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)

PHASE3CompletedINTERVENTIONAL
Enrollment

804

Participants

Timeline

Start Date

April 5, 2017

Primary Completion Date

May 31, 2022

Study Completion Date

August 21, 2024

Conditions
Head and Neck Neoplasms
Interventions
BIOLOGICAL

Pembrolizumab

Administered as an intravenous (IV) infusion every 3 weeks (Q3W)

DRUG

Placebo

Normal saline or dextrose solution administered as an IV infusion Q3W

DRUG

Cisplatin

100 mg/m\^2 administered as an IV infusion Q3W

RADIATION

Accelerated Fractionation (AFX) Radiotherapy

70 Gray (Gy) given in 35 fractions over 6 weeks

RADIATION

Standard Fractionation (SFX) Radiotherapy

70 Gy given in 35 fractions over 7 weeks

Trial Locations (151)

105

MacKay Memorial Hospital ( Site 0505), Taipei

112

Taipei Veterans General Hospital ( Site 0504), Taipei

333

Linkou Chang Gung Memorial Hospital ( Site 0502), Taoyuan District

407

Taichung Veterans General Hospital ( Site 0506), Taichung

1090

Allgemeines Krankenhaus der Stadt Wien ( Site 0602), Vienna/Wien

1200

Cliniques Universitaires Saint Luc - Bruxelles ( Site 0651), Brussels

2148

Blacktown Hospital Western Sydney Local Health District ( Site 0304), Blacktown

2170

Liverpool Hospital ( Site 0301), Liverpool

3000

Peter MacCallum Cancer Centre ( Site 0300), Melbourne

UZ Leuven Campus Gasthuisberg ( Site 0652), Leuven

4000

C.H.U. Sart Tilman-Service d'Oncologie Medicale ( Site 0654), Liège

4010

Krankenhaus der Barmherzigen Schwestern Linz ( Site 0603), Linz

4029

Royal Brisbane and Women s Hospital ( Site 0302), Herston

4102

Princess Alexandra Hospital ( Site 0305), Brisbane

5000

Royal Adelaide Hospital ( Site 0303), Adelaide

Clinique et Maternite Sainte-Elisabeth ( Site 0653), Namur

5020

Landeskrankenhaus Salzburg ( Site 0600), Salzburg

6021

Capital & Coast District Health Board - Wellington Hospital ( Site 0400), Wellington

8036

Landeskrankenhaus - Universitatsklinikum Graz ( Site 0601), Graz

9000

UZ Gent ( Site 0650), Ghent

10048

National Taiwan University Hospital ( Site 0500), Taipei

13620

Seoul National University Bundang Hospital ( Site 0453), Seongnam-si

14642

University of Rochester - James P. Wilmot Cancer Center ( Site 0255), Rochester

18045

St. Luke's Cancer Center - Anderson ( Site 0251), Easton

20133

Istituto Nazionale Tumori ( Site 0950), Milan

20141

Istituto Europeo di Oncologia ( Site 0953), Milan

20142

Azienda Ospedaliera San Paolo ( Site 0952), Milan

20246

Universitares Cancer Center Hamburg - UCCH ( Site 0811), Hamburg

22908

University of Virginia Health System ( Site 0261), Charlottesville

23538

Universitaetsklinikum Schleswig-Holstein-Campus Luebeck ( Site 0803), Lübeck

27100

Fondazione IRCCS - Policlinico San Matteo ( Site 0960), Pavia

28024

Hospital Doce de Octubre ( Site 1054), Madrid

28034

Hospital Universitario Ramon y Cajal ( Site 1055), Madrid

28040

Hospital Clinico San Carlos ( Site 1051), Madrid

28644

Chungbuk National University Hospital ( Site 0454), Cheongju-si

29010

Hospital Universitario Virgen de la Victoria ( Site 1056), Málaga

29607

St. Francis Hospital Cancer Center ( Site 1461), Greenville

30325

Medizinische Hochschule Hannover ( Site 0807), Hanover

31059

Institut Claudius Regaud ( Site 0754), Toulouse

34093

Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1100), Istanbul

34214

Medipol Universite Hastanesi ( Site 1104), Istanbul

35015

Chungnam National University Hospital ( Site 0455), Daejeon

35128

Istituto Oncologico Veneto ( Site 0957), Padua

35520

Medical Park Izmir Hastanesi ( Site 1109), Izmir

41124

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0954), Modena

41380

Kocaeli Universitesi Tip Fakultesi ( Site 1106), Kocaeli

44280

Inonu Universitesi Tip Fakultesi ( Site 1101), Malatya

45242

Oncology Hematology Care, Inc. ( Site 8003), Cincinnati

46014

Hospital Gral Universitario de Valencia ( Site 1050), Valencia

46202

Indiana University ( Site 0264), Indianapolis

48109

University of Michigan Hospital and Health Systems ( Site 0267), Ann Arbor

48201

Barbara Ann Karmanos Cancer Institute ( Site 0272), Detroit

50134

Azienda Ospedaliero Universitaria Careggi ( Site 0955), Florence

54500

Institut De Cancerologie De Lorraine ( Site 0758), Vandœuvre-lès-Nancy

59102

St. Vincent Healthcare Frontier Cancer Center ( Site 0286), Billings

60612

Rush University Medical Center ( Site 0260), Chicago

65804

Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290), Springfield

70403

National Cheng Kung University Hospital ( Site 0503), Tainan City

70809

Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281), Baton Rouge

72000

Centre Jean Bernard Laboratoire Mahe Meziani ( Site 0760), Le Mans

75601

Texas Oncology PA ( Site 8001), Longview

76014

Texas Oncology-Arlington North ( Site 8005), Arlington

78731

Texas Oncology-Austin Central ( Site 8002), Austin

80121

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0951), Napoli

81377

Klinikum der Universitaet Munchen ( Site 0810), München

83301

Chang Gung Medical Foundation - Kaohsiung ( Site 0501), Kaohsiung City

87039

Clinique Francois Chenieux ( Site 0757), Limoges

89075

Universitaetsklinik Ulm ( Site 0804), Ulm

89169

Comprehensive Cancer Centers of Nevada ( Site 8004), Las Vegas

90095

UCLA Medical Center ( Site 0273), Los Angeles

91054

Universitätsklinikum Erlangen ( Site 0801), Erlangen

94115

University of California San Francisco ( Site 0274), San Francisco

94805

Institut Gustave Roussy ( Site 0759), Villejuif

95403

St. Joseph Heritage Healthcare ( Site 0254), Santa Rosa

97401

Willamette Valley Cancer Institute and Research Center ( Site 8000), Eugene

98109

Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269), Seattle

99208

Medical Oncology Associates (Summit Cancer Centers) ( Site 0257), Spokane

110221

Centro de Investigacion Clinica del Country ( Site 0155), Bogotá

760032

Fundacion Valle del Lili ( Site 0150), Santiago de Cali

760042

Centro Medico Imbanaco de Cali S.A ( Site 0156), Santiago de Cali

3109601

Rambam MC ( Site 0903), Haifa

4941492

Rabin Medical Center ( Site 0904), Petah Tikva

5265601

Sheba MC ( Site 0901), Ramat Gan

6423906

Tel Aviv Sourasky Medical Center ( Site 0900), Tel Aviv

9112001

Hadassah Ein Karem Jerusalem ( Site 0902), Jerusalem

06510

Smilow Cancer Hospital at Yale New Haven ( Site 0256), New Haven

01655

University of Massachusetts Memorial Medical Center ( Site 0285), Worcester

60336-045

Centro Regional Integrado de Oncologia ( Site 0002), Fortaleza

40050-410

Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0006), Salvador

59075-740

Liga Norte Riograndense Contra o Cancer ( Site 0005), Natal

90035-903

Hospital de Clinicas de Porto Alegre ( Site 0011), Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao ( Site 0001), Porto Alegre

