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)
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.
* Is eligible for primary surgery based on investigator decision and per local practice
* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy.
* Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy
* Female participant that is not pregnant or breastfeeding
* Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
* Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Has results from testing of HPV status for oropharyngeal cancer defined as p16
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization
Exclusion Criteria:
* Has Stage T4B and/or N3 locoregionally advanced head and neck squamous cell carcinoma (LA HNSCC) and/or distant metastases
* Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity. such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer (HNC)
* Female participant who has a positive urine pregnancy test within 72 hours prior to study start or within 24 hours prior to the start of radiotherapy with or without cisplatin.
* Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1(PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor
* Has received prior radiotherapy treatment or systemic anti-cancer therapy including investigational agents for the HNC under study prior to study start
* Has received a live vaccine within 30 days prior to randomization
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy
* Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis
* Has Grade ≥2 audiometric hearing loss
* Has Grade ≥2 neuropathy
* Has Grade 3-4 bleeding due to the underlying malignancy
* Has received major surgery or has not recovered adequately from the toxicity and/or complications from the intervention prior to study start
* Has had previous allogeneic tissue/solid organ transplant
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, radiotherapy, cisplatin or their analogs
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of or is positive for Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C (defined as Hepatitis C virus \[HCV\] ribonucleic acid is detected).
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the investigator
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
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.
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.
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