 70 Gray Radiation
- Cisplatin 100 mg/m^2 Drug
Biological · Radiation · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 17, 2018 (Actual)
- Primary completion
- Jul 25, 2024 (Actual)
- Completion
- Nov 17, 2026 (Estimated)
- Last update posted
- Jul 31, 2026
2018 – 2026
United States locations
- U.S. sites
- 68
- U.S. states
- 30
- U.S. cities
- 59
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Moores Cancer Center ( Site 1885) | La Jolla | California | 92093-0698 | — |
| University of Southern California Norris Comprehensive Cancer Center ( Site 1850) | Los Angeles | California | 90033 | — |
| Hoag Memoriall Hospital Presbyterian ( Site 2056) | Newport Beach | California | 92663 | — |
| UC Davis Health System ( Site 1864) | Sacramento | California | 95817 | — |
| St. Joseph Heritage Healthcare ( Site 1806) | Santa Rosa | California | 95403 | — |
| University of Colorado Cancer Center ( Site 1838) | Aurora | Colorado | 80045 | — |
| MedStar Washington Hospital Center ( Site 2062) | Washington D.C. | District of Columbia | 20010 | — |
| George Washington University Medical Faculty Associates ( Site 2035) | Washington D.C. | District of Columbia | 20037 | — |
| University of Florida ( Site 1832) | Gainesville | Florida | 32608 | — |
| University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008) | Miami | Florida | 33136 | — |
| AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 2054) | Orlando | Florida | 32804 | — |
| Orlando Health Cancer Institute ( Site 2061) | Orlando | Florida | 32806 | — |
| Saint Alphonsus Regional Medical Center ( Site 2021) | Boise | Idaho | 83706 | — |
| Beacon Cancer Care ( Site 2052) | Post Falls | Idaho | 83854 | — |
| Rush University Medical Center ( Site 1823) | Chicago | Illinois | 60607 | — |
| NorthShore University HealthSystem ( Site 1812) | Evanston | Illinois | 60201 | — |
| Loyola University Medical Center [Maywood, IL] ( Site 1817) | Maywood | Illinois | 60153 | — |
| University of Kansas Cancer Center ( Site 2004) | Westwood | Kansas | 66205 | — |
| University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069) | Lexington | Kentucky | 40536 | — |
| Ochsner Cancer Institute ( Site 2045) | New Orleans | Louisiana | 70121 | — |
| University of Maryland ( Site 2031) | Baltimore | Maryland | 21201 | — |
| Dana Farber Cancer Center ( Site 1873) | Boston | Massachusetts | 02215 | — |
| University of Massachusetts Memorial Medical Center ( Site 1875) | Worcester | Massachusetts | 01655 | — |
| Karmanos Cancer Institute ( Site 1870) | Detroit | Michigan | 48201 | — |
| Henry Ford Health System ( Site 1803) | Detroit | Michigan | 48202 | — |
| Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016) | Edina | Minnesota | 55435 | — |
| University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058) | Columbia | Missouri | 65212 | — |
| Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897) | Springfield | Missouri | 65804 | — |
| Washington University School of Medicine ( Site 1800) | St Louis | Missouri | 63110 | — |
| St. Vincent Healthcare Frontier Cancer Center ( Site 1818) | Billings | Montana | 59102 | — |
| Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036) | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039) | Middletown | New Jersey | 07748 | — |
| MSKCC-Bergen ( Site 2037) | Montvale | New Jersey | 07645 | — |
| Rutgers Cancer Institute of New Jersey ( Site 2071) | New Brunswick | New Jersey | 08903 | — |
| Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053) | Newark | New Jersey | 07103 | — |
| The University of New Mexico Comprehensive Cancer Center ( Site 1882) | Albuquerque | New Mexico | 87131-0001 | — |
| Erie County Medical Center ( Site 2047) | Buffalo | New York | 14215 | — |
| Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038) | Commack | New York | 11725 | — |
| Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041) | Harrison | New York | 10604 | — |
| Monter Cancer Center ( Site 2060) | Lake Success | New York | 11042 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014) | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center ( Site 1857) | New York | New York | 10021 | — |
| Weill Cornell Medical College ( Site 2050) | New York | New York | 10065 | — |
| Northwell Health Cancer Institute ( Site 2030) | New York | New York | 10075 | — |
| Stony Brook University ( Site 2063) | Stony Brook | New York | 11794 | — |
| Montefiore Einstein Center ( Site 2028) | The Bronx | New York | 10467 | — |
| Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040) | Uniondale | New York | 11553 | — |
| Levine Cancer Institute ( Site 2003) | Charlotte | North Carolina | 28204 | — |
| Wake Forest Compenhensive Cancer Center ( Site 2029) | Winston-Salem | North Carolina | 27357 | — |
| Sanford Health Roger Maris Cancer Center ( Site 2034) | Fargo | North Dakota | 58122 | — |
| University Hospitals ( Site 2032) | Cleveland | Ohio | 44106 | — |
| The Ohio State University ( Site 2012) | Columbus | Ohio | 43210 | — |
| Providence Portland Medical Center ( Site 1843) | Portland | Oregon | 97220 | — |
| Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022) | Portland | Oregon | 97227 | — |
| Oregon Health Science University ( Site 1871) | Portland | Oregon | 97239 | — |
| St. Luke's University Health Network ( Site 1801) | Bethlehem | Pennsylvania | 18015 | — |
| Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059) | Philadelphia | Pennsylvania | 19107 | — |
| Allegheny General Hospital ( Site 1833) | Pittsburgh | Pennsylvania | 15212 | — |
| Sanford Cancer Center Oncology Clinic ( Site 1859) | Sioux Falls | South Dakota | 57104 | — |
| Avera Cancer Institute- Research ( Site 2070) | Sioux Falls | South Dakota | 57105 | — |
| Henry Joyce Cancer Clinic ( Site 1827) | Nashville | Tennessee | 37232 | — |
| UT Southwestern Medical Center ( Site 1841) | Dallas | Texas | 75390 | — |
| USA Clinical Trials ( Site 2068) | San Antonio | Texas | 78229 | — |
| University of Utah, Huntsman Cancer Institute ( Site 1855) | Salt Lake City | Utah | 84112-5550 | — |
| University of Vermont Medical Center ( Site 2009) | Burlington | Vermont | 05401 | — |
| UVA Health System - Emily Couric Cancer Center ( Site 1826) | Charlottesville | Virginia | 22908 | — |
| Inova Schar Cancer Institute ( Site 2026) | Fairfax | Virginia | 22031 | — |
| Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865) | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 124 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03765918, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03765918 live on ClinicalTrials.gov.