14784-400

Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0003), Barretos

01246-000

Instituto do Cancer de Sao Paulo - ICESP ( Site 0004), São Paulo

14048-900

Hospital das Clinicas da FMUSP de Ribeirao Preto ( Site 0008), Ribeirão Preto

20230-130

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0010), Rio de Janeiro

T2N 4N2

Tom Baker Cancer Centre ( Site 0063), Calgary

T6G 1Z2

Cross Cancer Institute ( Site 0064), Edmonton

L8V 5C2

Juravinski Cancer Centre ( Site 0062), Hamilton

N6A 4L6

London Health Sciences Centre ( Site 0055), London

K1H 8L6

The Ottawa Hospital - Cancer Care ( Site 0052), Ottawa

M5G 1X5

Princess Margaret Cancer Centre ( Site 0051), Toronto

H4A 3J1

McGill University Health Centre ( Site 0061), Montreal

J1H 5N4

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0057), Sherbrooke

050034

Hospital Pablo Tobon Uribe ( Site 0151), Medellín

625 00

FN Brno. ( Site 0703), Brno

500 05

Fakultni Nemocnice Hradec Kralove ( Site 0705), Hradec Králové

775 20

Fakultni nemocnice Olomouc ( Site 0701), Olomouc

708 52

Fakultni nemocnice Ostrava ( Site 0702), Ostrava

150 06

2. LF UK a FN Motol ( Site 0704), Prague

180 81

Nemocnice Na Bulovce ( Site 0700), Prague

07548

SRH Waldklinikum Gera GmbH ( Site 0802), Gera

277-8577

National Cancer Center Hospital East ( Site 0350), Kashiwa

060-8648

Hokkaido University Hospital ( Site 0351), Sapporo

673-8558

Hyogo Cancer Center ( Site 0354), Akashi

761-0793

Kagawa University Hospital ( Site 0359), Kita-gun

981-1293

Miyagi Cancer Center ( Site 0353), Natori-shi

260-8717

Chiba Cancer Center ( Site 0358), Chiba

734-8551

Hiroshima University Hospital ( Site 0352), Hiroshima

541-8567

Osaka International Cancer Institute ( Site 0355), Osaka

113-8519

Medical Hospital, Tokyo Medical And Dental University ( Site 0356), Tokyo

135-8550

The Cancer Institute Hospital of JFCR ( Site 0357), Tokyo

1815 JD

Noordwest Ziekenhuisgroep NWZ ( Site 1350), Alkmaar

1081 HV

VU Medisch Centrum ( Site 1352), Amsterdam

9713 GZ

UMCG ( Site 1351), Groningen

6525 GA

UMC St. Radboud ( Site 1356), Nijmegen

3015 GD

Erasmus University Medical Center ( Site 1354), Rotterdam

53-413

Dolnoslaskie Centrum Onkologii. ( Site 1001), Wroclaw

05-135

Mazowiecki Szpital Onkologiczny ( Site 1015), Wieliszew

43-300

Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1005), Bielsko-Biala

81-519

Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007), Gdynia

44-101

Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 1010), Gliwice

31-826

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1008), Krakow

71-730

Zachodniopomorskie Centrum Onkologii ( Site 1013), Szczecin

02-781

Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000), Warsaw

03722

Severance Hospital Yonsei University Health System ( Site 0452), Seoul

06351

Samsung Medical Center ( Site 0450), Seoul

08035

H.U. Vall de Hebron ( Site 1052), Barcelona

08907

Hospital Duran i Reynals ( Site 1053), L'Hospitalet de Llobregat

01250

Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1103), Adana

06100

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1102), Ankara

06800

Ankara Sehir Hastanesi ( Site 1108), Ankara

NR4 7UY

Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1206), Norwich

ST4 6QG

University Hospital of North Staffordshire ( Site 1202), Stoke-on-Trent

IP4 5PD

Ipswich Hospital ( Site 1207), Ipswich

EC1A 7BE

St Bartholomew s Hospital ( Site 1205), London

SW3 6JJ

The Royal Marsden Foundation Trust ( Site 1200), London

W6 8RF

Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1204), London

PR2 9HT

Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1208), Preston

SO16 6YD

University Hospital Southampton NHS Foundation Trust ( Site 1203), Southampton

SM2 5PT

Royal Marsden NHS Foundation Trust ( Site 1201), Sutton

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03040999 - 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) | Biotech Hunter | Biotech Hunter