863
Participants
Start Date
July 28, 2021
Primary Completion Date
May 8, 2025
Study Completion Date
January 31, 2027
Pembrolizumab
400 mg once every 6-week-cycle, via IV infusion.
Lenvatinib
8 mg QD (induction) or 20 mg QD (consolidation) via oral capsule.
Cisplatin
80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 75 mg/m\^2 Q3W via infusion, as part of investigator's choice TP chemotherapy.
5-FU
4000 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m\^2 Q2W via bolus IV infusion followed by 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Oxaliplatin
85 mg/m\^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Leucovorin
400 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Levoleucovorin
200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Paclitaxel
175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.
National Cheng Kung University Hospital ( Site 6004), Tainan City
Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005), Kaohsiung City
Orszagos Onkologiai Intezet ( Site 1207), Budapest
Rigshospitalet ( Site 2102), Copenhagen
Wits Clinical Research ( Site 9502), Johannesburg
The Oncology Centre ( Site 9505), Durban
Odense University Hospital ( Site 2101), Odense
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1203), Szolnok
Pecsi Tudomanyegyetem AOK ( Site 1204), Pécs
Petz Aladar Egyetemi Oktato Korhaz ( Site 1210), Győr
National Taiwan University Hospital ( Site 6001), Taipei
Memorial Sloan Kettering Cancer Center ( Site 0132), New York
Weill Cornell Medical College ( Site 0133), New York
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902), San José
Onco Tech S A ( Site 0901), San José
ICIMED-Oncology Research Unit ( Site 0903), San José
Faculty of Medicine Siriraj Hospital ( Site 7002), Bangkok
Taipei Veterans General Hospital ( Site 6006), Taipei
PROCLINICAL Pharma ( Site 0904), San José
Hematology-Oncology Associates of CNY ( Site 0173), East Syracuse
Seoul National University Bundang Hospital ( Site 5006), Seongnam-si
Chernihiv Medical Center of Modern Oncology ( Site 1811), Chernihiv
Centre François Baclesse ( Site 1009), Caen
AHN Allegheny General Hospital ( Site 0164), Pittsburgh
St. Luke's University Health Network ( Site 0185), Bethlehem
MedStar Washington Hospital Center ( Site 0186), Washington D.C.
Humanitas Research Hospital ( Site 1309), Rozzano
IRCCS Ospedale San Raffaele di Milano ( Site 1304), Milan
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306), Milan
Centre Georges Francois Leclerc ( Site 1008), Dijon
Podillya Regional Center of Oncology ( Site 1809), Vinnytsia
Johns Hopkins Bayview Medical Center ( Site 0152), Baltimore
VCU Health Adult Outpatient Pavillion ( Site 0160), Richmond
CHU Besançon ( Site 1015), Besançon
Atatürk Üniversitesi-onkoloji ( Site 1712), Erzurum
Hospital General Universitario Gregorio Maranon ( Site 1604), Madrid
C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( S, Brest
Medical University of South Carolina-Hollings Cancer Center ( Site 0177), Charleston
Complexo Hospitalario Universitario de Ourense-MEDICAL ONCOLOGY ( Site 1609), Ourense
Rivne Regional Clinical Hospital ( Site 1817), Rivne
Hospital Universitario General de Asturias ( Site 1601), Oviedo
A.O.U. Santa Maria della Misericordia di Udine ( Site 1302), Udine
CHU Bordeaux Haut-Leveque ( Site 1012), Pessac
Institut du Cancer de Montpellier ( Site 1002), Montpellier
Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 1716), Istanbul
Istanbul Okmeydanı Egitim ve Arastirma Hastanesi ( Site 1711), Istanbul
Medeniyet Universitesi Tip Fakultesi ( Site 1703), Istanbul
Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 1311), Padua
CHRU de Tours - Hopital Bretonneau ( Site 1018), Tours
Hospital Universitario Marques de Valdecilla ( Site 1602), Santander
James Graham Brown Cancer Center ( Site 0117), Louisville
Norton Cancer Institute ( Site 0116), Louisville
China Medical University Hospital ( Site 6003), Taichung
Hospital Virgen del Rocio ( Site 1606), Seville
A.O. Universitaria di Modena ( Site 1307), Modena
Volyn Regional Oncological Dispensary ( Site 1816), Lutsk
Institut De Cancerologie De L Ouest ( Site 1003), Saint-Herblain
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1313), Meldola
