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)
NCT ID: NCT03765918
Last Updated: 2025-08-20
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
714 participants
INTERVENTIONAL
2018-12-17
2026-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Pembrolizumab 200 mg
200 mg administered IV infusion on Day 1 of each 21-day cycle
Radiotherapy 60 Gray
Low risk participants administered 2 Gray in 30 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 66 Gray
High risk participants administered 2 Gray in 33 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 70 Gray
Participants with gross residual disease administered 2 Gray in 35 fractions. Administered using intensity modulated radiation therapy.
Cisplatin 100 mg/m^2
100 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle
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).
Radiotherapy 60 Gray
Low risk participants administered 2 Gray in 30 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 66 Gray
High risk participants administered 2 Gray in 33 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 70 Gray
Participants with gross residual disease administered 2 Gray in 35 fractions. Administered using intensity modulated radiation therapy.
Cisplatin 100 mg/m^2
100 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle
Interventions
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Pembrolizumab 200 mg
200 mg administered IV infusion on Day 1 of each 21-day cycle
Radiotherapy 60 Gray
Low risk participants administered 2 Gray in 30 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 66 Gray
High risk participants administered 2 Gray in 33 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 70 Gray
Participants with gross residual disease administered 2 Gray in 35 fractions. Administered using intensity modulated radiation therapy.
Cisplatin 100 mg/m^2
100 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Moores Cancer Center ( Site 1885)
La Jolla, California, United States
University of Southern California Norris Comprehensive Cancer Center ( Site 1850)
Los Angeles, California, United States
Hoag Memoriall Hospital Presbyterian ( Site 2056)
Newport Beach, California, United States
UC Davis Health System ( Site 1864)
Sacramento, California, United States
St. Joseph Heritage Healthcare ( Site 1806)
Santa Rosa, California, United States
University of Colorado Cancer Center ( Site 1838)
Aurora, Colorado, United States
MedStar Washington Hospital Center ( Site 2062)
Washington D.C., District of Columbia, United States
George Washington University Medical Faculty Associates ( Site 2035)
Washington D.C., District of Columbia, United States
University of Florida ( Site 1832)
Gainesville, Florida, United States
University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008)
Miami, Florida, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 2054)
Orlando, Florida, United States
Orlando Health Cancer Institute ( Site 2061)
Orlando, Florida, United States
Saint Alphonsus Regional Medical Center ( Site 2021)
Boise, Idaho, United States
Beacon Cancer Care ( Site 2052)
Post Falls, Idaho, United States
Rush University Medical Center ( Site 1823)
Chicago, Illinois, United States
NorthShore University HealthSystem ( Site 1812)
Evanston, Illinois, United States
Loyola University Medical Center [Maywood, IL] ( Site 1817)
Maywood, Illinois, United States
University of Kansas Cancer Center ( Site 2004)
Westwood, Kansas, United States
University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069)
Lexington, Kentucky, United States
Ochsner Cancer Institute ( Site 2045)
New Orleans, Louisiana, United States
University of Maryland ( Site 2031)
Baltimore, Maryland, United States
Dana Farber Cancer Center ( Site 1873)
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center ( Site 1875)
Worcester, Massachusetts, United States
Karmanos Cancer Institute ( Site 1870)
Detroit, Michigan, United States
Henry Ford Health System ( Site 1803)
Detroit, Michigan, United States
Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016)
Edina, Minnesota, United States
University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058)
Columbia, Missouri, United States
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897)
Springfield, Missouri, United States
