1,579
Participants
Start Date
November 8, 2018
Primary Completion Date
October 3, 2022
Study Completion Date
March 3, 2025
Pembrolizumab
Administered as an IV infusion on Day 1 Q3W
Cisplatin
Administered as an IV infusion on Day 1 Q3W
5-fluorouracil
Administered as a continuous IV infusion on Days 1-5 Q3W
oxaliplatin
Administered as an IV infusion on Day 1 Q3W
capecitabine
Administered orally BID on Days 1 to 14 Q3W
Placebo for Pembrolizumab
Administered as an IV infusion on Day 1 Q3W
Mackay Memorial Hospital ( Site 2903), Taipei
Auckland City Hospital ( Site 2700), Auckland
Semmelweis Egyetem.. ( Site 3305), Budapest
Orszagos Onkologiai Intezet ( Site 3303), Budapest
Hopitaux Universitaires de Geneve HUG ( Site 1907), Geneva
Rigshospitalet ( Site 3202), Copenhagen
Liverpool Hospital ( Site 2301), Liverpool
Wits Clinical Research ( Site 1707), Parktown-Johannesburg
Sandton Oncology Medical Group PTY LTD ( Site 1700), Johannesburg
Southern Medical Day Care Centre ( Site 2303), Wollongong
Box Hill Hospital ( Site 2300), Box Hill
University of Debrecen Medical Center Clinic of Oncology ( Site 3300), Debrecen
Universitaetsspital Basel ( Site 1900), Basel
The Oncology Centre Overport and Umhlanga ( Site 1705), Durban
Odense Universitets Hospital ( Site 3201), Odense
Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302), Szolnok
Bacs-Kiskun Megyei Korhaz ( Site 3306), Kecskemét
Luzern Kantonsspital ( Site 1904), Lucerne
Cancer Care Langenhoven Drive Oncology Centre ( Site 1708), Port Elizabeth
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905), Bellinzona
Outeniqua Cancercare Oncology Unit ( Site 1704), George
Kantonsspital Graubuenden ( Site 1903), Chur
Cape Town Oncology Trials Pty Ltd ( Site 1703), Kraaifontein
Cancercare Rondebosch Oncology ( Site 1709), Cape Town
Groote Schuur Hospital ( Site 1706), Cape Town
Universitaetsspital Zuerich ( Site 1902), Zurich
Aalborg University Hospital ( Site 3204), Aalborg
Kantonsspital St. Gallen ( Site 1901), Sankt Gallen
Universitas Annex National Hospital ( Site 1701), Bloemfontein
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001), San José
Policlinico San Bosco ( Site 3002), San José
ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000), San José
Charite Universitaetsmedizin Berlin ( Site 1101), Berlin
Instituto Nacional de Cancerologia. ( Site 0804), Mexico City
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806), Mexico City
University of Rochester ( Site 0122), Rochester
Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908), Lima
Instituto Nacional de Enfermedades Neoplasicas ( Site 0901), Lima
Hospital Nacional Arzobispo Loayza ( Site 0902), Lima
Clinica San Gabriel ( Site 0907), Lima
Allegheny General Hospital ( Site 0118), Pittsburgh
Cancer Treatment Centers of America - Philadelphia ( Site 0112), Philadelphia
Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402), Milan
Istituto Europeo di Oncologia ( Site 1411), Milan
Facharztzentrum Eppendorf ( Site 1121), Hamburg
Greater Baltimore Medical Center ( Site 0102), Baltimore
Trakya Universitesi Tip Fakultesi ( Site 2015), Edirne
Asklepios Klinik Altona ( Site 1100), Hamburg
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001), Roanoke
CHU-Jean Minjoz ( Site 1002), Besançon
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000), Erzurum
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805), Pozuelo de Alarcón
C.H.R.U. de Brest - Hopital Morvan ( Site 1007), Brest
Hospital Universitario General de Asturias ( Site 1802), Oviedo
University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113), Miami
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001), Istanbul
Istituto Oncologico Veneto ( Site 1412), Padua
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011), Izmir
Hospital Universitario Marques de Valdecilla ( Site 1804), Santander
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808), Guadalajara
Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009), Malatya
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004), Saint-Herblain
City Clinical Hosp.4 of DCC ( Site 2201), Dnipro
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200), Kryviy Rih
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012), Sakarya
