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)

April 29, 2026 updated by: Merck Sharp & Dohme LLC

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)

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 Overview

Status

Active, not recruiting

Conditions

Head and Neck Neoplasms

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

714

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1118AAT
    - Hospital Aleman Buenos Aires Argentina ( Site 0004)
  - Buenos Aires, Argentina, C1417DTB
    - Instituto de Oncología Angel Roffo ( Site 0003)
  - Buenos Aires, Argentina, C1012AAR
    - IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0016)
  - San Juan, Argentina, J5402DIL
    - CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010)
- Buenos Aires
  - Pilar, Buenos Aires, Argentina, B1629AHJ
    - Hospital Universitario Austral ( Site 0009)
- Buenos Aires F.D.
  - Buenos Aires, Buenos Aires F.D., Argentina, C1431FWO
    - Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0019)
  - Ciudad de Buenos Aires, Buenos Aires F.D., Argentina, C1280AEB
    - Hospital Britanico de Buenos Aires ( Site 0012)
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, S2000CVB
    - Sanatorio Britanico ( Site 0013)
  - Rosario, Santa Fe Province, Argentina, S2000DEJ
    - Fundacion Estudios Clinicos-Oncology ( Site 0017)
  - Rosario, Santa Fe Province, Argentina, S2000KZE
    - Instituto de Oncologia de Rosario ( Site 0002)
  - Rosario, Santa Fe Province, Argentina, S2002KDS
    - Hospital Provincial del Centenario ( Site 0008)
Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051)
- Queensland
  - Herston, Queensland, Australia, 4029
    - Royal Brisbane and Women s Hospital ( Site 0050)
Austria
- - Salzburg, Austria, 5020
    - Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900)
  - Vienna, Austria, 1090
    - Medizinische Universität Wien ( Site 1903)
- Styria
  - Graz, Styria, Austria, 8036
    - Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902)
- Upper Austria
  - Linz, Upper Austria, Austria, 4010
    - Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901)
Belgium
- Hainaut
  - Haine-Saint-Paul, Hainaut, Belgium, 7100
    - Hopital de Jolimont ( Site 0103)
- Oost-Vlaanderen
  - Ghent, Oost-Vlaanderen, Belgium, 9000
    - UZ Gent ( Site 0101)
  - Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
    - AZ Nikolaas ( Site 0104)
Brazil
- - Rio de Janeiro, Brazil, 20231-050
    - Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169)
  - São Paulo, Brazil, 01246-000
    - Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167)
  - São Paulo, Brazil, 01321-001
    - BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0175)
- Ceará
  - Fortaleza, Ceará, Brazil, 60336-232
    - Centro Regional Integrado de Oncologia ( Site 0160)
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, 40050-410
    - Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155)
- Minas Gerais
  - Ipatinga, Minas Gerais, Brazil, 35162-189
    - Hospital Marcio Cunha-Unidade de Pesquisa Clínica ( Site 0177)
- Rio Grande do Norte
  - Natal, Rio Grande do Norte, Brazil, 59075-740
    - Liga Norte Riograndense Contra o Cancer ( Site 0171)
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 91359-200
    - Hospital Nossa Senhora da Conceicao ( Site 0165)
- São Paulo
  - São José do Rio Preto, São Paulo, Brazil, 15090-000
    - Hospital de Base de Sao Jose de Rio Preto ( Site 0153)
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute ( Site 0201)
- Ontario
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Cancer Centre ( Site 0202)
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Research Institute ( Site 0211)
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Centre ( Site 0210)
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - CIUSSS de l'Estrie-CHUS ( Site 0209)
Chile
- Region M. de Santiago
  - Santiago, Region M. de Santiago, Chile, 7500921
    - Fundacion Arturo Lopez Perez FALP ( Site 0251)
Colombia
- Atlántico
  - Barranquilla, Atlántico, Colombia, 080020
    - Clinica de la Costa S.A.S. ( Site 0307)
- Bogota D.C.
  - Bogotá, Bogota D.C., Colombia, 110221
    - Centro de Investigacion Clinica del Country ( Site 0304)
- Risaralda Department
  - Pereira, Risaralda Department, Colombia, 661002
    - Oncologos del Occidente S.A. ( Site 0310)
- Valle del Cauca Department
  - Cali, Valle del Cauca Department, Colombia, 760042
    - Centro Medico Imbanaco de Cali S.A ( Site 0300)
France
- - Paris, France, 75015
    - Hopital Europeen Georges Pompidou ( Site 0358)
  - Paris, France, 75248
    - Institut Curie ( Site 0350)
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06189
    - Centre Antoine Lacassagne ( Site 0351)
- Bouches-du-Rhone
  - Marseille, Bouches-du-Rhone, France, 13385
    - Hopital de la Timone ( Site 0356)
- Haute-Garonne
  - Toulouse, Haute-Garonne, France, 31059
    - Institut Claudius Regaud IUCT Oncopole ( Site 0355)
- Val-de-Marne
  - Villejuif, Val-de-Marne, France, 94800
    - Institut Gustave Roussy ( Site 0353)
- Vaucluse
  - Avignon, Vaucluse, France, 84918
    - Institut Sainte Catherine ( Site 0352)
Germany
- - Berlin, Germany, 12203
    - Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0414)
  - Hamburg, Germany, 20246
    - Universitaetsklinikum Hamburg Eppendorf ( Site 0407)
- Baden-Wurttemberg
  - Tübingen, Baden-Wurttemberg, Germany, 72076
    - Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401)
  - Ulm, Baden-Wurttemberg, Germany, 89075
    - Universitaetsklinikum Ulm. ( Site 0402)
- Bavaria
  - Erlangen, Bavaria, Germany, 91054
    - Universitaetsklinikum Erlangen-Strahlenklinik ( Site 0412)
  - Munich, Bavaria, Germany, 81675
    - Klinikum rechts der Isar der Technischen Universitaet ( Site 0409)
  - München, Bavaria, Germany, 81675
    - Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405)
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60590
    - Universitaetsklinikum Frankfurt ( Site 0403)
  - Kassel, Hesse, Germany, 34125
    - Klinikum Kassel GmbH ( Site 0404)
- North Rhine-Westphalia
  - Cologne, North Rhine-Westphalia, Germany, 50937
    - Universitaetsklinikum Koeln ( Site 0413)
- Schleswig-Holstein
  - Lübeck, Schleswig-Holstein, Germany, 23538
    - Universitätsklinikum Schleswig-Holstein ( Site 0411)
- Thuringia
  - Gera, Thuringia, Germany, 07548
    - SRH Wald-Klinikum Gera GmbH ( Site 0406)
Hungary
- - Budapest, Hungary, 1062
    - Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 0453)
  - Budapest, Hungary, 1122
    - Orszagos Onkologiai Intezet-Sugarterapias Kozpont ( Site 0454)
- Baranya
  - Pécs, Baranya, Hungary, 7621
    - Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452)
- Jász-Nagykun-Szolnok
  - Szolnok, Jász-Nagykun-Szolnok, Hungary, 5004
    - Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0450)
Ireland
- - Dublin, Ireland, Dublin 8
    - St. James s Hospital ( Site 0500)
Israel
- - Haifa, Israel, 3109601
    - Rambam Health Care Campus-Oncology Division ( Site 0550)
  - Jerusalem, Israel, 9112001
    - Hadassah Medical Center. Ein Kerem ( Site 0554)
  - Petah Tikva, Israel, 4963211
    - Rabin Medical Center ( Site 0552)
  - Ramat Gan, Israel, 5265601
    - Chaim Sheba Medical Center. ( Site 0553)
  - Tel Aviv, Israel, 6423906
    - Sourasky Medical Center ( Site 0551)
Japan
- - Chiba, Japan, 260-8717
    - Chiba Cancer Center ( Site 0652)
  - Fukuoka, Japan, 811-1395
    - National Hospital Organization Kyushu Cancer Center ( Site 0660)
  - Hiroshima, Japan, 734-8551
    - Hiroshima University Hospital ( Site 0655)
  - Tokyo, Japan, 104-0045
    - National Cancer Center Hospital ( Site 0650)
  - Tokyo, Japan, 160-0023
    - Tokyo Medical University Hospital ( Site 0659)
  - Tokyo, Japan, 113-8519
    - Institute of Science Tokyo Hospital ( Site 0654)
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 464-8681
    - Aichi Cancer Center ( Site 0658)
- Chiba
  - Kashiwa, Chiba, Japan, 277-8577
    - National Cancer Center Hospital East ( Site 0661)
- Hyōgo
  - Akashi, Hyōgo, Japan, 673-8558
    - Hyogo Cancer Center ( Site 0656)
- Kagawa-ken
  - Kita-gun, Kagawa-ken, Japan, 761-0793
    - Kagawa University Hospital ( Site 0651)
- Tokyo
  - Minato, Tokyo, Japan, 107-0052
