749
Participants
Start Date
July 25, 2017
Primary Completion Date
July 2, 2020
Study Completion Date
July 10, 2023
Pembrolizumab
200 mg administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.
Placebo
Placebo to pembrolizumab (saline) administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.
Cisplatin
80 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle. Duration of cisplatin treatment will be capped at 6 doses.
5-FU
800 mg/m\^2/day (4000 mg/m\^2 total per cycle) administered as continuous IV infusion on Days 1 to 5 (120 hours) of each 3-week cycle, or per local standard for 5-FU administration, up to 35 administrations.
Taipei Medical University Shuang Ho Hospital ( Site 1908), New Taipei City
Chang Gung Medical Foundation. Linkou ( Site 1903), Taoyuan District
China Medical University Hospital ( Site 1904), Taichung
National Cheng Kung University Hospital ( Site 1905), Tainan City
Chi Mei Medical Center Liuying ( Site 1907), Tainan City
Chang Gung Med Foundation. Kaohsiung Branch ( Site 1906), Kaohsiung City
Clinton Oncology Centre ( Site 2505), Alberton
Rigshospitalet ( Site 2301), Copenhagen
Blacktown Hospital ( Site 2000), Blacktown
Liverpool Hospital. ( Site 2001), Liverpool
WITS Clinical Research CMJAH Clinical Trial Site ( Site 2500), Parktown
The Medical Oncology Centre of Rosebank ( Site 2506), Johannesburg
Peter MacCallum Cancer Centre ( Site 2003), Melbourne
Eastern Health ( Site 2002), Box Hill
The Oncology Centre ( Site 2502), Durban
Princess Alexandra Hospital ( Site 2005), Woolloongabba
Odense Universitetshospital ( Site 2300), Odense
Cancer Care Langenhoven Drive Oncology Centre ( Site 2501), Port Elizabeth
Outeniqua Cancercare Oncology Unit ( Site 2504), George
Cape Town Oncology Trials Pty Ltd ( Site 2508), Cape Town
National Taiwan University Hospital ( Site 1900), Taipei
Weill Cornell Medical College ( Site 0024), New York
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 2600), San José
Policlinico San Bosco ( Site 2602), San José
ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 2601), San José
Bumrungrad International Hospital ( Site 2203), Bangkok
Chulalongkorn Hospital ( Site 2201), Bangkok
Ramathibodi Hospital. ( Site 2202), Bangkok
Phramongkutklao Hospital ( Site 2205), Bangkok
National Cancer Center ( Site 1304), Goyang-si
Koo Foundation Sun Yat-Sen Cancer Center ( Site 1902), Taipei
Hospital Universitario Reina Sofia ( Site 0706), Córdoba
Centre Francois Baclesse ( Site 0310), Caen
Roswell Park Cancer Institute ( Site 0004), Buffalo
Hospital Nacional Guillermo Almenara Irigoyen ( Site 1701), Lima
Instituto Nacional de Enfermedades Neoplasicas ( Site 1705), Lima
UPMC Cancer Center/Hillman Cancer Center ( Site 0015), Pittsburgh
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1502), Hamburg
University of Maryland Medical Center ( Site 0013), Baltimore
Hospital Ramon y Cajal ( Site 0703), Madrid
Hospital Universitario La Paz ( Site 0700), Madrid
Complejo Hospitalario Virgen De La Victoria ( Site 0705), Málaga
CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0305), Brest
Hospital Universitario Central de Asturias ( Site 0708), Oviedo
Istanbul Medeniyet Universitesi Goztepe EAH ( Site 0807), Istanbul
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0804), Istanbul
Institut du Cancer de Montpellier ( Site 0306), Montpellier
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0801), Istanbul
Medical Park Izmir Hastanesi ( Site 0800), Izmir
University of Tennessee Medical Center Knoxville ( Site 0017), Knoxville
Klinik fuer Haematologie. Onkologie und Gastroenterologie ( Site 1508), Mönchengladbach
CHU de Saint Etienne Hopital Nord ( Site 0309), Saint-Etienne
Kuang Tien General Hospital ( Site 1909), Taichung
CHU de Nantes - Hotel Dieu ( Site 0303), Nantes
University Hospitals Cleveland Medical Center ( Site 0002), Cleveland
Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 0803), Malatya
Beacon International Specialist Centre ( Site 1803), Petaling Jaya
Henry Ford Cancer Center ( Site 0018), Detroit
Hospital Kuala Lumpur ( Site 1805), Kuala Lumpur
Chonnam National University Hwasun Hospital ( Site 1305), Hwasun Gun
Centre Oscar Lambret ( Site 0304), Lille
University Malaya Medical Centre ( Site 1802), Kuala Lumpur
The University of Chicago Medical Center ( Site 0001), Chicago
Washington University School of Medicine ( Site 0031), St Louis
University of Kansas ( Site 0029), Westwood
Universitatsklinikum Mannheim GmbH ( Site 1504), Mannheim
Centre Leon Berard ( Site 0307), Lyon
Klinikum Ludwigsburg ( Site 1509), Ludwigsburg
Institut Mutualiste Montsouris ( Site 0300), Paris
III. Medizinische Klinik Klinikum rechts der Isar ( Site 1506), München
Kaiser Permanente Southern California ( Site 0003), West Los Angeles
Songklanagarind Hospital ( Site 2204), Songkhla
Peking Union Medical College Hospital ( Site 0123), Beijing
Beijing Cancer Hospital ( Site 0100), Beijing
National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0402), Moscow
N.N. Blokhin NMRCO ( Site 0401), Moscow
Jilin Cancer Hospital ( Site 0101), Changchun
The Affiliated Tumour Hospital of Harbin Medical University ( Site 0102), Harbin
Leningrad Regional Oncology Center ( Site 0405), Saint Petersburg
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0406), Saint Petersburg
St Petersburg City Clinical Oncology Dispensary ( Site 0409), Saint Petersburg
Shanghai Chest Hospital ( Site 0111), Shanghai
Fudan University Shanghai Cancer Center ( Site 0108), Shanghai
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0114), Shanghai
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2404), Craiova
PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0110), Nanjing
Zhongda Hospital Southeast University ( Site 0125), Nanjing
Oncomedica S.A. ( Site 2701), Montería
Anhui Provincial Hospital ( Site 0106), Hefei
The First Affiliated Hospital of Anhui Medical University ( Site 0112), Hefei
S C Oncocenter Oncologie Medicala S R L ( Site 2405), Timișoara
Zhejiang Cancer Hospital ( Site 0116), Hangzhou
Fujian Provincial Cancer Hospital ( Site 0104), Fuzhou
The First Affiliated Hospital of Xiamen University ( Site 0119), Xiamen
S.C. Radiotherapy Center Cluj S.R.L ( Site 2407), Comuna Floresti
Hunan Cancer Hospital ( Site 0105), Changsha
S C Pelican Impex SRL ( Site 2403), Oradea
Tongji Medical College Huazhong University of Science and Technology ( Site 0109), Wuhan
Henan Cancer Hospital ( Site 0107), Zhengzhou
SBHCI RCOD of MHC RB ( Site 0407), Ufa
Guangdong General Hospital ( Site 0103), Guangzhou
Tomsk Scientific Research Institute of Oncology ( Site 0403), Tomsk
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0120), Xi'an
Spitalul Clinic Judetean De Urgenta Constanta ( Site 2402), Constanța
Hospital Regional de Concepcion Dr. Guillermo Grant Benavente ( Site 1003), Concepción
Clinica Alemana de Temuco ( Site 1006), Temuco
Pontificia Universidad Catolica de Chile ( Site 1001), Santiago
Hospital Clinico Universidad de Chile ( Site 1002), Santiago
Dana Farber Cancer Center ( Site 0009), Boston
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0603), Viedma
Hospital Aleman ( Site 0605), Buenos Aires
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0602), Buenos Aires
Sanatorio Allende - Cordoba ( Site 0604), Córdoba
Hospital Privado Centro Medico Cordoba ( Site 0601), Córdoba
CETUS Hospital Dia Oncologia ( Site 0208), Belo Horizonte
Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0210), Recife
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0209), Rio de Janeiro
Hospital Sao Vicente de Paulo ( Site 0204), Passo Fundo
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0201), Porto Alegre
Clinica de Hematologia e Oncologia Viver Ltda ( Site 0211), Santa Maria
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto. ( Site 0203), São José do Rio Preto
Hospital Alemao Oswaldo Cruz ( Site 0207), São Paulo
Hospital de Clinicas de Porto Alegre ( Site 0200), Porto Alegre
Instituto do Cancer de Sao Paulo - ICESP ( Site 0206), São Paulo
Tom Baker Cancer Centre ( Site 0503), Calgary
Cross Cancer Institute ( Site 0502), Edmonton
CancerCare Manitoba ( Site 0500), Winnipeg
Juravinski Cancer Center ( Site 0508), Hamilton
The Ottawa Hospital - Cancer Care ( Site 0501), Ottawa
Princess Margaret Cancer Centre ( Site 0505), Toronto
CISSS de la Monteregie-Centre ( Site 0504), Greenfield Park
Jewish General Hospital ( Site 0507), Montreal
Rodrigo Botero SAS ( Site 2703), Medellín
Staedtisches Klinikum Dresden ( Site 1507), Dresden
Universitaetsklinikum Leipzig ( Site 1501), Leipzig
Centro de Investigacion Oncologica ( Site 1402), Guatemala City
Oncomedica ( Site 1400), Guatemala City
Grupo Medico Angeles ( Site 1401), Guatemala City
Medi-K Cayala ( Site 1404), Guatemala City
Centro Regional de Sub Especialidades Medicas SA ( Site 1403), Quetzaltenango
Humanity Health Research Centre ( Site 1603), Hong Kong
Pamela Youde Nethersole Eastern Hospital ( Site 1601), Hong Kong
Princess Margaret Hospital. ( Site 1602), Hong Kong
Queen Mary Hospital ( Site 1600), Hong Kong
Aichi Cancer Center Hospital ( Site 0902), Nagoya
National Cancer Center Hospital East ( Site 0908), Kashiwa
National Hospital Organization Shikoku Cancer Center ( Site 0901), Matsuyama
Hokkaido University Hospital ( Site 0916), Sapporo
Hyogo Cancer Center ( Site 0913), Akashi
Kobe City Medical Center General Hospital ( Site 0929), Kobe
Ibaraki Prefectural Central Hospital ( Site 0918), Kasama
University of Tsukuba Hospital ( Site 0910), Tsukuba
Kagawa University Hospital ( Site 0915), Kita-gun
St. Marianna University School of Medicine Hospital ( Site 0903), Kawasaki
Kanagawa Cancer Center ( Site 0921), Yokohama
Oita University Hospital ( Site 0930), Yufu
Kansai Medical University Hospital ( Site 0931), Hirakata
Kindai University Hospital ( Site 0917), Sayama
Osaka University Hospital ( Site 0911), Suita
Osaka Medical College Hospital ( Site 0925), Takatsuki
Saitama Cancer Center ( Site 0926), Kitaadachi-gun
Shizuoka Cancer Center Hospital and Research Institute ( Site 0914), Sunto-gun
Kyorin University Hospital ( Site 0905), Mitaka
Chiba University Hospital ( Site 0909), Chiba
Chiba Cancer Center ( Site 0900), Chiba
National Hospital Organization Kyushu Cancer Center ( Site 0906), Fukuoka
Kyushu University Hospital ( Site 0922), Fukuoka
Gifu University Hospital ( Site 0920), Gifu
Kumamoto University Hospital ( Site 0919), Kumamoto
Niigata Cancer Center Hospital ( Site 0924), Niigata
Osaka International Cancer Institute ( Site 0923), Osaka
Osaka General Medical Center ( Site 0912), Osaka
National Cancer Center Hospital ( Site 0907), Tokyo
The Cancer Institute Hospital of JFCR ( Site 0904), Tokyo
Keio University Hospital ( Site 0927), Tokyo
Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 1702), Arequipa
S.C.Focus Lab Plus S.R.L ( Site 2401), Bucharest
S.C.Gral Medical S.R.L ( Site 2406), Bucharest
Seoul National University Cancer Hospital ( Site 1301), Seoul
Severance Hospital Yonsei University Health System ( Site 1302), Seoul
Asan Medical Center ( Site 1303), Seoul
Samsung Medical Center ( Site 1300), Seoul
Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0701), Badalona
Hospital Universitari Vall d Hebron ( Site 0702), Barcelona
Adana Sehir Hastanesi ( Site 0802), Adana
Ankara Sehir Hastanesi ( Site 0808), Ankara
Lothian University Hospitals NHS Trust ( Site 1101), Edinburgh
St Luke's Cancer Centre ( Site 1102), Guildford
The Christie NHS Foundation Trust ( Site 1100), Manchester
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INDUSTRY