Minnesota Oncology Hematology, PA ( Site 8000), Minneapolis
Centre Oscar Lambret ( Site 1003), Lille
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208), Kharkiv
Christus Muguerza Clinica Vidriera ( Site 0802), Monterrey
MI Odessa Regional Oncological Centre ( Site 2212), Odesa
Masarykuv onkologicky ustav ( Site 3103), Brno
Medical Centre LLC Oncolife ( Site 2202), Zaporizhzhya
National Cheng Kung University Hospital ( Site 2901), Tainan City
SLK-Kliniken Heilbronn ( Site 1104), Heilbronn
Nemocnice AGEL Novy Jicin a.s. ( Site 3104), Nový Jičín
CHU Hopital Saint Antoine ( Site 1001), Paris
CHU de Rouen ( Site 1006), Rouen
MI Precarpathian Clinical Oncology Center ( Site 2204), Ivano-Frankivsk
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210), Lviv
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902), Kaohsiung City
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124), Los Angeles
UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128), Orange
Institut Gustave Roussy ( Site 1000), Villejuif
Medical Care and Research S.A. de C.V. ( Site 0809), Mérida
Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116), Wenatchee
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421), Beijing
National Taiwan University Hospital ( Site 2900), Taipei
Peking Union Medical College Hospital ( Site 2425), Beijing
Instituto Nacional de Cancerologia E.S.E ( Site 0605), Bogotá
Blokhin National Medical Oncology ( Site 1604), Moscow
Central Clinical Hospital with Polyclinic ( Site 1614), Moscow
The First Hospital of Jilin University ( Site 2416), Changchun
Harbin Medical University Cancer Hospital ( Site 2401), Harbin
SBHI Leningrad Regional Clinical Hospital ( Site 1616), Saint Petersburg
City Clinical Oncology Center ( Site 1603), Saint Petersburg
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608), Valledupar
Shanghai East Hospital ( Site 2403), Shanghai
Zhongshan Hospital affiliated to Fudan University ( Site 2407), Shanghai
The 81st Hospital of PLA ( Site 2413), Nanjing
Jiangsu Cancer Hospital ( Site 2432), Nanjing
Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441), Changzhou
Yancheng First People s Hospital ( Site 2426), Yancheng
Oncomedica S.A. ( Site 0606), Montería
The Affiliated Hospital of Qingdao University ( Site 2405), Qingdao
Zhejiang Provincial People's Hospital ( Site 2446), Hangzhou
Sir Run Run Show Hospital ( Site 2427), Hangzhou
Zhejiang Cancer Hospital ( Site 2417), Hangzhou
The First Affiliated Hospital of Nanchang University ( Site 2440), Nanchang
Fujian Medical University Union Hospital ( Site 2410), Fuzhou
Fujian Provincial Cancer Hospital ( Site 2414), Fuzhou
900 Hospital of the Joint ( Site 2418), Fuzhou
The First Affiliated Hospital of Xiamen University ( Site 2430), Xiamen
Zhongshan Hospital Xiamen University ( Site 2447), Xiamen
Xiangya Hospital Central-South University ( Site 2419), Changsha
Hunan Cancer Hospital ( Site 2439), Changsha
Hubei Cancer Hospital ( Site 2434), Wuhan
SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609), Samara
Henan Cancer Hospital ( Site 2415), Zhengzhou
Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608), Chelyabinsk
Guangdong General Hospital ( Site 2431), Guangzhou
Peking University Shenzhen Hospital ( Site 2442), Shenzhen
1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428), XiAn
Centro Medico Imbanaco de Cali S.A ( Site 0604), Santiago de Cali
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420), Ürümqi
Rambam Medical Center ( Site 1303), Haifa
Meir Medical Center ( Site 1308), Kfar Saba
Instituto Clinico Oncologico del Sur ( Site 0500), Temuco
Rabin Medical Center ( Site 1302), Petah Tikva
Chaim Sheba Medical Center ( Site 1304), Ramat Gan
Edith Wolfson Medical Center ( Site 1307), Holon
Sourasky Medical Center ( Site 1306), Tel Aviv
Fundacion Arturo Lopez Perez FALP ( Site 0501), Santiago
Sociedad Oncovida S.A. ( Site 0508), Santiago
Pontificia Universidad Catolica de Chile ( Site 0502), Santiago
Soroka University Medical Center ( Site 1305), Beersheba
Hadassah Ein Karem Jerusalem ( Site 1301), Jerusalem
Instituto Medico Alexander Fleming ( Site 0307), Buenos Aires
Instituto de Investigaciones Metabolicas ( Site 0312), Buenos Aires
Fundacion Favaloro - Hospital Universitario ( Site 0302), Buenos Aires
Centro Oncologico Riojano Integral ( Site 0313), La Rioja
Instituto San Marcos ( Site 0311), San Juan
Instituto do Cancer do Ceara ( Site 0407), Fortaleza
CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405), Curitiba
Hospital de Caridade de Ijui ( Site 0402), Ijuí
Hospital Nossa Senhora da Conceicao ( Site 0403), Porto Alegre
CEPON - Centro de Pesquisas Oncologicas ( Site 0400), Florianópolis
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401), Rio de Janeiro
IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404), São Paulo
BC Cancer - Abbotsford ( Site 0206), Abbotsford
Sunnybrook Research Institute ( Site 0202), Toronto
Princess Margaret Cancer Centre ( Site 0203), Toronto
McGill University Health Centre ( Site 0208), Montreal
Fourth Hospital Of Hebei Medical University ( Site 2436), Shijiazhuang
FN Ostrava ( Site 3105), Ostrava
Fakultni nemocnice Plzen ( Site 3102), Pilsen
Fakultni nemocnice Olomouc ( Site 3100), Olomouc
Fakultni Thomayerova nemocnice ( Site 3101), Prague
Universitaetsklinikum Leipzig ( Site 1114), Leipzig
Celan SA ( Site 0705), Guatemala City
Oncomedica ( Site 0702), Guatemala City
Grupo Angeles SA ( Site 0701), Guatemala City
MEDI-K CAYALA ( Site 0704), Guatemala City
Centro Regional de Sub Especialidades Medicas SA ( Site 0703), Quetzaltenango
Prince of Wales Hospital ( Site 2503), Hong Kong
Princess Margaret Hospital. ( Site 2502), Hong Kong
Queen Mary Hospital ( Site 2501), Hong Kong
St. James s Hospital ( Site 1200), Dublin
Beaumont Hospital ( Site 2101), Dublin
Tallaght University Hospital ( Site 1202), Dublin
Azienda Ospedaliera San Camillo Forlanini ( Site 1413), Roma
Aichi Cancer Center Hospital ( Site 2619), Nagoya
National Cancer Center Hospital East ( Site 2617), Kashiwa
Hyogo Cancer Center ( Site 2604), Akashi
Kobe City Medical Center General Hospital ( Site 2603), Kobe
Ibaraki Prefectural Central Hospital ( Site 2610), Kasama
Kagawa University Hospital ( Site 2615), Kita-gun
Kitasato University Hospital ( Site 2618), Sagamihara
Kanagawa Cancer Center ( Site 2614), Yokohama
Kansai Medical University Hospital ( Site 2608), Hirakata
Kindai University Hospital ( Site 2616), Sayama
Osaka University Hospital ( Site 2600), Suita
Saitama Cancer Center ( Site 2601), Kitaadachi-gun
National Hospital Organization Kyushu Cancer Center ( Site 2612), Fukuoka
Hiroshima City Hiroshima Citizens Hospital ( Site 2611), Hiroshima
Kumamoto University Hospital ( Site 2602), Kumamoto
Niigata Cancer Center Hospital ( Site 2613), Niigata
Osaka International Cancer Institute ( Site 2607), Osaka
National Cancer Center Hospital ( Site 2606), Tokyo
Tokyo Metropolitan Komagome Hospital ( Site 2605), Tokyo
The Cancer Institute Hospital of JFCR ( Site 2609), Tokyo
Przychodnia Lekarska Komed ( Site 1514), Konin
Szpital Uniwersytecki w Krakowie ( Site 1503), Krakow
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506), Wroclaw
Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504), Wroclaw
Magodent Szpital Elblaska ( Site 1509), Warsaw
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warsaw
Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505), Grudziądz
Tshwane District Hospital ( Site 1702), Pretoria
Seoul National University Hospital ( Site 2803), Seoul
Severance Hospital Yonsei University Health System ( Site 2800), Seoul
Asan Medical Center ( Site 2802), Seoul
Samsung Medical Center ( Site 2801), Seoul
Hospital General Universitario de Elche ( Site 1803), Elche
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806), Badalona
Hospital General Universitari Vall d Hebron ( Site 1801), Barcelona
Adana Sehir Hastanesi ( Site 2002), Adana
Hacettepe University Medical Faculty ( Site 2017), Ankara
Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006), Ankara
Clinic of National Cancer Institute ( Site 2203), Kyiv
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205), Kyiv
Kyiv City Clinical Oncology Centre ( Site 2213), Kyiv
South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205), Torquay
Castle Hill Hospital ( Site 1201), Cottingham
University College London Hospital ( Site 1211), London
St. Georges University Hospital NHS Foundation Trust ( Site 1204), London
Merck Sharp & Dohme LLC
INDUSTRY