450
Participants
Start Date
May 22, 2020
Primary Completion Date
June 30, 2028
Study Completion Date
December 31, 2029
Lenvatinib
Administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) via oral capsules once a day during each 21-day cycle.
Pembrolizumab
Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).
Oral Placebo
Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.
IV Placebo
Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).
TACE
Conducted as a background procedure of chemotherapeutic and embolic agent(s).
Chang Gung Medical Foundation. Linkou ( Site 0607), Taoyuan District
Taichung Veterans General Hospital ( Site 0613), Taichung
Kaohsiung Medical University Hospital ( Site 0611), Kaohsiung City
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609), Kaohsiung City
Auckland City Hospital ( Site 0459), Auckland
Semmelweis University ( Site 0264), Budapest
Westmead Hospital-Gastroenterology & Hepatology ( Site 0009), Westmead
St George Hospital ( Site 0005), Kogarah
Herlev Hospital ( Site 0170), Herlev
Alfred Health ( Site 0004), Melbourne
Austin Health ( Site 0008), Heidelberg
Princess Alexandra Hospital ( Site 0006), Brisbane
Odense Universitetshospital ( Site 0160), Odense
Royal Perth Hospital ( Site 0002), Perth
Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267), Kaposvár
Aarhus Universitets hospital ( Site 0175), Aarhus N
Zala Megyei Szent Rafael Korhaz ( Site 0265), Zalaegerszeg
National Taiwan University Hospital ( Site 0606), Taipei
Icahn School of Medicine at Mount Sinai ( Site 0744), New York
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333), Turin
Chulalongkorn University ( Site 0627), Bangkok
Ramathibodi Hospital, Mahidol University ( Site 0628), Bangkok
Faculty of Medicine Siriraj Hospital ( Site 0629), Bangkok
Monter Cancer Center ( Site 0780), Lake Success
Hopital de la Timone ( Site 0188), Marseille
Charite - Universitaetsmedizin ( Site 0204), Berlin
Seoul National University Bundang Hospital ( Site 0570), Seongnam-si
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325), Milan
ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331), Milan
Universitaetsklinikum Hamburg-Eppendorf ( Site 0207), Hamburg
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648), Edirne
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215), Lübeck
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334), Brescia
Edwards Comprehensive Cancer Center ( Site 0786), Huntington
Wake Forest Baptist Health ( Site 0741), Winston-Salem
Hospital General Universitario Gregorio Maranon ( Site 0598), Madrid
Hospital Ramon y Cajal ( Site 0593), Madrid
Hospital Clinico San Carlos ( Site 0597), Madrid
Hospital Universitario Puerta de Hierro ( Site 0596), Majadahonda
Medizinische Hochschule Hannover ( Site 0200), Hanover
CHU Bordeaux Haut-Leveque ( Site 0185), Pessac
Tampa General Hospital ( Site 0764), Tampa
Bezmialem Vakf Üniversitesi-Oncology ( Site 0660), Istanbul
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654), Izmir
I.E.U. Medical Point Hastanesi ( Site 0649), Izmir
University of Louisville ( Site 0757), Louisville
China Medical University Hospital-Surgical Department ( Site 0610), Taichung
Hospital Virgen del Rocio ( Site 0591), Seville
Kyungpook National University Hospital ( Site 0569), Daegu
Konya Necmettin Erbakan University Medical Faculty ( Site 0652), Konya
The Ohio State University Wexner Medical Center ( Site 0759), Columbus
ProMedica Flower Hospital ( Site 0796), Sylvania
Inonu Universitesi Medical Fakultesi ( Site 0650), Malatya
University of Cincinnati Medical Center ( Site 0791), Cincinnati
Hospital General Universitario de Valencia ( Site 0595), Valencia
Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332), Ravenna
Henry Ford Hospital-GI/Hepatology Research ( Site 0735), Detroit
Pusan National University Hospital ( Site 0568), Busan
University of Iowa Hospital and Clinics ( Site 0729), Iowa City
Universitaetsklinikum Bonn ( Site 0203), Bonn
C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180), Vandœuvre-lès-Nancy
Chonnam National University Hwasun Hospital ( Site 0572), Hwasun
Krankenhaus Nord-West GmbH ( Site 0208), Frankfurt am Main
Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669), Kharkiv
Saint Louis University ( Site 0769), St Louis
University of Kansas Cancer Center ( Site 0731), Westwood
Hopital de la Croix-Rousse ( Site 0193), Lyon
Tulane Medical Center ( Site 0787), New Orleans
University Medical Center New Orleans ( Site 0733), New Orleans
National Cheng Kung University Hospital ( Site 0608), Tainan City
Stephenson Cancer Center ( Site 0745), Oklahoma City
Houston Methodist Research Institute ( Site 0784), Houston
Universitaetsklinikum Freiburg ( Site 0199), Freiburg im Breisgau
Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329), Napoli
Ospedale del Mare ( Site 0327), Napoli
Mountain States Tumor Institute ( Site 0773), Boise
Arizona Oncology Associates PC- HOPE ( Site 0770), Tucson
University of New Mexico Comprehensive Cancer Center ( Site 0805), Albuquerque
USC Norris Comprehensive Cancer Center ( Site 0717), Los Angeles
UCLA Hematology/Oncology - Santa Monica ( Site 0720), Los Angeles
Scripps Clinic Torrey Pines ( Site 0714), La Jolla
UC Irvine Health ( Site 0718), Orange
A.P.H. Paris, Hopital Henri Mondor ( Site 0179), Créteil
Hopital Paul Brousse ( Site 0182), Villejuif
OHSU Center for Health & Healing ( Site 0746), Portland
AOU Policlinico G. Martino ( Site 0324), Messina
Beijing Cancer Hospital ( Site 0099), Beijing
Beijing Cancer Hospital ( Site 0105), Beijing
Peking Union Medical College Hospital ( Site 0087), Beijing
Administradora Country S.A. ( Site 0137), Bogotá
Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine ( Site 0612), Taipei
Harbin Medical University Cancer Hospital ( Site 0090), Harbin
The Third Affiliated Hospital of the PLA Navy Medical University ( Site 0123), Shanghai
Fudan University Shanghai Cancer Center ( Site 0106), Shanghai
Zhongshan Hospital Fudan University ( Site 0084), Shanghai
The First Affiliated Hospital of Soochow University ( Site 0120), Suzhou
Anhui Provincial Hospital ( Site 0092), Heifei
Tianjin Medical University Cancer Institute & Hospital ( Site 0098), Tianjin
Tianjin Third Central Hospital ( Site 0861), Tianjin
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110), Hangzhou
Sir Run Run Shaw Hospital ( Site 0094), Hangzhou
Zhejiang Cancer Hospital ( Site 0103), Hangzhou
Ningbo Medical Center LiHuili Hospital ( Site 0132), Ningbo
Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134), Nanchang
Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121), Fuzhou
Fujian Provincial Cancer Hospital ( Site 0085), Fuzhou
The First Affiliated Hospital of Fujian Medical University ( Site 0089), Fuzhou
Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133), Xiamen
Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117), Chongqing
Chongqing University Three Gorges Hospital ( Site 0859), Chongqing
Hunan Provincial People's Hospital ( Site 0113), Changsha
Hunan Cancer Hospital ( Site 0096), Changsha
Tongji Hospital Tongji Medical,Science & Technology ( Site 0126), Wuhan
Hubei Cancer Hospital ( Site 0101), Wuhan
Henan Cancer Hospital ( Site 0114), Zhengzhou
Zhujiang Hospital of Southern Medical University ( Site 0115), Guangzhou
Guangdong Provincial People s Hospital ( Site 0100), Guangzhou
NANFANG HOSPITAL SOUTHERN MEDICAL UNIVERSITY ( Site 0088), Guangzhou
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0128), Guangzhou
Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856), Zhuhai
Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862), Nanning
Hainan General Hospital ( Site 0112), Haikou
West China Hospital of Sichuan University ( Site 0119), Chengdu
Suining Central Hospital ( Site 0857), Suining
The First Hospital of Kunming ( Site 0124), Kunming
Fundacion Cardiovascular de Colombia ( Site 0136), Piedecuesta
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108), Xi’an
Xi'an International Medical Center Hospital ( Site 0860), Xi'an
Fundación Valle del Lili ( Site 0140), Santiago de Cali
Emek Medical Center ( Site 0307), Afula
Rambam Health Care Campus-Oncology Division ( Site 0305), Haifa
Centro Investigación del Cáncer James Lind ( Site 0064), Temuco