    - Yokohama City University Hospital ( Site 0657)
Poland
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 31-826
    - Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905)
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 02-781
    - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0940)
- Pomeranian Voivodeship
  - Gdynia, Pomeranian Voivodeship, Poland, 81-159
    - Szpitale Pomorskie Sp. z o.o. ( Site 0935)
- Silesian Voivodeship
  - Gliwice, Silesian Voivodeship, Poland, 44-101
    - Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)
- Łódź Voivodeship
  - Lodz, Łódź Voivodeship, Poland, 93-513
    - Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920)
Portugal
- - Braga, Portugal, 4710-243
    - Unidade Local de Saude de Braga - Hospital de Braga ( Site 0951)
  - Lisbon, Portugal, 1649-035
    - Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 0952)
  - Lisbon, Portugal, 1998-018
    - Hospital CUF Descobertas ( Site 0953)
  - Porto, Portugal, 4200-072
    - Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950)
Russia
- Moscow
  - Moscow, Moscow, Russia, 115478
    - N.N. Blokhin NMRCO ( Site 1005)
- Tatarstan, Respublika
  - Kazan', Tatarstan, Respublika, Russia, 420029
    - Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 1000)
- Yaroslavl Oblast
  - Yaroslavl, Yaroslavl Oblast, Russia, 150054
    - Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001)
South Korea
- - Seoul, South Korea, 03722
    - Severance Hospital, Yonsei University Health System ( Site 0701)
- Jeonranamdo
  - Hwasun Gun, Jeonranamdo, South Korea, 58128
    - Chonnam National University Hwasun Hospital ( Site 0705)
- Kyonggi-do
  - Goyang-si, Kyonggi-do, South Korea, 10408
    - National Cancer Center ( Site 0702)
  - Seongnam-si, Kyonggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital ( Site 0703)
  - Suwon, Kyonggi-do, South Korea, 16247
    - The Catholic University of Korea St. Vincent s Hospital ( Site 0704)
Spain
- - Barcelona, Spain, 08035
    - Hospital Vall D Hebron ( Site 1200)
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz ( Site 1201)
  - Seville, Spain, 41013
    - Hospital Universitario Virgen del Rocio ( Site 1206)
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204)
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08908
    - ICO L Hospitalet ( Site 1208)
- La Coruna
  - Santiago de Compostela, La Coruna, Spain, 15706
    - Hospital Clinico Universitario de Santiago ( Site 1207)
Switzerland
- - Geneva, Switzerland, 1211
    - Hopitaux Universitaires de Geneve HUG ( Site 1920)
- Canton Ticino
  - Bellinzona, Canton Ticino, Switzerland, 6500
    - Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921)
- Canton of Aargau
  - Zuerich, Canton of Aargau, Switzerland, 8091
    - Universitaetsspital Zurich ( Site 1923)
Taiwan
- - Kaohsiung City, Taiwan, 833
    - Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303)
  - Taichung, Taiwan, 40705
    - Taichung Veterans General Hospital ( Site 1301)
  - Tainan, Taiwan, 704
    - National Cheng Kung University Hospital ( Site 1302)
  - Taipei, Taiwan, 10002
    - National Taiwan University Hospital ( Site 1300)
Ukraine
- - Kyiv, Ukraine, 03115
    - Kyiv City Clinical Oncology Centre ( Site 1701)
- Dnipropetrovsk Oblast
  - Dnipro, Dnipropetrovsk Oblast, Ukraine, 49055
    - Clinical oncology dispensary of Dnipro ( Site 1706)
  - Dnipro, Dnipropetrovsk Oblast, Ukraine, 49102
    - Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1705)
  - Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine, 49005
    - Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709)
- Kirovohrad Oblast
  - Kropyvnitskiy, Kirovohrad Oblast, Ukraine, 25011
    - Ukrainian Center of Tomotherapy ( Site 1708)
  - Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25006
    - PP PPC Acinus Medical and Diagnostic Centre ( Site 1704)
- Kyiv Oblast
  - Pliuty, Kyiv Oblast, Ukraine, 08720
    - LISOD. Hospital ( Site 1707)
- Kyivska Oblast
  - Kapitanivka Village, Kyivska Oblast, Ukraine, 08111
    - Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703)
  - Kyiv, Kyivska Oblast, Ukraine, 03022
    - SNPE National Cancer Institute ( Site 1702)
United Kingdom
- - Sheffield, United Kingdom, S10 2SJ
    - Weston Park Hospital ( Site 1607)
- Cambridgeshire
  - Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
    - Addenbrooke's Hospital ( Site 1610)
- Kingston Upon Hull
  - Cottingham-Hull, Kingston Upon Hull, United Kingdom, HU16 5JQ
    - Castle Hill Hospital ( Site 1601)
- London, City of
  - London, London, City of, United Kingdom, SE1 9RT
    - Guy s & St Thomas NHS Foundation Trust ( Site 1604)
  - London, London, City of, United Kingdom, SW3 6JJ
    - Royal Marsden Hospital - Fulham Road London ( Site 1609)
  - London, London, City of, United Kingdom, W6 8RF
    - Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603)
United States
- California
  - La Jolla, California, United States, 92093-0698
    - Moores Cancer Center ( Site 1885)
  - Los Angeles, California, United States, 90033
    - University of Southern California Norris Comprehensive Cancer Center ( Site 1850)
  - Newport Beach, California, United States, 92663
    - Hoag Memoriall Hospital Presbyterian ( Site 2056)
  - Sacramento, California, United States, 95817
    - UC Davis Health System ( Site 1864)
  - Santa Rosa, California, United States, 95403
    - St. Joseph Heritage Healthcare ( Site 1806)
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Cancer Center ( Site 1838)
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20010
    - MedStar Washington Hospital Center ( Site 2062)
  - Washington D.C., District of Columbia, United States, 20037
    - George Washington University Medical Faculty Associates ( Site 2035)
- Florida
  - Gainesville, Florida, United States, 32608
    - University of Florida ( Site 1832)
  - Miami, Florida, United States, 33136
    - University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008)
  - Orlando, Florida, United States, 32806
    - Orlando Health Cancer Institute ( Site 2061)
  - Orlando, Florida, United States, 32804
    - AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 2054)
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Regional Medical Center ( Site 2021)
  - Post Falls, Idaho, United States, 83854
    - Beacon Cancer Care ( Site 2052)
- Illinois
  - Chicago, Illinois, United States, 60607
    - Rush University Medical Center ( Site 1823)
  - Evanston, Illinois, United States, 60201
    - NorthShore University HealthSystem ( Site 1812)
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center [Maywood, IL] ( Site 1817)
- Kansas
  - Westwood, Kansas, United States, 66205
    - University of Kansas Cancer Center ( Site 2004)
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069)
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Cancer Institute ( Site 2045)
- Maryland
  - Baltimore, Maryland, United States, 21201
    - University of Maryland ( Site 2031)
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Dana Farber Cancer Center ( Site 1873)
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Memorial Medical Center ( Site 1875)
- Michigan
  - Detroit, Michigan, United States, 48201
    - Karmanos Cancer Institute ( Site 1870)
  - Detroit, Michigan, United States, 48202
    - Henry Ford Health System ( Site 1803)
- Minnesota
  - Edina, Minnesota, United States, 55435
    - Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016)
- Missouri
  - Columbia, Missouri, United States, 65212
    - University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058)
  - Springfield, Missouri, United States, 65804
    - Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897)
  - St Louis, Missouri, United States, 63110
    - Washington University School of Medicine ( Site 1800)
- Montana
  - Billings, Montana, United States, 59102
    - St. Vincent Healthcare Frontier Cancer Center ( Site 1818)
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036)
  - Middletown, New Jersey, United States, 07748
    - Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039)
  - Montvale, New Jersey, United States, 07645
    - MSKCC-Bergen ( Site 2037)
  - New Brunswick, New Jersey, United States, 08903
