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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
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
2026-03-26
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
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).
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 Investigación del Cáncer James Lind ( Site 0064)
Temuco, Araucania, Chile
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
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