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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab 200 mg: 200 mg administered IV infusion on Day 1 of each 21-day cycle
Radiotherapy 60 Gray: Low risk participants administered 2 Gray in 30 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 66 Gray: High risk participants administered 2 Gray in 33 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 70 Gray: Participants with gross residual disease administered 2 Gray in 35 fractions. Administered using intensity modulated radiation therapy.
Cisplatin 100 mg/m^2: 100 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle
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.
Eligibility
Primary outcome measure(s)
- Event-free Survival (EFS) — Up to ~66 months
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 distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in all randomized participants was presented. - EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 — Up to ~66 months
EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: 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 distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥10 was presented. - EFS in Participants With PD-L1 CPS ≥1 — Up to ~66 months
EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: 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 distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥1 was presented.
Trial sites (192)
| Facility | City | Region | Status |
|---|---|---|---|
| Moores Cancer Center ( Site 1885) | La Jolla | California | |
| University of Southern California Norris Comprehensive Cancer Center ( Site 1850) | Los Angeles | California | |
| Hoag Memoriall Hospital Presbyterian ( Site 2056) | Newport Beach | California | |
| UC Davis Health System ( Site 1864) | Sacramento | California | |
| St. Joseph Heritage Healthcare ( Site 1806) | Santa Rosa | California | |
| University of Colorado Cancer Center ( Site 1838) | Aurora | Colorado | |
| MedStar Washington Hospital Center ( Site 2062) | Washington D.C. | District of Columbia | |
| George Washington University Medical Faculty Associates ( Site 2035) | Washington D.C. | District of Columbia | |
| University of Florida ( Site 1832) | Gainesville | Florida | |
| University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008) | Miami | Florida | |
| AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 2054) | Orlando | Florida | |
| Orlando Health Cancer Institute ( Site 2061) | Orlando | Florida | |
| Saint Alphonsus Regional Medical Center ( Site 2021) | Boise | Idaho | |
| Beacon Cancer Care ( Site 2052) | Post Falls | Idaho | |
| Rush University Medical Center ( Site 1823) | Chicago | Illinois | |
| NorthShore University HealthSystem ( Site 1812) | Evanston | Illinois | |
| Loyola University Medical Center [Maywood, IL] ( Site 1817) | Maywood | Illinois | |
| University of Kansas Cancer Center ( Site 2004) | Westwood | Kansas | |
| University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069) | Lexington | Kentucky | |
| Ochsner Cancer Institute ( Site 2045) | New Orleans | Louisiana | |
| University of Maryland ( Site 2031) | Baltimore | Maryland | |
| Dana Farber Cancer Center ( Site 1873) | Boston | Massachusetts | |
| University of Massachusetts Memorial Medical Center ( Site 1875) | Worcester | Massachusetts | |
| Karmanos Cancer Institute ( Site 1870) | Detroit | Michigan | |
| Henry Ford Health System ( Site 1803) | Detroit | Michigan | |
| Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016) | Edina | Minnesota | |
| University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058) | Columbia | Missouri | |
| Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897) | Springfield | Missouri | |
| Washington University School of Medicine ( Site 1800) | St Louis | Missouri | |
| St. Vincent Healthcare Frontier Cancer Center ( Site 1818) | Billings | Montana | |
| Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036) | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039) | Middletown | New Jersey | |
| MSKCC-Bergen ( Site 2037) | Montvale | New Jersey | |
| Rutgers Cancer Institute of New Jersey ( Site 2071) | New Brunswick | New Jersey | |
| Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053) | Newark | New Jersey | |
| The University of New Mexico Comprehensive Cancer Center ( Site 1882) | Albuquerque | New Mexico | |
| Erie County Medical Center ( Site 2047) | Buffalo | New York | |
| Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038) | Commack | New York | |
| Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041) | Harrison | New York | |
| Monter Cancer Center ( Site 2060) | Lake Success | New York |
+ 152 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in Poland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03765918 on ClinicalTrials.gov ↗ ← All trials in Poland