    - Rutgers Cancer Institute of New Jersey ( Site 2071)
  - Newark, New Jersey, United States, 07103
    - Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053)
- New Mexico
  - Albuquerque, New Mexico, United States, 87131-0001
    - The University of New Mexico Comprehensive Cancer Center ( Site 1882)
- New York
  - Buffalo, New York, United States, 14215
    - Erie County Medical Center ( Site 2047)
  - Commack, New York, United States, 11725
    - Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038)
  - Harrison, New York, United States, 10604
    - Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041)
  - Lake Success, New York, United States, 11042
    - Monter Cancer Center ( Site 2060)
  - New York, New York, United States, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014)
  - New York, New York, United States, 10065
    - Weill Cornell Medical College ( Site 2050)
  - New York, New York, United States, 10075
    - Northwell Health Cancer Institute ( Site 2030)
  - New York, New York, United States, 10021
    - Memorial Sloan Kettering Cancer Center ( Site 1857)
  - Stony Brook, New York, United States, 11794
    - Stony Brook University ( Site 2063)
  - The Bronx, New York, United States, 10467
    - Montefiore Einstein Center ( Site 2028)
  - Uniondale, New York, United States, 11553
    - Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040)
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Levine Cancer Institute ( Site 2003)
  - Winston-Salem, North Carolina, United States, 27357
    - Wake Forest Compenhensive Cancer Center ( Site 2029)
- North Dakota
  - Fargo, North Dakota, United States, 58122
    - Sanford Health Roger Maris Cancer Center ( Site 2034)
- Ohio
  - Cleveland, Ohio, United States, 44106
    - University Hospitals ( Site 2032)
  - Columbus, Ohio, United States, 43210
    - The Ohio State University ( Site 2012)
- Oregon
  - Portland, Oregon, United States, 97220
    - Providence Portland Medical Center ( Site 1843)
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022)
  - Portland, Oregon, United States, 97239
    - Oregon Health Science University ( Site 1871)
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Luke's University Health Network ( Site 1801)
  - Philadelphia, Pennsylvania, United States, 19107
    - Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059)
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny General Hospital ( Site 1833)
- South Dakota
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic ( Site 1859)
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute- Research ( Site 2070)
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Henry Joyce Cancer Clinic ( Site 1827)
- Texas
  - Dallas, Texas, United States, 75390
    - UT Southwestern Medical Center ( Site 1841)
  - San Antonio, Texas, United States, 78229
    - USA Clinical Trials ( Site 2068)
- Utah
  - Salt Lake City, Utah, United States, 84112-5550
    - University of Utah, Huntsman Cancer Institute ( Site 1855)
- Vermont
  - Burlington, Vermont, United States, 05401
    - University of Vermont Medical Center ( Site 2009)
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - UVA Health System - Emily Couric Cancer Center ( Site 1826)
  - Fairfax, Virginia, United States, 22031
    - Inova Schar Cancer Institute ( Site 2026)
- Washington
  - Seattle, Washington, United States, 98109
    - Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab + Standard of Care (SOC) Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).	Drug: Cisplatin 100 mg/m^2 100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle Other Names: Platinol® Platinol-AQ® 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. Biological: Pembrolizumab 200 mg 200 mg administered IV infusion on Day 1 of each 21-day cycle Other Names: MK-3475 KEYTRUDA®
Active Comparator: Standard of Care (SOC) Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).	Drug: Cisplatin 100 mg/m^2 100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle Other Names: Platinol® Platinol-AQ® 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.

