738
Participants
Start Date
October 5, 2018
Primary Completion Date
March 20, 2024
Study Completion Date
November 12, 2025
Pembrolizumab
200 mg on Day 1 of each 3-week cycle as an IV infusion.
Placebo
Solution for IV infusion on Day 1 of each 3-week cycle.
Cisplatin
80 mg/m\^2 on Day 1 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen.
5-FU
800 mg/m\^2/day continuous on Days 1-5 of each 3-week cycle (120 hours or per local standard), administered as part of FP chemotherapy regimen.
Oxaliplatin
130 mg/m\^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen and as part of SOX chemotherapy regimen.
Capecitabine
1000 mg/m\^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.
S-1
Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): \<1.25 m\^2 BSA =40 mg, 1.25 to \<1.5 m\^2 BSA=50 mg, ≥1.5 m\^2 BSA=60 mg. Administered as part of SOX chemotherapy regimen.
Trastuzumab
8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.
Auckland City Hospital ( Site 2300), Auckland
Westmead Hospital ( Site 2200), Westmead
Liverpool Hospital ( Site 2206), Liverpool
Southern Medical Day Care Centre ( Site 2207), Wollongong
Monash Health ( Site 2202), Clayton
Memorial Sloan-Kettering Cancer Center ( Site 0017), New York
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065), Harrison
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 1026), Berlin
University of Rochester ( Site 0041), Rochester
Allegheny General Hospital ( Site 0053), Pittsburgh
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025), Philadelphia
IEO Istituto Europeo di Oncologia ( Site 1105), Milan
Facharztzentrum Eppendorf ( Site 1025), Hamburg
Trakya Universitesi Tip Fakultesi ( Site 2015), Edirne
Asklepios Klinik Altona ( Site 1000), Hamburg
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000), Roanoke
Humanitas Gavazzeni ( Site 1106), Bergamo
Hopital Jean Minjoz Besancon ( Site 0901), Besançon
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000), Erzurum
Duke Cancer Institute ( Site 0042), Durham
Hospital Universitario Ramon y Cajal ( Site 1400), Madrid
Levine Cancer Institute ( Site 0015), Charlotte
Klinikum Bremen Nord ( Site 1017), Bremen
Hospital Universitario Quiron Madrid ( Site 1407), Pozuelo de Alarcón
C.H.R.U. de Brest - Hopital Morvan ( Site 0913), Brest
Southeastern Regional Medical Center, Inc. ( Site 0058), Newnan
Medizinische Hochschule Hannover ( Site 1019), Hanover
Hospital Universitario Central de Asturias ( Site 1402), Oviedo
University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026), Miami
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001), Istanbul
Istituto Oncologico Veneto ( Site 1101), Padua
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011), Izmir
Hospital Universitario Marques de Valdecilla ( Site 1405), Santander
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1102), Modena
Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009), Malatya
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902), Saint-Herblain
City Clinical Hosp.4 of DCC ( Site 2102), Dnipro
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2101), Kryviy Rih
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012), Sakarya
Minnesota Oncology Hematology, PA ( Site 8001), Minneapolis
AUOP Ospedale Santa Chiara ( Site 1100), Pisa
Sanford Hematology Oncology-Sioux Falls SD ( Site 0004), Sioux Falls
Centre Oscar Lambret ( Site 0911), Lille
Midwestern Regional Medical Center, Inc. ( Site 0059), Zion
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2112), Kharkiv
Washington University School of Medicine ( Site 0040), St Louis
MI Odessa Regional Oncological Centre ( Site 2108), Odesa
Ospedale Civile Spirito Santo ( Site 1104), Pescara
HUS Hopital Hautepierre ( Site 0910), Strasbourg
Centre Leon Berard ( Site 0904), Lyon
Medical Centre LLC Oncolife ( Site 2103), Zaporizhzhya
Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020), Tübingen
SLK-Kliniken Heilbronn ( Site 1015), Heilbronn
CTCA Southwestern ( Site 0060), Tulsa
CHU Hopital Saint Antoine ( Site 0905), Paris
CHU de Rouen ( Site 0912), Rouen
MI Precarpathian Clinical Oncology Center ( Site 2105), Ivano-Frankivsk
University of Texas MD Anderson Cancer Center ( Site 0001), Houston
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2106), Lviv
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1103), Napoli
Klinikum rechts der Isar der Technischen Universitaet ( Site 1027), Munich
Universita Magna Graecia di Catanzaro ( Site 1107), Catanzaro
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045), Los Angeles
UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050), Orange
Pacific Cancer Care ( Site 0063), Monterey
Institut Gustave Roussy ( Site 0900), Villejuif
Seattle Cancer Care Alliance ( Site 0038), Seattle
Peking Union Medical College Hospital ( Site 2419), Beijing
Fifth Medical Center of CPLA General Hospital ( Site 2415), Beijing
Beijing Cancer Hospital ( Site 2413), Beijing
Blokhin National Medical Oncology ( Site 1805), Moscow
The First Hospital Of Jilin University ( Site 2402), Changchun
Podolsky City Clinical Hospital ( Site 1817), Podolsk
Harbin Medical University Cancer Hospital ( Site 2407), Harbin
Leningrad Regional Oncology Center ( Site 1800), Saint Petersburg
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1801), Saint Petersburg
St Petersburg City Clinical Oncology Dispensary ( Site 1812), Saint Petersburg
Fudan University Shanghai Cancer Center ( Site 2424), Shanghai
Zhongshan Hospital affiliated to Fudan University ( Site 2401), Shanghai
Shanghai General Hospital ( Site 2404), Shanghai
Jiangsu Cancer Hospital ( Site 2432), Nanjing
The First Affiliated Hospital.Zhejiang University ( Site 2408), Hangzhou
Sir Run Run Shaw Hospital ( Site 2412), Hangzhou
Zhejiang Cancer Hospital ( Site 2409), Hangzhou
Fujian Provincial Cancer Hospital ( Site 2418), Fuzhou
900 Hospital of the Joint ( Site 2420), Fuzhou
The First Affiliated Hospital of Xiamen University ( Site 2431), Xiamen
Xiangya Hospital Central-South University ( Site 2426), Changsha
Medical University REAVIZ ( Site 1816), Samara
Henan Cancer Hospital ( Site 2400), Zhengzhou
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1807), Ufa
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1815), Chelyabinsk
Guangdong General Hospital ( Site 2433), Guangzhou
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430), Ürümqi
Rambam Health Care Campus ( Site 1606), Haifa
Clinica Universidad Catolica del Maule ( Site 0305), Talca
Meir Medical Center ( Site 1609), Kfar Saba
Centro Investigación del Cáncer James Lind ( Site 0300), Temuco
Rabin Medical Center ( Site 1602), Petah Tikva
Chaim Sheba Medical Center. ( Site 1607), Ramat Gan
Edith Wolfson Medical Center ( Site 1605), Holon
Sourasky Medical Center ( Site 1601), Tel Aviv
Fundacion Arturo Lopez Perez FALP ( Site 0302), Santiago
Pontificia Universidad Catolica de Chile ( Site 0301), Santiago
Instituto Nacional del Cancer ( Site 0303), Santiago
Soroka University Medical Center ( Site 1603), Beersheba
Hadassah Ein Kerem Medical Center ( Site 1604), Jerusalem
Beth Israel Deaconess Medical Center ( Site 0070), Boston
Dana-Farber Cancer Institute [Boston, MA] ( Site 0010), Boston
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071), Middletown
Instituto do Cancer do Ceara ( Site 0208), Fortaleza
Hospital Sao Rafael ( Site 0209), Salvador
CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205), Curitiba
Hospital de Caridade de Ijui ( Site 0202), Ijuí
Hospital Nossa Senhora da Conceicao ( Site 0203), Porto Alegre
CEPON - Centro de Pesquisas Oncologicas ( Site 0200), Florianópolis
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201), Rio de Janeiro
IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204), São Paulo
Klinikum Ludwigsburg ( Site 1014), Ludwigsburg
Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001), Dresden
Universitaetsklinikum Leipzig AOeR ( Site 1007), Leipzig
Celan SA ( Site 0504), Guatemala City
Oncomedica ( Site 0500), Guatemala City
Grupo Angeles SA ( Site 0501), Guatemala City
Nucare Center ( Site 0506), Guatemala City
Medi-K Cayala ( Site 0505), Guatemala City
Centro Regional de Sub Especialidades Medicas SA ( Site 0502), Quetzaltenango
Saint James's Hospital ( Site 1505), Dublin
Beaumont Hospital ( Site 1506), Dublin
Tallaght University Hospital ( Site 1513), Dublin
Aichi Cancer Center Hospital ( Site 2617), Nagoya
National Cancer Center Hospital East ( Site 2605), Kashiwa
National Hospital Organization Shikoku Cancer Center ( Site 2615), Matsuyama
Gunma Prefectural Cancer Center ( Site 2602), Ohta
Hyogo Cancer Center ( Site 2619), Akashi
Kobe City Medical Center General Hospital ( Site 2614), Kobe
Ibaraki Prefectural Central Hospital ( Site 2611), Kasama
Kagawa University Hospital ( Site 2604), Kita-gun
Kanagawa Cancer Center ( Site 2603), Yokohama
Osaki Citizen Hospital ( Site 2626), Ōsaki
Kansai Medical University Hospital ( Site 2618), Hirakata
Kindai University Hospital ( Site 2616), Sayama
Osaka University Hospital ( Site 2600), Suita
Saitama Cancer Center ( Site 2620), Kitaadachi-gun
Shizuoka Cancer Center Hospital and Research Institute ( Site 2607), Sunto-gun
Tochigi Cancer Center ( Site 2627), Utsunomiya
Kyorin University Hospital ( Site 2608), Mitaka
Chiba Cancer Center ( Site 2623), Chiba
National Hospital Organization Kyushu Cancer Center ( Site 2609), Fukuoka
Gifu University Hospital ( Site 2621), Gifu
Hiroshima City Hiroshima Citizens Hospital ( Site 2625), Hiroshima
Kumamoto University Hospital ( Site 2601), Kumamoto
Niigata Cancer Center Hospital ( Site 2622), Niigata
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26, Osaka
Osaka International Cancer Institute ( Site 2613), Osaka
Osaka General Medical Center ( Site 2624), Osaka
National Cancer Center Hospital ( Site 2612), Tokyo
Toranomon Hospital ( Site 2628), Tokyo
Tokyo Metropolitan Komagome Hospital ( Site 2606), Tokyo
The Cancer Institute Hospital of JFCR ( Site 2610), Tokyo
Przychodnia Lekarska Komed ( Site 1716), Konin
Uniwersytecki Szpital Kliniczny im. J. M. Radeckiego we Wroclawiu ( Site 1705), Wroclaw
Dolnoslaskie Centrum Onkologii. ( Site 1712), Wroclaw
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1709), Lublin
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warsaw
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1715), Gdynia
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1708), Kościerzyna
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1710), Bielsko-Biala
Seoul National University Hospital ( Site 2703), Seoul
Severance Hospital Yonsei University Health System ( Site 2700), Seoul
Asan Medical Center ( Site 2702), Seoul
Samsung Medical Center ( Site 2701), Seoul
Hospital General Universitario de Elche ( Site 1404), Elche
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1410), Badalona
Hospital General Universitari Vall d Hebron ( Site 1401), Barcelona
Adana Sehir Hastanesi ( Site 2002), Adana
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2017), Ankara
Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006), Ankara
Medical Center Asklepion LLC ( Site 2115), Khodosovka
Clinic of National Cancer Institute ( Site 2104), Kyiv
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2114), Kyiv
Kyiv City Clinical Oncology Centre ( Site 2110), Kyiv
Royal Hospital in Derby ( Site 1514), Derby
Ninewells Hospital and Medical School ( Site 1504), Dundee
Castle Hill Hospital ( Site 1501), Cottingham
University College London Hospital NHS Foundation Trust ( Site 1508), London
St Georges University Hospitals NHS Foundation Trust. ( Site 1500), London
Royal Marsden Hospital ( Site 1510), Sutton
Royal Marsden NHS Foundation Trust ( Site 1512), London
The Christie Hospital NHS Foundation Trust ( Site 1503), Manchester
Mount Vernon Cancer Centre ( Site 1507), Northwood
Manor Hospital Walsall England ( Site 1515), Walsall
Merck Sharp & Dohme LLC
INDUSTRY