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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)
Sponsor: Merck Sharp & Dohme LLC
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
714
Start Date
2018-12-17
Completion Date
2026-09-10
Last Updated
2025-08-20
Healthy Volunteers
No
Conditions
Interventions
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
Locations (192)
Moores Cancer Center ( Site 1885)
La Jolla, California, United States
University of Southern California Norris Comprehensive Cancer Center ( Site 1850)
Los Angeles, California, United States
Hoag Memoriall Hospital Presbyterian ( Site 2056)
Newport Beach, California, United States
UC Davis Health System ( Site 1864)
Sacramento, California, United States
St. Joseph Heritage Healthcare ( Site 1806)
Santa Rosa, California, United States
University of Colorado Cancer Center ( Site 1838)
Aurora, Colorado, United States
MedStar Washington Hospital Center ( Site 2062)
Washington D.C., District of Columbia, United States
George Washington University Medical Faculty Associates ( Site 2035)
Washington D.C., District of Columbia, United States
University of Florida ( Site 1832)
Gainesville, Florida, United States
University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008)
Miami, Florida, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 2054)
Orlando, Florida, United States
Orlando Health Cancer Institute ( Site 2061)
Orlando, Florida, United States
Saint Alphonsus Regional Medical Center ( Site 2021)
Boise, Idaho, United States
Beacon Cancer Care ( Site 2052)
Post Falls, Idaho, United States
Rush University Medical Center ( Site 1823)
Chicago, Illinois, United States
NorthShore University HealthSystem ( Site 1812)
Evanston, Illinois, United States
Loyola University Medical Center [Maywood, IL] ( Site 1817)
Maywood, Illinois, United States
University of Kansas Cancer Center ( Site 2004)
Westwood, Kansas, United States
University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069)
Lexington, Kentucky, United States
Ochsner Cancer Institute ( Site 2045)
New Orleans, Louisiana, United States
University of Maryland ( Site 2031)
Baltimore, Maryland, United States
Dana Farber Cancer Center ( Site 1873)
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center ( Site 1875)
Worcester, Massachusetts, United States
Karmanos Cancer Institute ( Site 1870)
Detroit, Michigan, United States
Henry Ford Health System ( Site 1803)
Detroit, Michigan, United States
Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016)
Edina, Minnesota, United States
University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058)
Columbia, Missouri, United States
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897)
Springfield, Missouri, United States
Washington University School of Medicine ( Site 1800)
St Louis, Missouri, United States
St. Vincent Healthcare Frontier Cancer Center ( Site 1818)
Billings, Montana, United States
Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039)
Middletown, New Jersey, United States
MSKCC-Bergen ( Site 2037)
Montvale, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 2071)
New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053)
Newark, New Jersey, United States
The University of New Mexico Comprehensive Cancer Center ( Site 1882)
Albuquerque, New Mexico, United States
Erie County Medical Center ( Site 2047)
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038)
Commack, New York, United States
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041)
Harrison, New York, United States
Monter Cancer Center ( Site 2060)
Lake Success, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 1857)
New York, New York, United States
Weill Cornell Medical College ( Site 2050)
New York, New York, United States
Northwell Health Cancer Institute ( Site 2030)
New York, New York, United States
Stony Brook University ( Site 2063)
Stony Brook, New York, United States
Montefiore Einstein Center ( Site 2028)
The Bronx, New York, United States
Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040)
Uniondale, New York, United States
Levine Cancer Institute ( Site 2003)
Charlotte, North Carolina, United States
Wake Forest Compenhensive Cancer Center ( Site 2029)
Winston-Salem, North Carolina, United States
Sanford Health Roger Maris Cancer Center ( Site 2034)
Fargo, North Dakota, United States
University Hospitals ( Site 2032)
Cleveland, Ohio, United States
The Ohio State University ( Site 2012)
Columbus, Ohio, United States
Providence Portland Medical Center ( Site 1843)
Portland, Oregon, United States
Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022)
Portland, Oregon, United States
Oregon Health Science University ( Site 1871)
Portland, Oregon, United States
St. Luke's University Health Network ( Site 1801)
Bethlehem, Pennsylvania, United States
Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059)
Philadelphia, Pennsylvania, United States
Allegheny General Hospital ( Site 1833)
Pittsburgh, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic ( Site 1859)
Sioux Falls, South Dakota, United States
Avera Cancer Institute- Research ( Site 2070)
Sioux Falls, South Dakota, United States
Henry Joyce Cancer Clinic ( Site 1827)
Nashville, Tennessee, United States
UT Southwestern Medical Center ( Site 1841)
Dallas, Texas, United States
USA Clinical Trials ( Site 2068)
San Antonio, Texas, United States
University of Utah, Huntsman Cancer Institute ( Site 1855)
Salt Lake City, Utah, United States
University of Vermont Medical Center ( Site 2009)
Burlington, Vermont, United States
UVA Health System - Emily Couric Cancer Center ( Site 1826)
Charlottesville, Virginia, United States
Inova Schar Cancer Institute ( Site 2026)
Fairfax, Virginia, United States
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865)
Seattle, Washington, United States
Hospital Universitario Austral ( Site 0009)
Pilar, Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0019)
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Britanico de Buenos Aires ( Site 0012)
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
Fundacion Estudios Clinicos-Oncology ( Site 0017)
Rosario, Santa Fe Province, Argentina
Sanatorio Britanico ( Site 0013)
Rosario, Santa Fe Province, Argentina
Instituto de Oncologia de Rosario ( Site 0002)
Rosario, Santa Fe Province, Argentina
Hospital Provincial del Centenario ( Site 0008)
Rosario, Santa Fe Province, Argentina
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0016)
Buenos Aires, Argentina
Hospital Aleman Buenos Aires Argentina ( Site 0004)
Buenos Aires, Argentina
Instituto de Oncología Angel Roffo ( Site 0003)
Buenos Aires, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010)
San Juan, Argentina
The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051)
Westmead, New South Wales, Australia
Royal Brisbane and Women s Hospital ( Site 0050)
Herston, Queensland, Australia
Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902)
Graz, Styria, Austria
Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901)
Linz, Upper Austria, Austria
Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900)
Salzburg, Austria
Medizinische Universität Wien ( Site 1903)
Vienna, Austria
Hopital de Jolimont ( Site 0103)
Haine-Saint-Paul, Hainaut, Belgium
UZ Gent ( Site 0101)
Ghent, Oost-Vlaanderen, Belgium
AZ Nikolaas ( Site 0104)
Sint-Niklaas, Oost-Vlaanderen, Belgium
Centro Regional Integrado de Oncologia ( Site 0160)
Fortaleza, Ceará, Brazil
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155)
Salvador, Estado de Bahia, Brazil
Hospital Marcio Cunha-Unidade de Pesquisa Clínica ( Site 0177)
Ipatinga, Minas Gerais, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 0171)
Natal, Rio Grande do Norte, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0165)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Base de Sao Jose de Rio Preto ( Site 0153)
São José do Rio Preto, São Paulo, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169)
Rio de Janeiro, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167)
São Paulo, Brazil
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0175)
São Paulo, Brazil
Cross Cancer Institute ( Site 0201)
Edmonton, Alberta, Canada
Sunnybrook Research Institute ( Site 0211)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario, Canada
McGill University Health Centre ( Site 0210)
Montreal, Quebec, Canada
CIUSSS de l'Estrie-CHUS ( Site 0209)
Sherbrooke, Quebec, Canada
Fundacion Arturo Lopez Perez FALP ( Site 0251)
Santiago, Region M. de Santiago, Chile
Clinica de la Costa S.A.S. ( Site 0307)
Barranquilla, Atlántico, Colombia
Centro de Investigacion Clinica del Country ( Site 0304)
Bogotá, Bogota D.C., Colombia
Oncologos del Occidente S.A. ( Site 0310)
Pereira, Risaralda Department, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0300)
Cali, Valle del Cauca Department, Colombia
Centre Antoine Lacassagne ( Site 0351)
Nice, Alpes-Maritimes, France
Hopital de la Timone ( Site 0356)
Marseille, Bouches-du-Rhone, France
Institut Claudius Regaud IUCT Oncopole ( Site 0355)
Toulouse, Haute-Garonne, France
Institut Gustave Roussy ( Site 0353)
Villejuif, Val-de-Marne, France
Institut Sainte Catherine ( Site 0352)
Avignon, Vaucluse, France
Hopital Europeen Georges Pompidou ( Site 0358)
Paris, France
Institut Curie ( Site 0350)
Paris, France
Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401)
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm ( Site 0402)
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen-Strahlenklinik ( Site 0412)
Erlangen, Bavaria, Germany
Klinikum rechts der Isar der Technischen Universitaet ( Site 0409)
Munich, Bavaria, Germany
Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405)
München, Bavaria, Germany
Universitaetsklinikum Frankfurt ( Site 0403)
Frankfurt am Main, Hesse, Germany
Klinikum Kassel GmbH ( Site 0404)
Kassel, Hesse, Germany
Universitaetsklinikum Koeln ( Site 0413)
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein ( Site 0411)
Lübeck, Schleswig-Holstein, Germany
SRH Wald-Klinikum Gera GmbH ( Site 0406)
Gera, Thuringia, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0414)
Berlin, Germany
Universitaetsklinikum Hamburg Eppendorf ( Site 0407)
Hamburg, Germany
Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452)
Pécs, Baranya, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0450)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 0453)
Budapest, Hungary
Orszagos Onkologiai Intezet ( Site 0454)
Budapest, Hungary
St. James s Hospital ( Site 0500)
Dublin, Ireland
Rambam Health Care Campus-Oncology Division ( Site 0550)
Haifa, Israel
Hadassah Medical Center. Ein Kerem ( Site 0554)
Jerusalem, Israel
Rabin Medical Center ( Site 0552)
Petah Tikva, Israel
Chaim Sheba Medical Center. ( Site 0553)
Ramat Gan, Israel
Sourasky Medical Center ( Site 0551)
Tel Aviv, Israel
Aichi Cancer Center Hospital ( Site 0658)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 0661)
Kashiwa, Chiba, Japan
Hyogo Cancer Center ( Site 0656)
Akashi, Hyōgo, Japan
Kagawa University Hospital ( Site 0651)
Kita-gun, Kagawa-ken, Japan
Yokohama City University Hospital ( Site 0657)
Yokohama, Kanagawa, Japan
Chiba Cancer Center ( Site 0652)
Chiba, Japan
National Hospital Organization Kyushu Cancer Center ( Site 0660)
Fukuoka, Japan
Hiroshima University Hospital ( Site 0655)
Hiroshima, Japan
National Cancer Center Hospital ( Site 0650)
Tokyo, Japan
Tokyo Medical and Dental University Hospital ( Site 0654)
Tokyo, Japan
Tokyo Medical University Hospital ( Site 0659)
Tokyo, Japan
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905)
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warsaw, Masovian Voivodeship, Poland
Szpitale Pomorskie Sp. z o.o. ( Site 0935)
Gdynia, Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)
Gliwice, Silesian Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920)
Lodz, Łódź Voivodeship, Poland
Hospital de Braga ( Site 0951)
Braga, Portugal
CHLN Hospital Santa Maria ( Site 0952)
Lisbon, Portugal
Hospital CUF Descobertas ( Site 0953)
Lisbon, Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950)
Porto, Portugal
N.N. Blokhin NMRCO ( Site 1005)
Moscow, Moscow, Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000)
Kazan', Tatarstan, Respublika, Russia
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001)
Yaroslavl, Yaroslavl Oblast, Russia
Chonnam National University Hwasun Hospital ( Site 0705)
Hwasun Gun, Jeonranamdo, South Korea
National Cancer Center ( Site 0702)
Goyang-si, Kyonggi-do, South Korea
The Catholic University of Korea St. Vincent s Hospital ( Site 0704)
Gyeonggi-do, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 0703)
Seongnam-si, Kyonggi-do, South Korea
Severance Hospital, Yonsei University Health System ( Site 0701)
Seoul, South Korea
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204)
Badalona, Barcelona, Spain
ICO L Hospitalet ( Site 1208)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinico Universitario de Santiago ( Site 1207)
Santiago de Compostela, La Coruna, Spain
Hospital Vall D Hebron ( Site 1200)
Barcelona, Spain
Hospital Universitario La Paz ( Site 1201)
Madrid, Spain
Hospital Universitario Virgen del Rocio ( Site 1206)
Seville, Spain
Universitaetsspital Zurich ( Site 1923)
Zuerich, Canton of Aargau, Switzerland
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921)
Bellinzona, Canton Ticino, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 1920)
Geneva, Switzerland
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303)
Kaohsiung City, Taiwan
Taichung Veterans General Hospital ( Site 1301)
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 1302)
Tainan, Taiwan
National Taiwan University Hospital ( Site 1300)
Taipei, Taiwan
Clinical oncology dispensary of Dnipro ( Site 1706)
Dnipro, Dnipropetrovsk Oblast, Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1705)
Dnipro, Dnipropetrovsk Oblast, Ukraine
Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709)
Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
Ukrainian Center of Tomotherapy ( Site 1708)
Kropyvnitskiy, Kirovohrad Oblast, Ukraine
PP PPC Acinus Medical and Diagnostic Centre ( Site 1704)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
LISOD. Hospital ( Site 1707)
Pliuty, Kyiv Oblast, Ukraine
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703)
Kapitanivka Village, Kyivska Oblast, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 1702)
Kyiv, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 1701)
Kyiv, Ukraine
Addenbrooke's Hospital ( Site 1610)
Cambridge, Cambridgeshire, United Kingdom
Castle Hill Hospital ( Site 1601)
Cottingham-Hull, Kingston Upon Hull, United Kingdom
Guy s & St Thomas NHS Foundation Trust ( Site 1604)
London, London, City of, United Kingdom
Royal Marsden Hospital - Fulham Road London ( Site 1609)
London, London, City of, United Kingdom
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603)
London, London, City of, United Kingdom
Weston Park Hospital ( Site 1607)
Sheffield, United Kingdom