Participant Group / Arm

Intervention / Treatment

Experimental: Pembrolizumab + Standard of Care (SOC)

Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.

Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).

Drug: Cisplatin 100 mg/m^2

100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle

Other Names:

Platinol®
Platinol-AQ®

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.

Biological: Pembrolizumab 200 mg

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

Other Names:

MK-3475
KEYTRUDA®

Active Comparator: Standard of Care (SOC)

Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).

Drug: Cisplatin 100 mg/m^2

100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle

Other Names:

Platinol®
Platinol-AQ®

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free Survival (EFS) Time Frame: 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.	Up to ~66 months
EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 Time Frame: 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.	Up to ~66 months
EFS in Participants With PD-L1 CPS ≥1 Time Frame: 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.	Up to ~66 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Pathological Response (mPR) Rate Time Frame: Up to ~66 months	mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by blinded independent pathologist review (BIPR) at the time of definitive surgery in all randomized participants was presented.	Up to ~66 months
mPR Rate in Participants With PD-L1 CPS ≥10 Time Frame: Up to ~66 months	mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥10 was presented.	Up to ~66 months
mPR Rate in Participants With PD-L1 CPS ≥1 Time Frame: Up to ~66 months	mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥1 was presented.	Up to ~66 months
Pathological Complete Response (pCR) Rate Time Frame: Up to ~66 months	pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants was presented.	Up to ~66 months
pCR Rate in Participants With PD-L1 CPS ≥10 Time Frame: Up to ~66 months	pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥10 was presented.	Up to ~66 months
pCR Rate in Participants With PD-L1 CPS ≥1 Time Frame: Up to ~66 months	pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥1 was presented.	Up to ~66 months
Neoadjuvant Treatment: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Scale Combined Score at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QOL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.	Baseline and Week 25
Adjuvant Treatment: Change in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented.	Baseline and Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.	Baseline and Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented.	Baseline and Week 51
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented.	Baseline and Week 51
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.	Baseline and Week 51
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.	Baseline and Week 51
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-Head and Neck Module 35 [H&N35] (Items 35-38) Swallowing Combined Score at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented.	Baseline and Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.	Baseline and Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.	Baseline and Week 51
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented.	Baseline and Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.	Baseline and Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.	Baseline and Week 51
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 4 Time Frame: Baseline and Week 4	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.	Baseline and Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 6 Time Frame: Baseline and Week 6	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.	Baseline and Week 6
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 25 Time Frame: Baseline and Week 25	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.	Baseline and Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented.	Baseline and Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.	Baseline and Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 51 Time Frame: Baseline and Week 51	EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.	Baseline and Week 51
Overall Survival (OS) Time Frame: Up to ~92 months	OS was defined as the time from randomization to death due to any cause. OS for all randomized participants was presented.	Up to ~92 months
OS in Participants With PD-L1 CPS ≥10 Time Frame: Up to ~92 months	OS was defined as the time from randomization to death due to any cause. OS for all randomized participants with PD-L1 CPS ≥10 was presented.	Up to ~92 months
OS in Participants With PD-L1 CPS ≥1 Time Frame: Up to ~92 months	OS was defined as the time from randomization to death due to any cause. OS for all randomized participants with PD-L1 CPS ≥1 was presented.	Up to ~92 months
Number of Participants Who Experienced an Adverse Event (AE) Time Frame: Up to ~92 months	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported.	Up to ~92 months
Number of Participants Who Discontinued Study Treatment Due to an AE Time Frame: Up to ~92 months	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who discontinued study treatment due to an AE was reported.	Up to ~92 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Uppaluri R, Haddad RI, Tao Y, Le Tourneau C, Lee NY, Westra W, Chernock R, Tahara M, Harrington KJ, Klochikhin AL, Brana I, Vasconcelos Alves G, Hughes BGM, Oliva M, Pinto Figueiredo Lima I, Ueda T, Rutkowski T, Schroeder U, Mauz PS, Fuereder T, Laban S, Oridate N, Popovtzer A, Mach N, Korobko Y, Costa DA, Hooda-Nehra A, Rodriguez CP, Bell RB, Manschot C, Benjamin K, Gumuscu B, Adkins D; KEYNOTE-689 Investigators. Neoadjuvant and Adjuvant Pembrolizumab in Locally Advanced Head and Neck Cancer. N Engl J Med. 2025 Jul 3;393(1):37-50. doi: 10.1056/NEJMoa2415434. Epub 2025 Jun 18.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2018

Primary Completion (Actual)

July 25, 2024

Study Completion (Estimated)

September 10, 2026

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

3475-689
MK-3475-689 (Other Identifier: MSD)
2022-500254-41-00 (Registry Identifier: EU CT)
2017-001139-38 (EudraCT Number)
U1111-1274-2398 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Neoplasms