Washington University School of Medicine ( Site 1800)
St Louis, Missouri, United States
St. Vincent Healthcare Frontier Cancer Center ( Site 1818)
Billings, Montana, United States
Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039)
Middletown, New Jersey, United States
MSKCC-Bergen ( Site 2037)
Montvale, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 2071)
New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053)
Newark, New Jersey, United States
The University of New Mexico Comprehensive Cancer Center ( Site 1882)
Albuquerque, New Mexico, United States
Erie County Medical Center ( Site 2047)
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038)
Commack, New York, United States
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041)
Harrison, New York, United States
Monter Cancer Center ( Site 2060)
Lake Success, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 1857)
New York, New York, United States
Weill Cornell Medical College ( Site 2050)
New York, New York, United States
Northwell Health Cancer Institute ( Site 2030)
New York, New York, United States
Stony Brook University ( Site 2063)
Stony Brook, New York, United States
Montefiore Einstein Center ( Site 2028)
The Bronx, New York, United States
Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040)
Uniondale, New York, United States
Levine Cancer Institute ( Site 2003)
Charlotte, North Carolina, United States
Wake Forest Compenhensive Cancer Center ( Site 2029)
Winston-Salem, North Carolina, United States
Sanford Health Roger Maris Cancer Center ( Site 2034)
Fargo, North Dakota, United States
University Hospitals ( Site 2032)
Cleveland, Ohio, United States
The Ohio State University ( Site 2012)
Columbus, Ohio, United States
Providence Portland Medical Center ( Site 1843)
Portland, Oregon, United States
Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022)
Portland, Oregon, United States
Oregon Health Science University ( Site 1871)
Portland, Oregon, United States
St. Luke's University Health Network ( Site 1801)
Bethlehem, Pennsylvania, United States
Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059)
Philadelphia, Pennsylvania, United States
Allegheny General Hospital ( Site 1833)
Pittsburgh, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic ( Site 1859)
Sioux Falls, South Dakota, United States
Avera Cancer Institute- Research ( Site 2070)
Sioux Falls, South Dakota, United States
Henry Joyce Cancer Clinic ( Site 1827)
Nashville, Tennessee, United States
UT Southwestern Medical Center ( Site 1841)
Dallas, Texas, United States
USA Clinical Trials ( Site 2068)
San Antonio, Texas, United States
University of Utah, Huntsman Cancer Institute ( Site 1855)
Salt Lake City, Utah, United States
University of Vermont Medical Center ( Site 2009)
Burlington, Vermont, United States
UVA Health System - Emily Couric Cancer Center ( Site 1826)
Charlottesville, Virginia, United States
Inova Schar Cancer Institute ( Site 2026)
Fairfax, Virginia, United States
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865)
Seattle, Washington, United States
Hospital Universitario Austral ( Site 0009)
Pilar, Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0019)
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Britanico de Buenos Aires ( Site 0012)
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
Fundacion Estudios Clinicos-Oncology ( Site 0017)
Rosario, Santa Fe Province, Argentina
Sanatorio Britanico ( Site 0013)
Rosario, Santa Fe Province, Argentina
Instituto de Oncologia de Rosario ( Site 0002)
Rosario, Santa Fe Province, Argentina
Hospital Provincial del Centenario ( Site 0008)
Rosario, Santa Fe Province, Argentina
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0016)
Buenos Aires, , Argentina
Hospital Aleman Buenos Aires Argentina ( Site 0004)
Buenos Aires, , Argentina
Instituto de Oncología Angel Roffo ( Site 0003)
Buenos Aires, , Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010)
San Juan, , Argentina
The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051)
Westmead, New South Wales, Australia
Royal Brisbane and Women s Hospital ( Site 0050)
Herston, Queensland, Australia
Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902)
Graz, Styria, Austria
Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901)
Linz, Upper Austria, Austria
Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900)
Salzburg, , Austria
Medizinische Universität Wien ( Site 1903)
Vienna, , Austria
Hopital de Jolimont ( Site 0103)
Haine-Saint-Paul, Hainaut, Belgium
UZ Gent ( Site 0101)
Ghent, Oost-Vlaanderen, Belgium
AZ Nikolaas ( Site 0104)
Sint-Niklaas, Oost-Vlaanderen, Belgium
Centro Regional Integrado de Oncologia ( Site 0160)
Fortaleza, Ceará, Brazil
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155)
Salvador, Estado de Bahia, Brazil
Hospital Marcio Cunha-Unidade de Pesquisa Clínica ( Site 0177)
Ipatinga, Minas Gerais, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 0171)
Natal, Rio Grande do Norte, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0165)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Base de Sao Jose de Rio Preto ( Site 0153)
São José do Rio Preto, São Paulo, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169)
Rio de Janeiro, , Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167)
São Paulo, , Brazil
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0175)
São Paulo, , Brazil
Cross Cancer Institute ( Site 0201)
Edmonton, Alberta, Canada
Sunnybrook Research Institute ( Site 0211)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario, Canada
McGill University Health Centre ( Site 0210)
Montreal, Quebec, Canada
CIUSSS de l'Estrie-CHUS ( Site 0209)
Sherbrooke, Quebec, Canada
Fundacion Arturo Lopez Perez FALP ( Site 0251)
Santiago, Region M. de Santiago, Chile
Clinica de la Costa S.A.S. ( Site 0307)
Barranquilla, Atlántico, Colombia
Centro de Investigacion Clinica del Country ( Site 0304)
Bogotá, Bogota D.C., Colombia
Oncologos del Occidente S.A. ( Site 0310)
Pereira, Risaralda Department, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0300)
Cali, Valle del Cauca Department, Colombia
Centre Antoine Lacassagne ( Site 0351)
Nice, Alpes-Maritimes, France
Hopital de la Timone ( Site 0356)
Marseille, Bouches-du-Rhone, France
Institut Claudius Regaud IUCT Oncopole ( Site 0355)
Toulouse, Haute-Garonne, France
Institut Gustave Roussy ( Site 0353)
Villejuif, Val-de-Marne, France
Institut Sainte Catherine ( Site 0352)
Avignon, Vaucluse, France
Hopital Europeen Georges Pompidou ( Site 0358)
Paris, , France
Institut Curie ( Site 0350)
Paris, , France
Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401)
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm ( Site 0402)
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen-Strahlenklinik ( Site 0412)
Erlangen, Bavaria, Germany
Klinikum rechts der Isar der Technischen Universitaet ( Site 0409)
Munich, Bavaria, Germany
Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405)
München, Bavaria, Germany
Universitaetsklinikum Frankfurt ( Site 0403)
Frankfurt am Main, Hesse, Germany
Klinikum Kassel GmbH ( Site 0404)
Kassel, Hesse, Germany
Universitaetsklinikum Koeln ( Site 0413)
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein ( Site 0411)
Lübeck, Schleswig-Holstein, Germany
SRH Wald-Klinikum Gera GmbH ( Site 0406)
Gera, Thuringia, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0414)
Berlin, , Germany
Universitaetsklinikum Hamburg Eppendorf ( Site 0407)
Hamburg, , Germany
Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452)
Pécs, Baranya, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0450)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 0453)
Budapest, , Hungary
Orszagos Onkologiai Intezet ( Site 0454)
Budapest, , Hungary
St. James s Hospital ( Site 0500)
Dublin, , Ireland
Rambam Health Care Campus-Oncology Division ( Site 0550)
Haifa, , Israel
Hadassah Medical Center. Ein Kerem ( Site 0554)
Jerusalem, , Israel
Rabin Medical Center ( Site 0552)
Petah Tikva, , Israel
Chaim Sheba Medical Center. ( Site 0553)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 0551)
Tel Aviv, , Israel
Aichi Cancer Center Hospital ( Site 0658)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 0661)
Kashiwa, Chiba, Japan
Hyogo Cancer Center ( Site 0656)
Akashi, Hyōgo, Japan
Kagawa University Hospital ( Site 0651)
Kita-gun, Kagawa-ken, Japan
Yokohama City University Hospital ( Site 0657)
Yokohama, Kanagawa, Japan
Chiba Cancer Center ( Site 0652)
Chiba, , Japan
National Hospital Organization Kyushu Cancer Center ( Site 0660)
Fukuoka, , Japan
Hiroshima University Hospital ( Site 0655)
Hiroshima, , Japan
National Cancer Center Hospital ( Site 0650)
Tokyo, , Japan
Tokyo Medical and Dental University Hospital ( Site 0654)
Tokyo, , Japan
Tokyo Medical University Hospital ( Site 0659)
Tokyo, , Japan
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905)
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warsaw, Masovian Voivodeship, Poland
Szpitale Pomorskie Sp. z o.o. ( Site 0935)
Gdynia, Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)
Gliwice, Silesian Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920)
Lodz, Łódź Voivodeship, Poland
Hospital de Braga ( Site 0951)
Braga, , Portugal
CHLN Hospital Santa Maria ( Site 0952)
Lisbon, , Portugal
Hospital CUF Descobertas ( Site 0953)
Lisbon, , Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950)
Porto, , Portugal
N.N. Blokhin NMRCO ( Site 1005)
Moscow, Moscow, Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000)
Kazan', Tatarstan, Respublika, Russia
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001)
Yaroslavl, Yaroslavl Oblast, Russia
Chonnam National University Hwasun Hospital ( Site 0705)
Hwasun Gun, Jeonranamdo, South Korea
National Cancer Center ( Site 0702)
Goyang-si, Kyonggi-do, South Korea
The Catholic University of Korea St. Vincent s Hospital ( Site 0704)
Gyeonggi-do, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 0703)
Seongnam-si, Kyonggi-do, South Korea
Severance Hospital, Yonsei University Health System ( Site 0701)
Seoul, , South Korea
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204)
Badalona, Barcelona, Spain
ICO L Hospitalet ( Site 1208)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinico Universitario de Santiago ( Site 1207)
Santiago de Compostela, La Coruna, Spain
Hospital Vall D Hebron ( Site 1200)
Barcelona, , Spain
Hospital Universitario La Paz ( Site 1201)
Madrid, , Spain
Hospital Universitario Virgen del Rocio ( Site 1206)
Seville, , Spain
Universitaetsspital Zurich ( Site 1923)
Zuerich, Canton of Aargau, Switzerland
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921)
Bellinzona, Canton Ticino, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 1920)
Geneva, , Switzerland
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303)
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital ( Site 1301)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 1302)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 1300)
Taipei, , Taiwan
Clinical oncology dispensary of Dnipro ( Site 1706)
Dnipro, Dnipropetrovsk Oblast, Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1705)
Dnipro, Dnipropetrovsk Oblast, Ukraine
Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709)
Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
Ukrainian Center of Tomotherapy ( Site 1708)
Kropyvnitskiy, Kirovohrad Oblast, Ukraine
PP PPC Acinus Medical and Diagnostic Centre ( Site 1704)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
LISOD. Hospital ( Site 1707)
Pliuty, Kyiv Oblast, Ukraine
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703)
Kapitanivka Village, Kyivska Oblast, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 1702)
Kyiv, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 1701)
Kyiv, , Ukraine
Addenbrooke's Hospital ( Site 1610)
Cambridge, Cambridgeshire, United Kingdom
Castle Hill Hospital ( Site 1601)
Cottingham-Hull, Kingston Upon Hull, United Kingdom
Guy s & St Thomas NHS Foundation Trust ( Site 1604)
London, London, City of, United Kingdom
Royal Marsden Hospital - Fulham Road London ( Site 1609)
London, London, City of, United Kingdom
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603)
London, London, City of, United Kingdom
Weston Park Hospital ( Site 1607)
Sheffield, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trial Information
Plain Language Summary
Other Identifiers
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MK-3475-689
Identifier Type: OTHER
Identifier Source: secondary_id
2022-500254-41-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1274-2398
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-001139-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-689
Identifier Type: -
Identifier Source: org_study_id
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