Sourasky Medical Center ( Site 0306), Tel Aviv
Centro de Oncología de Precisión-Oncology ( Site 0068), Santiago
National Hospital Organization Kyushu Medical Center ( Site 0361), Fukuoka
Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065), Santiago
Bradfordhill ( Site 0066), Santiago
Hadassah Ein Karem Jerusalem ( Site 0303), Jerusaelm
Yale Cancer Center ( Site 0724), New Haven
Penn State Hershey Medical Center ( Site 0766), Hershey
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057), Natal
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056), Porto Alegre
Clinica de Oncologia Reichow ( Site 0052), Blumenau
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058), Barretos
Fundacao Dr Amaral Carvalho ( Site 0050), Jaú
Hospital de Base de Sao Jose de Rio Preto ( Site 0043), São José do Rio Preto
BP - A Beneficencia Portuguesa de São Paulo ( Site 0046), São Paulo
A.C. Camargo Cancer Center ( Site 0054), São Paulo
Hospital Pablo Tobon Uribe ( Site 0145), Medellín
Universitaetsklinikum Leipzig ( Site 0202), Leipzig
Universitaetsklinikum Halle ( Site 0213), Halle
Prince of Wales Hospital ( Site 0242), Shatin
St Vincents University Hospital ( Site 0690), Dublin
Rabin Medical Center ( Site 0304), Petah Tikva
Policlinico Universitario -Agostino Gemelli ( Site 0328), Roma
National Cancer Center Hospital East ( Site 0347), Kashiwa
Ehime University Hospital ( Site 0368), Tōon
Kurume University Hospital ( Site 0362), Kurume
Sapporo Kosei General Hospital ( Site 0345), Sapporo
Kanazawa University Hospital ( Site 0354), Kanazawa
Kagawa Prefectural Central Hospital ( Site 0364), Takamatsu
Toranomon Hospital Kajigaya ( Site 0369), Kawasaki
Yokohama City University Medical Center ( Site 0351), Yokohama
Kanagawa Cancer Center ( Site 0352), Yokohama
Nara Medical University Hospital ( Site 0359), Kashihara
Kindai University Hospital ( Site 0358), Sayama
Saitama Medical University Hospital ( Site 0370), Iruma-gun
Shizuoka Cancer Center ( Site 0365), Suntogun
Jichi Medical University Hospital ( Site 0353), Shimotsuke
Chiba University Hospital ( Site 0346), Chiba
Hiroshima University Hospital ( Site 0360), Hiroshima
Kumamoto University Hospital ( Site 0372), Kumamoto
University Hospital,Kyoto Prefectural University of Medicine ( Site 0367), Kyoto
Osaka International Cancer Institute ( Site 0357), Osaka
Japanese Red Cross Osaka Hospital ( Site 0356), Osaka
Saga-Ken Medical Centre Koseikan ( Site 0363), Saga
Toranomon Hospital ( Site 0349), Tokyo
Juntendo University Hospital ( Site 0371), Tokyo
The University of Tokyo Hospital ( Site 0348), Tokyo
Maastricht University Medical Centre ( Site 0440), Maastricht
AMC ( Site 0438), Amsterdam
Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442), Leiden
Erasmus University Medical Center ( Site 0439), Rotterdam
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441), Utrecht
Oslo Universitetssykehus Ullevål ( Site 0500), Oslo
Centro Hospitalar e Universitario de Coimbra ( Site 0502), Coimbra
Unidade Local de Saude de São José - Hospital de Santo Antonio dos Capuchos ( Site 0505), Lisbon
Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504), Porto
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503), Porto
Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501), Porto
Puerto Rico Medical Research Center LLC ( Site 0523), Hato Rey
Ad-Vance Medical Research LLC ( Site 0527), Ponce
VA Caribbean Healthcare System ( Site 0524), San Juan
FDI Clinical Research ( Site 0522), San Juan
Seoul National University Hospital ( Site 0567), Seoul
Severance Hospital Yonsei University Health System ( Site 0564), Seoul
Asan Medical Center ( Site 0565), Seoul
Samsung Medical Center ( Site 0566), Seoul
The Catholic University of Korea St. Mary s Hospital ( Site 0571), Seoul
Korea University Guro Hospital ( Site 0573), Seoul
Hacettepe University Medical Faculty ( Site 0653), Ankara
Ankara City Hospital-Medical Oncology ( Site 0661), Ankara
Barts Health NHS Trust ( Site 0692), London
Royal Marsden NHS Foundation Trust ( Site 0694), London
Royal Marsden NHS Trust ( Site 0693), Sutton
Eisai Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY