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ACTIVE NOT RECRUITING
NCT03765918
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Pembrolizumab 200 mg

200 mg administered IV infusion on Day 1 of each 21-day cycle

RADIATION

Radiotherapy 60 Gray

Low risk participants administered 2 Gray in 30 fractions. Administered using intensity modulated radiation therapy.

RADIATION

Radiotherapy 66 Gray

High risk participants administered 2 Gray in 33 fractions. Administered using intensity modulated radiation therapy.

RADIATION

Radiotherapy 70 Gray

Participants with gross residual disease administered 2 Gray in 35 fractions. Administered using intensity modulated radiation therapy.

DRUG

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