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ACTIVE NOT RECRUITING
NCT04246177
PHASE3

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).

Official title: A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2020-05-22

Completion Date

2026-03-25

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DRUG

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.

BIOLOGICAL

Pembrolizumab

Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).

DRUG

Oral Placebo

Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.

DRUG

IV Placebo

Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).

PROCEDURE

TACE

Conducted as a background procedure of chemotherapeutic and embolic agent(s).

Locations (205)

Arizona Oncology Associates PC- HOPE ( Site 0770)

Tucson, Arizona, United States

Scripps Clinic Torrey Pines ( Site 0714)

La Jolla, California, United States

USC Norris Comprehensive Cancer Center ( Site 0717)

Los Angeles, California, United States

UCLA Hematology/Oncology - Santa Monica ( Site 0720)

Los Angeles, California, United States

UC Irvine Health ( Site 0718)

Orange, California, United States

Yale Cancer Center ( Site 0724)

New Haven, Connecticut, United States

Tampa General Hospital ( Site 0764)

Tampa, Florida, United States

Mountain States Tumor Institute ( Site 0773)

Boise, Idaho, United States

University of Iowa Hospital and Clinics ( Site 0729)

Iowa City, Iowa, United States

University of Kansas Cancer Center ( Site 0731)

Westwood, Kansas, United States

University of Louisville ( Site 0757)

Louisville, Kentucky, United States

Tulane Medical Center ( Site 0787)

New Orleans, Louisiana, United States

University Medical Center New Orleans ( Site 0733)

New Orleans, Louisiana, United States

Henry Ford Hospital-GI/Hepatology Research ( Site 0735)

Detroit, Michigan, United States

Saint Louis University ( Site 0769)

St Louis, Missouri, United States

University of New Mexico Comprehensive Cancer Center ( Site 0805)

Albuquerque, New Mexico, United States

Monter Cancer Center ( Site 0780)

Lake Success, New York, United States

Icahn School of Medicine at Mount Sinai ( Site 0744)

New York, New York, United States

Wake Forest Baptist Health ( Site 0741)

Winston-Salem, North Carolina, United States

University of Cincinnati Medical Center ( Site 0791)

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Center ( Site 0759)

Columbus, Ohio, United States

ProMedica Flower Hospital ( Site 0796)

Sylvania, Ohio, United States

Stephenson Cancer Center ( Site 0745)

Oklahoma City, Oklahoma, United States

OHSU Center for Health & Healing ( Site 0746)

Portland, Oregon, United States

Penn State Hershey Medical Center ( Site 0766)

Hershey, Pennsylvania, United States

Houston Methodist Research Institute ( Site 0784)

Houston, Texas, United States

Edwards Comprehensive Cancer Center ( Site 0786)

Huntington, West Virginia, United States

St George Hospital ( Site 0005)

Kogarah, New South Wales, Australia

Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)

Westmead, New South Wales, Australia

Princess Alexandra Hospital ( Site 0006)

Brisbane, Queensland, Australia

Austin Health ( Site 0008)

Heidelberg, Victoria, Australia

Alfred Health ( Site 0004)

Melbourne, Victoria, Australia

Royal Perth Hospital ( Site 0002)

Perth, Western Australia, Australia

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057)

Natal, Rio Grande do Norte, Brazil

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056)

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Oncologia Reichow ( Site 0052)

Blumenau, Santa Catarina, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)

Barretos, São Paulo, Brazil

Fundacao Dr Amaral Carvalho ( Site 0050)

Jaú, São Paulo, Brazil

Hospital de Base de Sao Jose de Rio Preto ( Site 0043)

São José do Rio Preto, São Paulo, Brazil

BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)

São Paulo, São Paulo, Brazil

A.C. Camargo Cancer Center ( Site 0054)

São Paulo, Brazil

Centro de Oncología de Precisión-Oncology ( Site 0068)

Santiago, Region M. de Santiago, Chile

Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0066)

Santiago, Region M. de Santiago, Chile

Centro Investigación del Cáncer James Lind ( Site 0064)

Temuco, Región de la Araucanía, Chile

Anhui Provincial Hospital ( Site 0092)

Heifei, Anhui, China

Beijing Cancer Hospital ( Site 0099)

Beijing, Beijing Municipality, China

Beijing Cancer Hospital ( Site 0105)

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital ( Site 0087)

Beijing, Beijing Municipality, China

Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)

Chongqing, Chongqing Municipality, China

Chongqing University Three Gorges Hospital ( Site 0859)

Chongqing, Chongqing Municipality, China

Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)

Fuzhou, Fujian, China

Fujian Provincial Cancer Hospital ( Site 0085)

Fuzhou, Fujian, China

The First Affiliated Hospital of Fujian Medical University ( Site 0089)

Fuzhou, Fujian, China

Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)

Xiamen, Fujian, China

Zhujiang Hospital of Southern Medical University ( Site 0115)

Guangzhou, Guangdong, China

Guangdong Provincial People s Hospital ( Site 0100)

Guangzhou, Guangdong, China

NANFANG HOSPITAL SOUTHERN MEDICAL UNIVERSITY ( Site 0088)

Guangzhou, Guangdong, China

SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0128)

Guangzhou, Guangdong, China

Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)

Zhuhai, Guangdong, China

Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)

Nanning, Guangxi, China

Hainan General Hospital ( Site 0112)

Haikou, Hainan, China

Harbin Medical University Cancer Hospital ( Site 0090)

Harbin, Heilongjiang, China

Henan Cancer Hospital ( Site 0114)

Zhengzhou, Henan, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)

Wuhan, Hubei, China

Hubei Cancer Hospital ( Site 0101)

Wuhan, Hubei, China

Hunan Provincial People's Hospital ( Site 0113)

Changsha, Hunan, China

Hunan Cancer Hospital ( Site 0096)

Changsha, Hunan, China

The First Affiliated Hospital of Soochow University ( Site 0120)

Suzhou, Jiangsu, China

Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)

Nanchang, Jiangxi, China

Xi'an International Medical Center Hospital ( Site 0860)

Xi'an, Shaanxi, China

The Third Affiliated Hospital of the PLA Navy Medical University ( Site 0123)

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center ( Site 0106)

Shanghai, Shanghai Municipality, China

Zhongshan Hospital Fudan University ( Site 0084)

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)

Xi’an, Shanxi, China

West China Hospital of Sichuan University ( Site 0119)

Chengdu, Sichuan, China

Suining Central Hospital ( Site 0857)

Suining, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital ( Site 0098)

Tianjin, Tianjin Municipality, China

Tianjin Third Central Hospital ( Site 0861)

Tianjin, Tianjin Municipality, China

The First Hospital of Kunming ( Site 0124)

Kunming, Yunnan, China

2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital ( Site 0094)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 0103)

Hangzhou, Zhejiang, China

Ningbo Medical Center LiHuili Hospital ( Site 0132)

Ningbo, Zhejiang, China

Hospital Pablo Tobon Uribe ( Site 0145)

Medellín, Antioquia, Colombia

Administradora Country S.A. ( Site 0137)

Bogotá, Bogota D.C., Colombia

Fundacion Cardiovascular de Colombia ( Site 0136)

Piedecuesta, Santander Department, Colombia

Fundación Valle del Lili ( Site 0140)

Cali, Valle del Cauca Department, Colombia

Herlev Hospital ( Site 0170)

Herlev, Capital Region, Denmark

Aarhus Universitets hospital ( Site 0175)

Aarhus N, Central Jutland, Denmark

Odense Universitetshospital ( Site 0160)

Odense, Region Syddanmark, Denmark

Hopital de la Croix-Rousse ( Site 0193)

Lyon, Auvergne, France

Hopital de la Timone ( Site 0188)

Marseille, Bouches-du-Rhone, France

CHU Bordeaux Haut-Leveque ( Site 0185)

Pessac, Gironde, France

C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

A.P.H. Paris, Hopital Henri Mondor ( Site 0179)

Créteil, Val-de-Marne, France

Hopital Paul Brousse ( Site 0182)

Villejuif, Val-de-Marne, France

Universitaetsklinikum Freiburg ( Site 0199)

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Krankenhaus Nord-West GmbH ( Site 0208)

Frankfurt am Main, Hesse, Germany

Medizinische Hochschule Hannover ( Site 0200)

Hanover, Lower Saxony, Germany

Universitaetsklinikum Bonn ( Site 0203)

Bonn, North Rhine-Westphalia, Germany

Universitaetsklinikum Leipzig ( Site 0202)

Leipzig, Saxony, Germany

Universitaetsklinikum Halle ( Site 0213)

Halle, Saxony-Anhalt, Germany

Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)

Lübeck, Schleswig-Holstein, Germany

Charite - Universitaetsmedizin ( Site 0204)

Berlin, Germany

Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)

Hamburg, Germany

Prince of Wales Hospital ( Site 0242)

Shatin, Hong Kong

Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)

Kaposvár, Somogy County, Hungary

Zala Megyei Szent Rafael Korhaz ( Site 0265)

Zalaegerszeg, Zala County, Hungary

Semmelweis University ( Site 0264)

Budapest, Hungary

St Vincents University Hospital ( Site 0690)

Dublin, Ireland

Emek Medical Center ( Site 0307)

Afula, Israel

Rambam Health Care Campus-Oncology Division ( Site 0305)

Haifa, Israel

Hadassah Ein Karem Jerusalem ( Site 0303)

Jerusaelm, Israel

Rabin Medical Center ( Site 0304)

Petah Tikva, Israel

Sourasky Medical Center ( Site 0306)

Tel Aviv, Israel

Ospedale del Mare ( Site 0327)

Naples, Campania, Italy

ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)

Milan, Milano, Italy

Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)

Turin, Piedmont, Italy

AOU Policlinico G. Martino ( Site 0324)

Messina, Sicily, Italy

Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)

Brescia, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)

Milan, Italy

Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)

Naples, Italy

Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)

Ravenna, Italy

Policlinico Universitario -Agostino Gemelli ( Site 0328)

Roma, Italy

National Cancer Center Hospital East ( Site 0347)

Kashiwa, Chiba, Japan

Ehime University Hospital ( Site 0368)

Tōon, Ehime, Japan

Kurume University Hospital ( Site 0362)

Kurume, Fukuoka, Japan

Sapporo Kosei General Hospital ( Site 0345)

Sapporo, Hokkaido, Japan

Kanazawa University Hospital ( Site 0354)

Kanazawa, Ishikawa-ken, Japan

Kagawa Prefectural Central Hospital ( Site 0364)

Takamatsu, Kagawa-ken, Japan

Toranomon Hospital Kajigaya ( Site 0369)

Kawasaki, Kanagawa, Japan

Yokohama City University Medical Center ( Site 0351)

Yokohama, Kanagawa, Japan

Kanagawa Cancer Center ( Site 0352)

Yokohama, Kanagawa, Japan

Nara Medical University Hospital ( Site 0359)

Kashihara, Nara, Japan

Kindai University Hospital ( Site 0358)

Sayama, Osaka, Japan

Saitama Medical University Hospital ( Site 0370)

Iruma-gun, Saitama, Japan

Shizuoka Cancer Center ( Site 0365)

Suntogun, Shizuoka, Japan

Jichi Medical University Hospital ( Site 0353)

Shimotsuke, Tochigi, Japan

Chiba University Hospital ( Site 0346)

Chiba, Japan

National Hospital Organization Kyushu Medical Center ( Site 0361)

Fukuoka, Japan

Hiroshima University Hospital ( Site 0360)

Hiroshima, Japan

Kumamoto University Hospital ( Site 0372)

Kumamoto, Japan

University Hospital,Kyoto Prefectural University of Medicine ( Site 0367)

Kyoto, Japan

Osaka International Cancer Institute ( Site 0357)

Osaka, Japan

Japanese Red Cross Osaka Hospital ( Site 0356)

Osaka, Japan

Saga-Ken Medical Centre Koseikan ( Site 0363)

Saga, Japan

Toranomon Hospital ( Site 0349)

Tokyo, Japan

Juntendo University Hospital ( Site 0371)

Tokyo, Japan

The University of Tokyo Hospital ( Site 0348)

Tokyo, Japan

Maastricht University Medical Centre ( Site 0440)

Maastricht, Limburg, Netherlands

AMC ( Site 0438)

Amsterdam, North Holland, Netherlands

Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)

Leiden, South Holland, Netherlands

Erasmus University Medical Center ( Site 0439)

Rotterdam, South Holland, Netherlands

Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)

Utrecht, Netherlands

Auckland City Hospital ( Site 0459)

Auckland, New Zealand

Oslo Universitetssykehus Ullevål ( Site 0500)

Oslo, Norway

Centro Hospitalar e Universitario de Coimbra ( Site 0502)

Coimbra, Portugal

Unidade Local de Saude de São José - Hospital de Santo Antonio dos Capuchos ( Site 0505)

Lisbon, Portugal

Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)

Porto, Portugal

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)

Porto, Portugal

Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)

Porto, Portugal

Puerto Rico Medical Research Center LLC ( Site 0523)

Hato Rey, Puerto Rico

Ad-Vance Medical Research LLC ( Site 0527)

Ponce, Puerto Rico

VA Caribbean Healthcare System ( Site 0524)

San Juan, Puerto Rico

FDI Clinical Research ( Site 0522)

San Juan, Puerto Rico

Chonnam National University Hwasun Hospital ( Site 0572)

Hwasun, Jeonranamdo, South Korea

Seoul National University Bundang Hospital ( Site 0570)

Seongnam-si, Kyonggi-do, South Korea

Pusan National University Hospital ( Site 0568)

Busan, Pusan-Kwangyokshi, South Korea

Kyungpook National University Hospital ( Site 0569)

Daegu, Taegu-Kwangyokshi, South Korea

Seoul National University Hospital ( Site 0567)

Seoul, South Korea

Severance Hospital Yonsei University Health System ( Site 0564)

Seoul, South Korea

Asan Medical Center ( Site 0565)

Seoul, South Korea

Samsung Medical Center ( Site 0566)

Seoul, South Korea

The Catholic University of Korea St. Mary s Hospital ( Site 0571)

Seoul, South Korea

Korea University Guro Hospital ( Site 0573)

Seoul, South Korea

Hospital Universitario Puerta de Hierro ( Site 0596)

Majadahonda, Madrid, Spain

Hospital General Universitario de Valencia ( Site 0595)

Valencia, Valenciana, Comunitat, Spain

Hospital General Universitario Gregorio Maranon ( Site 0598)

Madrid, Spain

Hospital Ramon y Cajal ( Site 0593)

Madrid, Spain

Hospital Clinico San Carlos ( Site 0597)

Madrid, Spain

Hospital Virgen del Rocio ( Site 0591)

Seville, Spain

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)

Kaohsiung City, Kaohsiung, Taiwan

Kaohsiung Medical University Hospital ( Site 0611)

Kaohsiung City, Taiwan

China Medical University Hospital-Surgical Department ( Site 0610)

Taichung, Taiwan

Taichung Veterans General Hospital ( Site 0613)

Taichung, Taiwan

National Cheng Kung University Hospital ( Site 0608)

Tainan, Taiwan

National Taiwan University Hospital ( Site 0606)

Taipei, Taiwan

Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine ( Site 0612)

Taipei, Taiwan

Chang Gung Medical Foundation. Linkou ( Site 0607)

Taoyuan District, Taiwan

Chulalongkorn University ( Site 0627)

Bangkok, Bangkok, Thailand

Ramathibodi Hospital, Mahidol University ( Site 0628)

Bangkok, Bangkok, Thailand

Faculty of Medicine Siriraj Hospital ( Site 0629)

Bangkok, Bangkok, Thailand

Hacettepe University Medical Faculty ( Site 0653)

Ankara, Turkey (Türkiye)

Ankara City Hospital-Medical Oncology ( Site 0661)

Ankara, Turkey (Türkiye)

Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)

Edirne, Turkey (Türkiye)

Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)

Istanbul, Turkey (Türkiye)

Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)

Izmir, Turkey (Türkiye)

I.E.U. Medical Point Hastanesi ( Site 0649)

Izmir, Turkey (Türkiye)

Konya Necmettin Erbakan University Medical Faculty ( Site 0652)

Konya, Turkey (Türkiye)

Inonu Universitesi Medical Fakultesi ( Site 0650)

Malatya, Turkey (Türkiye)

Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Barts Health NHS Trust ( Site 0692)

London, London, City of, United Kingdom

Royal Marsden NHS Foundation Trust ( Site 0694)

London, London, City of, United Kingdom

Royal Marsden NHS Trust ( Site 0693)

Sutton, London, City of, United Kingdom