Robert Ferris
Amgen

Completed

Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer

Head and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditions

United States
Assiut University

Recruiting

Head and Neck Cancer in Children: A Retrospective Study

Head and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and Neck

Egypt
University of California, San Francisco

Active, not recruiting

Post-Radiation Oral Health in Underserved Head and Neck Cancer Patients

Head and Neck Cancer | Head and Neck Neoplasms | Head and Neck Carcinoma

United States
AZ Sint-Jan AV

Active, not recruiting

Value of Geriatric Screening to Predict Postoperative Morbidity for Head and Neck Cancer (GEROP)

Head and Neck

Belgium
Yale University

Recruiting

Skin Color Matching in Head and Neck Reconstructive Surgery (RECOLOR-HN)

Head and Neck Cancer | Head and Neck Trauma

United States
IntraGel Therapeutics

Recruiting

A Single Arm, Prospective, Open Label, Multi Center, Phase Ib Study to Evaluate the Safety, Tolerability and Initial Efficacy of a Single Intra-tumoral Injection of IntraGel's Polymer-based Cisplatin-loaded Gel (TumoCure) in Subjects With Progressive or Radio-resistant Primary Head and Neck Tumor

Head and Neck Cancer

Israel
Regina Elena Cancer Institute

Completed

Repeatability and Reproducibility of the ADC Map in Head and Neck Cancer. Prospective Multicenter Study (ADC/SCC oss)

Head and Neck Carcinoma

Italy
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Active, not recruiting

Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy

Head and Neck Carcinoma

United States
Gustave Roussy, Cancer Campus, Grand Paris

Completed

Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors (TORS)

Head and Neck Cancer

France
Sidney Kimmel Cancer Center at Thomas Jefferson...

Completed

Remote Activity Monitored by Fitbit Charge 3 in Investigating Daily Step and Sleep Data in Participants With Head and Neck Cancer Undergoing Radiation Therapy

Head and Neck Carcinoma

United States

Clinical Trials on Cisplatin 100 mg/m^2

AIO-Studien-gGmbH
Taiho Pharmaceutical Co., Ltd.; Nordic Pharma SAS

Completed

Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer (MATEO)

Esophageal Neoplasms | Gastric Adenocarcinoma | Esophageal Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Gastric Neoplasm | Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction

Germany
CicloMed LLC
Cmed Clinical Services

Completed

Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors

Advanced Solid Tumors

United States
Merck Sharp & Dohme LLC

Completed

Study of Pembrolizumab (MK-3475) Monotherapy in Advanced Solid Tumors and Pembrolizumab Combination Therapy in Advanced Non-small Cell Lung Cancer/ Extensive-disease Small Cell Lung Cancer (MK-3475-011/KEYNOTE-011)

Small Cell Lung Cancer | Solid Tumor | Non-small Cell Lung Cancer
Chengdu Zenitar Biomedical Technology Co., Ltd

Active, not recruiting

Study of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

Diffuse Large B Cell Lymphoma，DLBCL

China
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany

Completed

First-in-Human Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-984 in Combination With Chemotherapy

Advanced Solid Tumor

United States
Millennium Pharmaceuticals, Inc.

Completed

A Study of Pevonedistat in Adult East Asian Participants

Myelodysplastic Syndromes | Leukemia, Myeloid, Acute

Japan, Taiwan, Korea, Republic of
Rakuten Medical, Inc.

Completed

Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer

Recurrent Head and Neck Cancer

United States
Bangabandhu Sheikh Mujib Medical University, Dhaka...

Completed

An Experimental Study to Compare Treatment Response and Toxicities of Concurrent Chemoradiation With Weekly Cisplatin and Three Weekly Cisplatin in Locally Advanced Head and Neck Cancer. (HNC)

Head and Neck Squamous Cell Carcinoma

Bangladesh
Corcept Therapeutics

Recruiting

Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma

Adenocarcinoma | Carcinoma, Pancreatic Ductal

United States
AstraZeneca

Completed

AZD5069 Neutrophil Function Study

Chemokine Receptor 2 (CXCR2) Antagonist

United Kingdom

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)

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)

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Head and Neck Neoplasms

Clinical Trials on Cisplatin 100 mg/m^2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations