Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)
A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)
5 other identifiers
interventional
804
20 countries
145
Brief Summary
The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2017
Longer than P75 for phase_3
145 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2017
CompletedFirst Posted
Study publicly available on registry
February 2, 2017
CompletedStudy Start
First participant enrolled
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedResults Posted
Study results publicly available
June 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2024
CompletedFebruary 4, 2026
December 1, 2025
5.2 years
February 1, 2017
May 12, 2023
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-free Survival (EFS)
EFS was defined as the time from date of randomization to the date of first record of any of the following events: death due to any cause; progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR) or biopsy as indicated for locoregional progression or recurrence or distant metastasis. As well as the first record of the following types of surgery: salvage surgery for persistent or residual disease at the primary tumor site requiring surgical removal when invasive cancer is present on final pathology; neck dissection or surgery (performed for clinical or radiological disease progression per RECIST 1.1) ≤ 20 weeks from end of CRT when invasive cancer is present; or neck dissection or surgery \>20 weeks from end of CRT when invasive cancer is present. The non-parametric Kaplan-Meier method was used to estimate the EFS curve in each treatment group.
Up to approximately 62 months
Secondary Outcomes (8)
Overall Survival (OS)
Up to approximately 62 months
Number of Participants Who Experienced an Adverse Event (AE)
Up to approximately 88 months
Number of Participants Who Discontinued Study Drug Due to an AE
Up to approximately 15 months
Change From Baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score
Baseline and up to week 45
Change From Baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Questionnaire (EORTC QLQ-H&N35) Swallowing Score
Baseline and up to Week 45
- +3 more secondary outcomes
Study Arms (2)
Pembrolizumab + Cisplatin + CRT
EXPERIMENTALParticipants receive a priming dose of pembrolizumab before initiation of CRT (either accelerated or standard fractionation radiotherapy regimen). During CRT, participants receive 2 doses of pembrolizumab and up to 3 cycles of Cisplatin (2 cycles during accelerated and 3 cycles during standard fractionation radiotherapy). Participants also receive up to an additional 14 cycles of pembrolizumab alone as maintenance therapy for a total of 17 cycles of pembrolizumab. If cisplatin and/or radiation therapy is discontinued, the participant may continue on treatment with pembrolizumab.
Placebo + Cisplatin + CRT
PLACEBO COMPARATORParticipants receive placebo before initiation of CRT (either accelerated or standard fractionation radiotherapy regimen). During CRT, participants receive 2 doses of placebo and up to 3 cycles of Cisplatin (2 cycles during accelerated and 3 cycles during standard fractionation radiotherapy). Participants also receive up to an additional 14 cycles of placebo alone for a total of 17 cycles of placebo. If cisplatin and/or radiation therapy is discontinued, the participant may continue on treatment with placebo.
Interventions
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Normal saline or dextrose solution administered as an IV infusion Q3W
100 mg/m\^2 administered as an IV infusion Q3W
70 Gray (Gy) given in 35 fractions over 6 weeks
70 Gy given in 35 fractions over 7 weeks
Eligibility Criteria
You may qualify if:
- Has a pathologically proven new diagnosis of oropharyngeal p16 positive, oropharyngeal p16 negative, or larynx/hypopharynx/oral cavity (independent of p16) squamous cell carcinoma. Participants with oral cavity tumors need to have unresectable disease. Participants with multiple synchronous tumors are not eligible for the study.
- Has provided tissue for Programmed Cell Death Receptor Ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy. If an excisional or incisional biopsy has been performed, participants remain eligible for the study provided the residual disease meets the staging criteria required for the trial (e.g., excisional biopsy of a lymph node with residual T4 primary). Prior surgical debulking, including tonsillectomy, for the head and neck cancer under study is not allowed.
- Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging, based on RECIST version 1.1
- Is eligible for definitive CRT and not considered for primary surgery based on investigator decision
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days prior to receiving the first dose of study therapy
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
- 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
You may not qualify if:
- Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy
- Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-PD-L1, anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in clinical studies with pembrolizumab
- Has received a live vaccine within 30 days prior to the first dose of study therapy
- 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
- Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study
- Has not recovered from major surgery prior to starting study therapy
- Has known active Hepatitis B or C
- Has known history of Human Immunodeficiency Virus (HIV)
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
- Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has had previous allogeneic tissue/solid organ transplant
- Has active infection requiring systemic therapy
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (151)
UCLA Medical Center ( Site 0273)
Los Angeles, California, 90095, United States
University of California San Francisco ( Site 0274)
San Francisco, California, 94115, United States
St. Joseph Heritage Healthcare ( Site 0254)
Santa Rosa, California, 95403, United States
Smilow Cancer Hospital at Yale New Haven ( Site 0256)
New Haven, Connecticut, 06510, United States
Rush University Medical Center ( Site 0260)
Chicago, Illinois, 60612, United States
Indiana University ( Site 0264)
Indianapolis, Indiana, 46202, United States
Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281)
Baton Rouge, Louisiana, 70809, United States
University of Massachusetts Memorial Medical Center ( Site 0285)
Worcester, Massachusetts, 01655, United States
University of Michigan Hospital and Health Systems ( Site 0267)
Ann Arbor, Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute ( Site 0272)
Detroit, Michigan, 48201, United States
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290)
Springfield, Missouri, 65804, United States
St. Vincent Healthcare Frontier Cancer Center ( Site 0286)
Billings, Montana, 59102, United States
Comprehensive Cancer Centers of Nevada ( Site 8004)
Las Vegas, Nevada, 89169, United States
University of Rochester - James P. Wilmot Cancer Center ( Site 0255)
Rochester, New York, 14642, United States
Oncology Hematology Care, Inc. ( Site 8003)
Cincinnati, Ohio, 45242, United States
Willamette Valley Cancer Institute and Research Center ( Site 8000)
Eugene, Oregon, 97401, United States
St. Luke's Cancer Center - Anderson ( Site 0251)
Easton, Pennsylvania, 18045, United States
St. Francis Hospital Cancer Center ( Site 1461)
Greenville, South Carolina, 29607, United States
Texas Oncology-Arlington North ( Site 8005)
Arlington, Texas, 76014, United States
Texas Oncology-Austin Central ( Site 8002)
Austin, Texas, 78731, United States
Texas Oncology PA ( Site 8001)
Longview, Texas, 75601, United States
University of Virginia Health System ( Site 0261)
Charlottesville, Virginia, 22908, United States
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269)
Seattle, Washington, 98109, United States
Medical Oncology Associates (Summit Cancer Centers) ( Site 0257)
Spokane, Washington, 99208, United States
Blacktown Hospital Western Sydney Local Health District ( Site 0304)
Blacktown, New South Wales, 2148, Australia
Liverpool Hospital ( Site 0301)
Liverpool, New South Wales (Australia), 2170, Australia
Princess Alexandra Hospital ( Site 0305)
Brisbane, Queensland, 4102, Australia
Royal Brisbane and Women s Hospital ( Site 0302)
Herston, Queensland, 4029, Australia
Royal Adelaide Hospital ( Site 0303)
Adelaide, South Australia, 5000, Australia
Peter MacCallum Cancer Centre ( Site 0300)
Melbourne, Victoria, 3000, Australia
Landeskrankenhaus - Universitatsklinikum Graz ( Site 0601)
Graz, 8036, Austria
Krankenhaus der Barmherzigen Schwestern Linz ( Site 0603)
Linz, 4010, Austria
Landeskrankenhaus Salzburg ( Site 0600)
Salzburg, 5020, Austria
Allgemeines Krankenhaus der Stadt Wien ( Site 0602)
Vienna/Wien, 1090, Austria
Cliniques Universitaires Saint Luc - Bruxelles ( Site 0651)
Brussels, 1200, Belgium
UZ Gent ( Site 0650)
Ghent, 9000, Belgium
UZ Leuven Campus Gasthuisberg ( Site 0652)
Leuven, 3000, Belgium
C.H.U. Sart Tilman-Service d'Oncologie Medicale ( Site 0654)
Liège, 4000, Belgium
Clinique et Maternite Sainte-Elisabeth ( Site 0653)
Namur, 5000, Belgium
Centro Regional Integrado de Oncologia ( Site 0002)
Fortaleza, Ceará, 60336-045, Brazil
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0006)
Salvador, Estado de Bahia, 40050-410, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 0005)
Natal, Rio Grande do Norte, 59075-740, Brazil
Hospital de Clinicas de Porto Alegre ( Site 0011)
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0001)
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0003)
Barretos, São Paulo, 14784-400, Brazil
Instituto do Cancer de Sao Paulo - ICESP ( Site 0004)
São Paulo, São Paulo, 01246-000, Brazil
Hospital das Clinicas da FMUSP de Ribeirao Preto ( Site 0008)
Ribeirão Preto, 14048-900, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0010)
Rio de Janeiro, 20230-130, Brazil
Tom Baker Cancer Centre ( Site 0063)
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute ( Site 0064)
Edmonton, Alberta, T6G 1Z2, Canada
Juravinski Cancer Centre ( Site 0062)
Hamilton, Ontario, L8V 5C2, Canada
London Health Sciences Centre ( Site 0055)
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital - Cancer Care ( Site 0052)
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre ( Site 0051)
Toronto, Ontario, M5G 1X5, Canada
McGill University Health Centre ( Site 0061)
Montreal, Quebec, H4A 3J1, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0057)
Sherbrooke, Quebec, J1H 5N4, Canada
Hospital Pablo Tobon Uribe ( Site 0151)
Medellín, Antioquia, 050034, Colombia
Fundacion Valle del Lili ( Site 0150)
Cali, Valle del Cauca Department, 760032, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0156)
Cali, Valle del Cauca Department, 760042, Colombia
Centro de Investigacion Clinica del Country ( Site 0155)
Bogotá, 110221, Colombia
FN Brno. ( Site 0703)
Brno, 625 00, Czechia
Fakultni Nemocnice Hradec Kralove ( Site 0705)
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc ( Site 0701)
Olomouc, 775 20, Czechia
Fakultni nemocnice Ostrava ( Site 0702)
Ostrava, 708 52, Czechia
2. LF UK a FN Motol ( Site 0704)
Prague, 150 06, Czechia
Nemocnice Na Bulovce ( Site 0700)
Prague, 180 81, Czechia
Centre Jean Bernard Laboratoire Mahe Meziani ( Site 0760)
Le Mans, 72000, France
Clinique Francois Chenieux ( Site 0757)
Limoges, 87039, France
Institut Claudius Regaud ( Site 0754)
Toulouse, 31059, France
Institut De Cancerologie De Lorraine ( Site 0758)
Vandœuvre-lès-Nancy, 54500, France
Institut Gustave Roussy ( Site 0759)
Villejuif, 94805, France
Universitätsklinikum Erlangen ( Site 0801)
Erlangen, 91054, Germany
SRH Waldklinikum Gera GmbH ( Site 0802)
Gera, 07548, Germany
Universitares Cancer Center Hamburg - UCCH ( Site 0811)
Hamburg, 20246, Germany
Medizinische Hochschule Hannover ( Site 0807)
Hanover, 30325, Germany
Universitaetsklinikum Schleswig-Holstein-Campus Luebeck ( Site 0803)
Lübeck, 23538, Germany
Klinikum der Universitaet Munchen ( Site 0810)
München, 81377, Germany
Universitaetsklinik Ulm ( Site 0804)
Ulm, 89075, Germany
Rambam MC ( Site 0903)
Haifa, 3109601, Israel
Hadassah Ein Karem Jerusalem ( Site 0902)
Jerusalem, 9112001, Israel
Rabin Medical Center ( Site 0904)
Petah Tikva, 4941492, Israel
Sheba MC ( Site 0901)
Ramat Gan, 5265601, Israel
Tel Aviv Sourasky Medical Center ( Site 0900)
Tel Aviv, 6423906, Israel
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0954)
Modena, MO, 41124, Italy
Azienda Ospedaliero Universitaria Careggi ( Site 0955)
Florence, 50134, Italy
Istituto Nazionale Tumori ( Site 0950)
Milan, 20133, Italy
Istituto Europeo di Oncologia ( Site 0953)
Milan, 20141, Italy
Azienda Ospedaliera San Paolo ( Site 0952)
Milan, 20142, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0951)
Naples, 80121, Italy
Istituto Oncologico Veneto ( Site 0957)
Padua, 35128, Italy
Fondazione IRCCS - Policlinico San Matteo ( Site 0960)
Pavia, 27100, Italy
National Cancer Center Hospital East ( Site 0350)
Kashiwa, Chiba, 277-8577, Japan
Hokkaido University Hospital ( Site 0351)
Sapporo, Hokkaido, 060-8648, Japan
Hyogo Cancer Center ( Site 0354)
Akashi, Hyōgo, 673-8558, Japan
Kagawa University Hospital ( Site 0359)
Kita-gun, Kagawa-ken, 761-0793, Japan
Miyagi Cancer Center ( Site 0353)
Natori-shi, Miyagi, 981-1293, Japan
Chiba Cancer Center ( Site 0358)
Chiba, 260-8717, Japan
Hiroshima University Hospital ( Site 0352)
Hiroshima, 734-8551, Japan
Osaka International Cancer Institute ( Site 0355)
Osaka, 541-8567, Japan
Medical Hospital, Tokyo Medical And Dental University ( Site 0356)
Tokyo, 113-8519, Japan
The Cancer Institute Hospital of JFCR ( Site 0357)
Tokyo, 135-8550, Japan
Noordwest Ziekenhuisgroep NWZ ( Site 1350)
Alkmaar, 1815 JD, Netherlands
VU Medisch Centrum ( Site 1352)
Amsterdam, 1081 HV, Netherlands
UMCG ( Site 1351)
Groningen, 9713 GZ, Netherlands
UMC St. Radboud ( Site 1356)
Nijmegen, 6525 GA, Netherlands
Erasmus University Medical Center ( Site 1354)
Rotterdam, 3015 GD, Netherlands
Capital & Coast District Health Board - Wellington Hospital ( Site 0400)
Wellington, Newtown, 6021, New Zealand
Dolnoslaskie Centrum Onkologii. ( Site 1001)
Wroclaw, Lower Silesian Voivodeship, 53-413, Poland
Mazowiecki Szpital Onkologiczny ( Site 1015)
Wieliszew, Masovian Voivodeship, 05-135, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1005)
Bielsko-Biala, 43-300, Poland
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007)
Gdynia, 81-519, Poland
Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 1010)
Gliwice, 44-101, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1008)
Krakow, 31-826, Poland
Zachodniopomorskie Centrum Onkologii ( Site 1013)
Szczecin, 71-730, Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000)
Warsaw, 02-781, Poland
Seoul National University Bundang Hospital ( Site 0453)
Seongnam-si, Gyeonggi-do, 13620, South Korea
Chungbuk National University Hospital ( Site 0454)
Cheongju-si, North Chungcheong, 28644, South Korea
Chungnam National University Hospital ( Site 0455)
Daejeon, 35015, South Korea
Severance Hospital Yonsei University Health System ( Site 0452)
Seoul, 03722, South Korea
Samsung Medical Center ( Site 0450)
Seoul, 06351, South Korea
H.U. Vall de Hebron ( Site 1052)
Barcelona, 08035, Spain
Hospital Duran i Reynals ( Site 1053)
L'Hospitalet de Llobregat, 08907, Spain
Hospital Doce de Octubre ( Site 1054)
Madrid, 28024, Spain
Hospital Universitario Ramon y Cajal ( Site 1055)
Madrid, 28034, Spain
Hospital Clinico San Carlos ( Site 1051)
Madrid, 28040, Spain
Hospital Universitario Virgen de la Victoria ( Site 1056)
Málaga, 29010, Spain
Hospital Gral Universitario de Valencia ( Site 1050)
Valencia, 46014, Spain
Chang Gung Medical Foundation - Kaohsiung ( Site 0501)
Kaohsiung City, 83301, Taiwan
Taichung Veterans General Hospital ( Site 0506)
Taichung, 407, Taiwan
National Cheng Kung University Hospital ( Site 0503)
Tainan, 70403, Taiwan
National Taiwan University Hospital ( Site 0500)
Taipei, 10048, Taiwan
MacKay Memorial Hospital ( Site 0505)
Taipei, 105, Taiwan
Taipei Veterans General Hospital ( Site 0504)
Taipei, 112, Taiwan
Linkou Chang Gung Memorial Hospital ( Site 0502)
Taoyuan District, 333, Taiwan
Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1103)
Adana, 01250, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1102)
Ankara, 06100, Turkey (Türkiye)
Ankara Sehir Hastanesi ( Site 1108)
Ankara, 06800, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1100)
Istanbul, 34093, Turkey (Türkiye)
Medipol Universite Hastanesi ( Site 1104)
Istanbul, 34214, Turkey (Türkiye)
Medical Park Izmir Hastanesi ( Site 1109)
Izmir, 35520, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi ( Site 1106)
Kocaeli, 41380, Turkey (Türkiye)
Inonu Universitesi Tip Fakultesi ( Site 1101)
Malatya, 44280, Turkey (Türkiye)
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1206)
Norwich, Norfolk, NR4 7UY, United Kingdom
University Hospital of North Staffordshire ( Site 1202)
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Ipswich Hospital ( Site 1207)
Ipswich, Suffolk, IP4 5PD, United Kingdom
St Bartholomew s Hospital ( Site 1205)
London, EC1A 7BE, United Kingdom
The Royal Marsden Foundation Trust ( Site 1200)
London, SW3 6JJ, United Kingdom
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1204)
London, W6 8RF, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1208)
Preston, PR2 9HT, United Kingdom
University Hospital Southampton NHS Foundation Trust ( Site 1203)
Southampton, SO16 6YD, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 1201)
Sutton, SM2 5PT, United Kingdom
Related Publications (2)
Machiels JP, Tao Y, Licitra L, Burtness B, Tahara M, Rischin D, Alves G, Lima IPF, Hughes BGM, Pointreau Y, Aksoy S, Laban S, Greil R, Burian M, Hetnal M, Delord JP, Mesia R, Taberna M, Waldron JN, Simon C, Gregoire V, Harrington KJ, Swaby RF, Zhang Y, Gumuscu B, Bidadi B, Siu LL; KEYNOTE-412 Investigators. Pembrolizumab plus concurrent chemoradiotherapy versus placebo plus concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (KEYNOTE-412): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2024 May;25(5):572-587. doi: 10.1016/S1470-2045(24)00100-1. Epub 2024 Mar 29.
PMID: 38561010DERIVEDMachiels JP, Tao Y, Burtness B, Tahara M, Licitra L, Rischin D, Waldron J, Simon C, Gregoire V, Harrington K, Alves GV, Figueiredo Lima IP, Pointreau Y, M Hughes BG, Aksoy S, Hetnal M, Ge JY, Brown H, Cheng J, Bidadi B, Siu LL. Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. Future Oncol. 2020 Jun;16(18):1235-1243. doi: 10.2217/fon-2020-0184. Epub 2020 Jun 3.
PMID: 32490686DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2017
First Posted
February 2, 2017
Study Start
April 5, 2017
Primary Completion
May 31, 2022
Study Completion
August 21, 2024
Last Updated
February 4, 2026
Results First Posted
June 8, 2023
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf