Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)

PHASE3CompletedINTERVENTIONAL
Enrollment

794

Participants

Timeline

Start Date

December 31, 2018

Primary Completion Date

June 21, 2022

Study Completion Date

September 24, 2024

Conditions
Carcinoma, Hepatocellular
Interventions
DRUG

lenvatinib

Administered orally once a day

BIOLOGICAL

pembrolizumab

Administered as an IV infusion on Day 1 Q3W

DRUG

saline placebo

Administered as an IV infusion on Day 1 Q3W

Trial Locations (172)

100

National Taiwan University Hospital ( Site 0523), Taipei

112

Taipei Veterans General Hospital ( Site 0524), Taipei

333

Chang Gung Medical Foundation. Linkou ( Site 0525), Taoyuan District

404

China Medical University Hospital ( Site 0527), Taichung

407

Taichung Veterans General Hospital ( Site 0526), Taichung

807

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0529), Kaoshiung

1023

Auckland City Hospital ( Site 0376), Auckland

2050

Royal Prince Alfred Hospital ( Site 0001), Camperdown

2170

Liverpool Hospital. ( Site 0002), Liverpool

3065

St Vincents Hospital Melbourne ( Site 0003), Fitzroy

3168

Monash Health-Monash Medical Centre ( Site 0004), Clayton

4102

Princess Alexandra Hospital ( Site 0007), Wooloongabba

8011

Christchurch Hospital ( Site 0377), Christchurch

10029

Icahn School of Medicine at Mount Sinai ( Site 0611), New York

10700

Siriraj Hospital. Mahidol Univerisity ( Site 0213), Bangkok Noi

11794

Stony Brook University Medical Center - Cancer Center ( Site 0612), Stony Brook

13285

Hopital Saint Joseph ( Site 0166), Marseille

13620

Seoul National University Bundang Hospital ( Site 0464), Seongnam-si

14080

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0363), Mexico City

14642

University of Rochester ( Site 0613), Rochester

15706

Complejo Hospitalario Universitario de Santiago ( Site 0506), Santiago de Compostela

19124

Eastern Regional Medical Center, Inc. ( Site 0626), Philadelphia

20007

Georgetown University ( Site 0594), Washington D.C.

20116

Centro de Investigacion Medica Aguascalientes ( Site 0355), Aguascalientes

20246

Universitaetsklinikum Hamburg-Eppendorf ( Site 0184), Hamburg

22030

Trakya Universitesi Tip Fakultesi ( Site 0544), Edirne

25240

Erzurum Ataturk University Faculty of Medicine ( Site 0546), Erzurum

27100

Fondazione Salvatore Maugeri IRCCS. ( Site 0290), Pavia

28007

Hospital General Universitario Gregorio Maranon ( Site 0504), Madrid

28034

Hospital Universitario Ramon y Cajal ( Site 0514), Madrid

28046

Hospital Universitario La Paz ( Site 0510), Madrid

28222

Hospital Universitario Puerta de Hierro ( Site 0513), Majadahonda

30322

Emory University Winship Cancer Institute ( Site 0639), Atlanta

32804

Advent Health ( Site 0595), Orlando

33081

Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 0292), Aviano

33136

University of Miami, Sylvester Comprehensive Cancer Center ( Site 0596), Miami

33606

Tampa General Medical Group ( Site 0629), Tampa

34093

Bezmi Alem Universitesi Tıp Fakultesi ( Site 0547), Istanbul

35042

Centre Eugene Marquis ( Site 0158), Rennes

35128

Istituto Oncologico Veneto ( Site 0287), Padua

37024

Ospedale Sacro Cuore - Don Calabria ( Site 0289), Negrar

39120

Otto-Von-Guericke-Universitaet Magdeburg ( Site 0182), Magdeburg

40138

Policlinico S. Orsola-Malpighi ( Site 0286), Bologna

41013

Hospital Universitario Virgen del Rocio ( Site 0509), Seville

42080

Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0550), Konya

44280

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0365), Guadalajara

Inonu Universitesi Medical Fakultesi ( Site 0545), Malatya

45100

Centre Hospitalier Regional du Orleans ( Site 0169), Orléans

45147

Universitaetsklinikum Essen ( Site 0188), Essen

46026

Hospital Universitario y Politecnico La Fe de Valencia ( Site 0505), Valencia

50200

Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 0211), Chiang Mai

50937

Universitaetsklinik Koeln ( Site 0189), Cologne

52074

Klinikum der Universitaet Aachen - RWTH ( Site 0185), Aachen

54500

CHU de Nancy Hopital Brabois Adultes ( Site 0164), Vandœuvre-lès-Nancy

56126

Azienda Ospedaliero-Univers. Pisana Ospedale S. Chiara ( Site 0291), Pisa

59037

CHRU de Lille - Hopital Claude Huriez ( Site 0159), Lille

60596

Universitaetsklinikum Frankfurt ( Site 0180), Frankfurt am Main

66205

University of Kansas Cancer Center ( Site 0600), Westwood

68000

Oaxaca Site Management Organization S.C. ( Site 0366), Oaxaca City

69004

Hopital de la Croix Rousse ( Site 0157), Lyon

70457

National Cheng Kung University Hospital ( Site 0528), Tainan City

72076

Universitaetsklinikum Tuebingen ( Site 0179), Tübingen

72530

Unidad Medica Oncologica ( Site 0369), Puebla City

73104

University of Oklahoma Health Science Center ( Site 0625), Oklahoma City

76504

Central Texas Veterans Healthcare System ( Site 0617), Temple

84918

Institut Sainte Catherine ( Site 0167), Avignon

85721

The University of Arizona Cancer Center - North Campus ( Site 0621), Tucson

90110

Songklanagarind Hospital ( Site 0214), Hat Yai

90127

Az Osp Univ Policlin Paolo Giaccone ( Site 0284), Palermo

90404

UCLA ( Site 0589), Santa Monica

91010

City of Hope Comprehensive Cancer Center ( Site 0587), Duarte

92037

Scripps Health ( Site 0644), La Jolla

92110

Hopital Beaujon ( Site 0160), Clichy

94000

CHU Henri Mondor ( Site 0162), Créteil

94115

Pacific Hematology Oncology Associates ( Site 0588), San Francisco

97070

Medical Care and Research S.A. de C.V. ( Site 0359), Mérida

97080

Universitaetsklinikum Wuerzburg ( Site 0186), Würzburg

97239

Oregon Health & Science University ( Site 0645), Portland

99218

Cancer Care Northwest ( Site 0636), Spokane

100021

Cancer Hospital Chinese Academy of Medical Sciences ( Site 0100), Beijing

100142

Beijing Cancer Hospital ( Site 0088), Beijing

110221

Administradora Country SA - Clinica del Country ( Site 0146), Bogotá

111511

Instituto Nacional de Cancerologia E.S.E ( Site 0142), Bogotá

115478

N.N. Blokhin NMRCO ( Site 0439), Moscow

119881

First Moscow State Medical University n.a. I.M.Sechenov ( Site 0453), Moscow

195271

Railway Hospital of OJSC ( Site 0447), Saint Petersburg

198255

City Clinical Oncology Center ( Site 0446), Saint Petersburg

200032

Fudan University Shanghai Cancer Center ( Site 0086), Shanghai

Zhongshan Hospital Fudan University ( Site 0096), Shanghai

210031

The 81st Hospital of PLA ( Site 0085), Nanjing

230088

First Affiliated Hospital of Anhui Medical University ( Site 0095), Hefei

310003

The First Affiliated Hospital of Zhejiang University ( Site 0097), Hangzhou

310016

Sir Run Run Shaw Hospital ( Site 0110), Hangzhou

310022

Zhejiang Cancer Hospital ( Site 0101), Hangzhou

350025

900 Hospital of the Joint ( Site 0091), Fuzhou

357502

Pyatigorsk Oncology Dispensary ( Site 0441), Pyatigorsk

410006

Hunan Cancer Hospital ( Site 0094), Changsha

410013

The Third Xiangya Hospital of Central South University ( Site 0093), Changsha

430022

Wuhan Union hospital Cancer Center ( Site 0105), Wuhan

500515

Hospital General de Medellin Luz Castro de Gutierrez ( Site 0137), Medellín

510080

Guangdong General Hospital ( Site 0092), Guangzhou

510515

Southern Medical University Nanfang Hospital ( Site 0102), Guangzhou

610000

Harbin Medical University Cancer Hospital ( Site 0089), Harbin

West China Hospital of Sichuan University ( Site 0087), Chengdu

660133

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0450), Krasnoyarsk

710061

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0090), Xi’an

760032

Fundacion Valle del Lili ( Site 0140), Santiago de Cali

760042

Centro Medico Imbanaco de Cali S.A ( Site 0139), Santiago de Cali

830001

Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0109), Ürümqi

3465584

Clinica Universidad Catolica del Maule ( Site 0065), Talca

4810469

Instituto Clinico Oncologico del Sur ( Site 0067), Temuco

7500921

Fundacion Arturo Lopez Perez ( Site 0064), Santiago

8330024

Pontificia Universidad Catolica de Chile ( Site 0070), Santiago

02114

Massachusetts General Hospital ( Site 0603), Boston

02215

Beth Israel Deaconess Medical Center ( Site 0716), Boston

V5Z 4E6

BC Cancer-Vancouver Center ( Site 0056), Vancouver

N6A 5A5

London Health Sciences Centre ( Site 0053), London

M4N 3M5

Sunnybrook Research Institute ( Site 0055), Toronto

M5G 2M9

Princess Margaret Cancer Centre ( Site 0050), Toronto

H4A 3J1

McGill University Health Centre ( Site 0052), Montreal

050021

Fundacion Centro de Investigacion Clinica CIC ( Site 0141), Medellín

050034

Hospital Pablo Tobon Uribe ( Site 0144), Medellín

080002

Biomelab S A S ( Site 0145), Barranquilla

01307

Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0178), Dresden

04103

Universitaetsklinikum Leipzig ( Site 0187), Leipzig

D04 T6F4

St Vincents University Hospital ( Site 0242), Dublin

D07 R2WY

Mater Misericordiae University Hospital ( Site 0241), Dublin

00128

Policlinico Universitario Campus Biomedico ( Site 0288), Roma

464-8681

Aichi Cancer Center Hospital ( Site 0316), Nagoya

277-8577

National Cancer Center Hospital East ( Site 0306), Kashiwa

830-0011

Kurume University Hospital ( Site 0322), Kurume

060-0033

Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0304), Sapporo

920-8641

Kanazawa University Hospital ( Site 0315), Kanazawa

761-0793

Kagawa University Hospital ( Site 0324), Kita-gun

760-8557

Kagawa Prefectural Central Hospital ( Site 0325), Takamatsu

213-8587

Toranomon Hospital Kajigaya ( Site 0312), Kawasaki

232-0024

Yokohama City University Medical Center ( Site 0313), Yokohama

241-8515

Kanagawa Cancer Center ( Site 0314), Yokohama

589-8511

Kindai University Hospital ( Site 0319), Sayama

181-8611

Kyorin University Hospital ( Site 0309), Mitaka

180-8610

Musashino Red Cross Hospital ( Site 0310), Musashino

260-8677

Chiba University Hospital ( Site 0305), Chiba

810-8563

National Hospital Organization Kyushu Medical Center ( Site 0321), Fukuoka

734-8551

Hiroshima University Hospital ( Site 0320), Hiroshima

543-8555

Osaka Red Cross Hospital ( Site 0317), Osaka

840-8571

Saga-Ken Medical Centre Koseikan ( Site 0323), Saga

104-0045

National Cancer Center Hospital ( Site 0307), Tokyo

105-8470

Toranomon Hospital ( Site 0311), Tokyo

113-8655

The University of Tokyo Hospital ( Site 0308), Tokyo

641-8510

Wakayama Medical University Hospital ( Site 0318), Wakayama

06100

CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 0362), Mexico City

Hacettepe Uni. Tip Fakultesi ( Site 0553), Ankara

41-902

Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 0419), Bytom

75-581

Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0421), Koszalin

41-400

ID Clinic ( Site 0431), Mysłowice

64-920

Ars Medical Sp. z o.o. ( Site 0433), Piła

02-034

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0418), Warsaw

02-106

MTZ Clinical Research Sp. z o. o. ( Site 0427), Warsaw

03080

Seoul National University Hospital ( Site 0462), Seoul

03722

Yonsei University Severance Hospital ( Site 0463), Seoul

05505

Asan Medical Center ( Site 0460), Seoul

06351

Samsung Medical Center ( Site 0461), Seoul

08035

Hospital Universitari Vall d Hebron ( Site 0508), Barcelona

01250

Adana Sehir Hastanesi ( Site 0549), Adana

06200

Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0551), Ankara

07070

Akdeniz Universitesi Tip Fakultesi ( Site 0548), Antalya

NW3 2QG

Royal Free London NHS Foundation Trust ( Site 0567), London

SE5 9RS

Kings College Hospital NHS Foundation Trust ( Site 0565), London

CH63 4JY

The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0573), Birkenhead

G12 0YN

The Beatson West of Scotland Cancer Centre ( Site 0566), Glasgow

M20 4BX

The Christie NHS Foundation Trust ( Site 0575), Manchester

NG5 1PB

Nottingham University Hospitals NHS Trust ( Site 0569), Nottingham

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03713593 - Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002) | Biotech Hunter | Biotech Hunter