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804), Kryviy Rih
Azienda Ospedaliero Universitaria Careggi ( Site 1301), Florence
Hospital Kuala Lumpur ( Site 9104), Kuala Lumpur
Institut De Cancerologie De Lorraine ( Site 1010), Vandœuvre-lès-Nancy
Azienda Ospedaliera Universitaria Pisana ( Site 1312), Pisa
"Regional Municipal Non-profit Enterprise Bukovinian Clinical Oncology Center ( Site 1819)", Chernivtsi
Hôpital Claude Huriez ( Site 1030), Lille
University Malaya Medical Centre ( Site 9101), Lembah Pantai
Kharkiv Regional Clinical Oncology Center ( Site 1812), Kharkiv
Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813), Kharkiv
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1014), Strasbourg
"Communal nonprofit enterprise Kherson Regional Oncology Dispensary of Kherson Regional Council (", Antonivka Village
Chi Mei Hospital - Liouying Branch-Clinical Trial Center ( Site 6007), Tainan City
Hopital Saint Louis ( Site 1029), Paris
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305), Napoli
Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1314), Catanzaro
Songklanagarind hospital ( Site 7001), Hat Yai
City of Hope ( Site 0102), Duarte
Sarawak General Hospital-Radiotherapy Unit ( Site 9100), Kuching
Hopital Henri Mondor ( Site 1007), Créteil
Seattle Cancer Care Alliance ( Site 0145), Seattle
Beijing Cancer Hospital ( Site 8001), Beijing
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510), Moscow
Jilin Cancer Hospital ( Site 8016), Changchun
National Cancer Centre Singapore ( Site 9201), Singapore
GBUZ LOKB ( Site 1502), Saint-Petersburg
Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519), Saint Petersburg
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503), Saint Petersburg
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2204), Craiova
Affiliated hospital of Jiangnan university ( Site 8049), Wuxi
The Affiliated Hospital of Xuzhou Medical University ( Site 8015), Xuzhou
Anhui Provincial Cancer Hospital ( Site 8058), Hefei
The Second Affiliated Hospital of Anhui Medical University ( Site 8026), Hefei
Jinan Central Hospital ( Site 8052), Jinan
Shandong Cancer Hospital ( Site 8060), Jinan
Affiliated Hospital of Jining Medical University ( Site 8017), Jining
Linyi Cancer Hospital- Medical Oncology Department ( Site 8051), Linyi
Tianjin Medical University Cancer Institute & Hospital ( Site 8035), Tianjin
Policlinica Oncomed SRL ( Site 2206), Timișoara
Sir Run Run Shaw Hospital ( Site 8021), Hangzhou
Fujian Provincial Cancer Hospital ( Site 8029), Fuzhou
The First Affiliated Hospital of Xiamen University ( Site 8003), Xiamen City, Fujian Province
Zhongshan Hospital Affiliated to Xiamen University ( Site 8055), Xiamen
Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2207), Cluj-Napoca
SC Radiotherapy Center Cluj SRL ( Site 2202), Comuna Floresti
The Third Xiangya Hospital of Central South University ( Site 8046), Changsha
Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 150, Kazan'
Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025), Wuhan
Hubei Cancer Hospital ( Site 8014), Wuhan
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507), Ufa
The First Affiliated Hospital of Xinxiang Medical University ( Site 8018), Xinxiang
Anyang Cancer Hospital ( Site 8006), Anyang
The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036), Luoyang
The First Affiliated Hospital.Sun Yat-sen University ( Site 8047), Guangzhou
Southern Medical University Nanfang Hospital ( Site 8031), Guangzhou
The First Affiliated Hospital of Hainan Medical University ( Site 8042), Haikou
West China Hospital of Sichuan University ( Site 8048), Chengdu
"SAIH of Tyumen reg Multifield clinical medical center Medical city ( Site 1520)", Tyumen
The Affiliated Cancer Hospital of Xinjiang Medical University. ( Site 8041), Ürümqi
Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 2203), Ovidiu
James Lind Centro de Investigacion del Cancer ( Site 0412), Temuco
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401), Temuco
Fundacion Arturo Lopez Perez FALP ( Site 0403), Santiago
Oncovida ( Site 0413), Santiago
Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407), Santiago
Bradford Hill Centro de Investigaciones Clinicas ( Site 0404), Santiago
UMASS Memorial Medical Center ( Site 0120), Worcester
Capital Health Medical Center - Hopewell ( Site 0189), Pennington
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203), Berazategui
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202), CABA
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205), Mar del Plata
Fundacion Estudios Clinicos-Oncology ( Site 0215), Rosario
Sanatorio Parque ( Site 0206), Rosario
Hospital Provincial del Centenario ( Site 0217), Rosario
Fundacion Favaloro ( Site 0201), Buenos Aires
Fundación Respirar ( Site 0216), Buenos Aires
Hospital Italiano de Córdoba ( Site 0218), Córdoba
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221), La Rioja
Instituto San Marcos ( Site 0213), San Juan
CancerCare Manitoba ( Site 0001), Winnipeg
Princess Margaret Cancer Centre ( Site 0004), Toronto
Hotel-Dieu de Levis ( Site 0013), Lévis
Affiliated Hospital of Chengde Medical Univeristy ( Site 8053), Chengde
Harbin Medical University Cancer Hospital ( Site 8009), Harbin
Queen Mary Hospital ( Site 4001), Hong Kong
Queen Elizabeth Hospital. ( Site 4004), Kowloon
Kyoto University Hospital ( Site 9011), Kyoto
Shanxi Provincial Cancer Hospital ( Site 8019), Taiyuan
Centro Regional de Sub Especialidades Medicas SA ( Site 0604), Guatemala
MEDI-K ( Site 0601), Guatemala City
Oncomedica ( Site 0602), Guatemala City
Soluciones Gastrointestinales S.A. ( Site 0607), Guatemala City
Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310), Roma
Aichi Cancer Center Hospital ( Site 9006), Nagoya
Chiba Cancer Center ( Site 9023), Chiba
National Cancer Center Hospital East ( Site 9002), Kashiwa
National Hospital Organization Shikoku Cancer Center ( Site 9019), Matsuyama
Hyogo Cancer Center ( Site 9014), Akashi
Ibaraki Prefectural Central Hospital ( Site 9007), Kasama
Kagawa University Hospital ( Site 9015), Kita-gun
Kanagawa Cancer Center ( Site 9004), Yokohama
Tohoku University Hospital ( Site 9013), Sendai
Niigata Cancer Center Hospital ( Site 9022), Niigata
Kindai University Hospital ( Site 9017), Sayama
Osaka University Hospital ( Site 9021), Suita
Osaka Medical and Pharmaceutical University Hospital ( Site 9008), Takatsuki
Saitama Prefectural Cancer Center ( Site 9003), Kitaadachi-gun
Shizuoka Cancer Center ( Site 9016), Nakatogari
Tokyo Metropolitan Komagome Hospital ( Site 9028), Bunkyo Ku
Toranomon Hospital ( Site 9026), Minato-ku
Showa University Hospital ( Site 9025), Shinagawa
National Hospital Organization Kyushu Cancer Center ( Site 9010), Fukuoka
University Hospital,Kyoto Prefectural University of Medicine ( Site 9027), Kyoto
Okayama University Hospital ( Site 9024), Okayama
Osaka International Cancer Institute ( Site 9009), Osaka
Osaka General Medical Center ( Site 9018), Osaka
National Cancer Center Hospital ( Site 9001), Tokyo
The Cancer Institute Hospital of JFCR ( Site 9005), Tokyo
Keio University Hospital ( Site 9020), Tokyo
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2201), Bucharest
Asan Medical Center ( Site 5002), Songpagu
Severance Hospital ( Site 5003), Seoul
Samsung Medical Center ( Site 5005), Seoul
Korea University Guro Hospital ( Site 5001), Seoul
Hospital General Universitari Vall d Hebron ( Site 1607), Barcelona
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1714), Adana
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701), Ankara
Memorial Ankara Hastanesi ( Site 1702), Ankara
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1715), Ankara
SNPE National Cancer Institute ( Site 1806), Kyiv
Shalimov Institute of Surgery and Transplantation ( Site 1818), Kyiv
Cambridge University Hospitals NHSFT ( Site 1908), Cambridge
Ninewells Hospital and Medical School ( Site 1907), Dundee
Nottingham University Hospital NHS Trust ( Site 1910), Nottingham
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915), London
University College London Hospitals NHS Foundation Trust ( Site 1901), London
Royal Marsden NHS Foundation Trust ( Site 1905), London
Royal Marsden NHS Trust. ( Site 1906), Sutton
Western General Hospital ( Site 1912), Edinburgh
The Christie NHS Foundation Trust ( Site 1909), Manchester
Eisai Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY