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)
NCT ID: NCT03713593
Last Updated: 2025-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
794 participants
INTERVENTIONAL
2018-12-31
2024-09-24
Brief Summary
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The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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lenvatinib plus pembrolizumab
Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.
lenvatinib
Administered orally once a day
pembrolizumab
Administered as an IV infusion on Day 1 Q3W
lenvatinib plus placebo
Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally QD plus saline placebo by IV infusion on Day 1 Q3W. Saline placebo will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.
lenvatinib
Administered orally once a day
saline placebo
Administered as an IV infusion on Day 1 Q3W
Interventions
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lenvatinib
Administered orally once a day
pembrolizumab
Administered as an IV infusion on Day 1 Q3W
saline placebo
Administered as an IV infusion on Day 1 Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
* Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
* Has a Child-Pugh class A liver score
* Has a predicted life expectancy of \>3 months
* Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1 as confirmed by BICR
* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
* Participants with hepatitis B will be eligible as long as their virus is well controlled
Exclusion Criteria
* Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
* Has a preexisting Grade ≥3 gastrointestinal or non-gastrointestinal fistula
* Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior to the first dose of study intervention
* Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident stroke, or cardiac arrhythmia associated with hemodynamic instability
* Has had major surgery to the liver within 4 weeks prior to the first dose of study intervention
* Has had a minor surgery (ie, simple excision) within 7 days prior to the first dose of study intervention
* Has serious non-healing wound, ulcer, or bone fracture
* Has received any systemic chemotherapy for HCC or chemotherapy for any malignancy in the past 3 years
* Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, or CD137)
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exceptions of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that has undergone potentially curative therapy
* Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis as assessed by local site investigator
* Has severe hypersensitivity (≥Grade 3) to study intervention and/or any of their excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has urine protein ≥1 grams/24 hours
* Prolongation of corrected QT (QTc) interval to \>480 milliseconds (corrected by Fridericia Formula)
* Has left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO)
* Has an active infection requiring systemic therapy with the exceptions of hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Has a known history of human immunodeficiency virus (HIV) infection
* Has known active tuberculosis (Bacillus tuberculosis)
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention
* Has had an allogenic tissue/solid organ transplant
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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The University of Arizona Cancer Center - North Campus ( Site 0621)
Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center ( Site 0587)
Duarte, California, United States
Scripps Health ( Site 0644)
La Jolla, California, United States
Pacific Hematology Oncology Associates ( Site 0588)
San Francisco, California, United States
UCLA ( Site 0589)
Santa Monica, California, United States
Georgetown University ( Site 0594)
Washington D.C., District of Columbia, United States
University of Miami, Sylvester Comprehensive Cancer Center ( Site 0596)
Miami, Florida, United States
Advent Health ( Site 0595)
Orlando, Florida, United States
Tampa General Medical Group ( Site 0629)
Tampa, Florida, United States
Emory University Winship Cancer Institute ( Site 0639)
Atlanta, Georgia, United States
University of Kansas Cancer Center ( Site 0600)
Westwood, Kansas, United States
Massachusetts General Hospital ( Site 0603)
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center ( Site 0716)
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai ( Site 0611)
New York, New York, United States
University of Rochester ( Site 0613)
Rochester, New York, United States
Stony Brook University Medical Center - Cancer Center ( Site 0612)
Stony Brook, New York, United States
University of Oklahoma Health Science Center ( Site 0625)
Oklahoma City, Oklahoma, United States
Oregon Health & Science University ( Site 0645)
Portland, Oregon, United States
Eastern Regional Medical Center, Inc. ( Site 0626)
Philadelphia, Pennsylvania, United States
Central Texas Veterans Healthcare System ( Site 0617)
Temple, Texas, United States
Cancer Care Northwest ( Site 0636)
Spokane, Washington, United States
Royal Prince Alfred Hospital ( Site 0001)
Camperdown, New South Wales, Australia
Princess Alexandra Hospital ( Site 0007)
Wooloongabba, Queensland, Australia
Monash Health-Monash Medical Centre ( Site 0004)
Clayton, Victoria, Australia
St Vincents Hospital Melbourne ( Site 0003)
Fitzroy, Victoria, Australia
Liverpool Hospital. ( Site 0002)
Liverpool, , Australia
BC Cancer-Vancouver Center ( Site 0056)
Vancouver, British Columbia, Canada
London Health Sciences Centre ( Site 0053)
London, Ontario, Canada
Sunnybrook Research Institute ( Site 0055)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0050)
Toronto, Ontario, Canada
McGill University Health Centre ( Site 0052)
Montreal, Quebec, Canada
Clinica Universidad Catolica del Maule ( Site 0065)
Talca, Maule Region, Chile
Fundacion Arturo Lopez Perez ( Site 0064)
Santiago, Santiago Metropolitan, Chile
Pontificia Universidad Catolica de Chile ( Site 0070)
Santiago, Santiago Metropolitan, Chile
Instituto Clinico Oncologico del Sur ( Site 0067)
Temuco, , Chile
First Affiliated Hospital of Anhui Medical University ( Site 0095)
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 0100)
Beijing, Beijing Municipality, China
Beijing Cancer Hospital ( Site 0088)
Beijing, Beijing Municipality, China
900 Hospital of the Joint ( Site 0091)
Fuzhou, Fujian, China
Guangdong General Hospital ( Site 0092)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 0102)
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 0089)
Harbin, Heilongjiang, China
Wuhan Union hospital Cancer Center ( Site 0105)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 0094)
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University ( Site 0093)
Changsha, Hunan, China
The 81st Hospital of PLA ( Site 0085)
Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center ( Site 0086)
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0090)
Xi’an, Shanxi, China
West China Hospital of Sichuan University ( Site 0087)
Chengdu, Sichuan, China
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0109)
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Zhejiang University ( Site 0097)
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital ( Site 0110)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0101)
Hangzhou, Zhejiang, China
Zhongshan Hospital Fudan University ( Site 0096)
Shanghai, , China
Fundacion Centro de Investigacion Clinica CIC ( Site 0141)
Medellín, Antioquia, Colombia
Hospital Pablo Tobon Uribe ( Site 0144)
Medellín, Antioquia, Colombia
Hospital General de Medellin Luz Castro de Gutierrez ( Site 0137)
Medellín, Antioquia, Colombia
Biomelab S A S ( Site 0145)
Barranquilla, Atlántico, Colombia
Administradora Country SA - Clinica del Country ( Site 0146)
Bogotá, Bogota D.C., Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 0142)
Bogotá, Bogota D.C., Colombia
Fundacion Valle del Lili ( Site 0140)
Cali, Valle del Cauca Department, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0139)
Cali, Valle del Cauca Department, Colombia
Institut Sainte Catherine ( Site 0167)
Avignon, , France
Hopital Beaujon ( Site 0160)
Clichy, , France
CHU Henri Mondor ( Site 0162)
Créteil, , France
CHRU de Lille - Hopital Claude Huriez ( Site 0159)
Lille, , France
Hopital de la Croix Rousse ( Site 0157)
Lyon, , France
Hopital Saint Joseph ( Site 0166)
Marseille, , France
Centre Hospitalier Regional du Orleans ( Site 0169)
Orléans, , France
Centre Eugene Marquis ( Site 0158)
Rennes, , France
CHU de Nancy Hopital Brabois Adultes ( Site 0164)
Vandœuvre-lès-Nancy, , France
Klinikum der Universitaet Aachen - RWTH ( Site 0185)
Aachen, , Germany
Universitaetsklinik Koeln ( Site 0189)
Cologne, , Germany
Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0178)
Dresden, , Germany
Universitaetsklinikum Essen ( Site 0188)
Essen, , Germany
Universitaetsklinikum Frankfurt ( Site 0180)
Frankfurt am Main, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0184)
Hamburg, , Germany
Universitaetsklinikum Leipzig ( Site 0187)
Leipzig, , Germany
Otto-Von-Guericke-Universitaet Magdeburg ( Site 0182)
Magdeburg, , Germany
Universitaetsklinikum Tuebingen ( Site 0179)
Tübingen, , Germany
Universitaetsklinikum Wuerzburg ( Site 0186)
Würzburg, , Germany
St Vincents University Hospital ( Site 0242)
Dublin, , Ireland
Mater Misericordiae University Hospital ( Site 0241)
Dublin, , Ireland
Ospedale Sacro Cuore - Don Calabria ( Site 0289)
Negrar, VR, Italy
Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 0292)
Aviano, , Italy
Policlinico S. Orsola-Malpighi ( Site 0286)
Bologna, , Italy
Istituto Oncologico Veneto ( Site 0287)
Padua, , Italy
Az Osp Univ Policlin Paolo Giaccone ( Site 0284)
Palermo, , Italy
Fondazione Salvatore Maugeri IRCCS. ( Site 0290)
Pavia, , Italy
Azienda Ospedaliero-Univers. Pisana Ospedale S. Chiara ( Site 0291)
Pisa, , Italy
Policlinico Universitario Campus Biomedico ( Site 0288)
Roma, , Italy
Aichi Cancer Center Hospital ( Site 0316)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 0306)
Kashiwa, Chiba, Japan
Kurume University Hospital ( Site 0322)
Kurume, Fukuoka, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0304)
Sapporo, Hokkaido, Japan
Kanazawa University Hospital ( Site 0315)
Kanazawa, Ishikawa-ken, Japan
Kagawa University Hospital ( Site 0324)
Kita-gun, Kagawa-ken, Japan
Kagawa Prefectural Central Hospital ( Site 0325)
Takamatsu, Kagawa-ken, Japan
Toranomon Hospital Kajigaya ( Site 0312)
Kawasaki, Kanagawa, Japan
Yokohama City University Medical Center ( Site 0313)
Yokohama, Kanagawa, Japan
Kanagawa Cancer Center ( Site 0314)
Yokohama, Kanagawa, Japan
Kindai University Hospital ( Site 0319)
Sayama, Osaka, Japan
Kyorin University Hospital ( Site 0309)
Mitaka, Tokyo, Japan
Musashino Red Cross Hospital ( Site 0310)
Musashino, Tokyo, Japan
Chiba University Hospital ( Site 0305)
Chiba, , Japan
National Hospital Organization Kyushu Medical Center ( Site 0321)
Fukuoka, , Japan
Hiroshima University Hospital ( Site 0320)
Hiroshima, , Japan
Osaka Red Cross Hospital ( Site 0317)
Osaka, , Japan
Saga-Ken Medical Centre Koseikan ( Site 0323)
Saga, , Japan
National Cancer Center Hospital ( Site 0307)
Tokyo, , Japan
Toranomon Hospital ( Site 0311)
Tokyo, , Japan
The University of Tokyo Hospital ( Site 0308)
Tokyo, , Japan
Wakayama Medical University Hospital ( Site 0318)
Wakayama, , Japan
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0365)
Guadalajara, Jalisco, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0363)
Mexico City, Mexico City, Mexico
Centro de Investigacion Medica Aguascalientes ( Site 0355)
Aguascalientes, , Mexico
CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 0362)
Mexico City, , Mexico
Medical Care and Research S.A. de C.V. ( Site 0359)
Mérida, , Mexico
Oaxaca Site Management Organization S.C. ( Site 0366)
Oaxaca City, , Mexico
Unidad Medica Oncologica ( Site 0369)
Puebla City, , Mexico
Auckland City Hospital ( Site 0376)
Auckland, , New Zealand
Christchurch Hospital ( Site 0377)
Christchurch, , New Zealand
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 0419)
Bytom, Silesian Voivodeship, Poland
Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0421)
Koszalin, West Pomeranian Voivodeship, Poland
ID Clinic ( Site 0431)
Mysłowice, , Poland
Ars Medical Sp. z o.o. ( Site 0433)
Piła, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0418)
Warsaw, , Poland
MTZ Clinical Research Sp. z o. o. ( Site 0427)
Warsaw, , Poland
N.N. Blokhin NMRCO ( Site 0439)
Moscow, Moscow, Russia
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0453)
Moscow, Moscow, Russia
Railway Hospital of OJSC ( Site 0447)
Saint Petersburg, Sankt-Peterburg, Russia
City Clinical Oncology Center ( Site 0446)
Saint Petersburg, Sankt-Peterburg, Russia
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0450)
Krasnoyarsk, , Russia
Pyatigorsk Oncology Dispensary ( Site 0441)
Pyatigorsk, , Russia
Seoul National University Bundang Hospital ( Site 0464)
Seongnam-si, Kyonggi-do, South Korea
Seoul National University Hospital ( Site 0462)
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Yonsei University Severance Hospital ( Site 0463)
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Asan Medical Center ( Site 0460)
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center ( Site 0461)
Seoul, , South Korea
Hospital Universitari Vall d Hebron ( Site 0508)
Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario Puerta de Hierro ( Site 0513)
Majadahonda, Madrid, Spain
Hospital General Universitario Gregorio Maranon ( Site 0504)
Madrid, , Spain
Hospital Universitario Ramon y Cajal ( Site 0514)
Madrid, , Spain
Hospital Universitario La Paz ( Site 0510)
Madrid, , Spain
Complejo Hospitalario Universitario de Santiago ( Site 0506)
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio ( Site 0509)
Seville, , Spain
Hospital Universitario y Politecnico La Fe de Valencia ( Site 0505)
Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0529)
Kaoshiung, , Taiwan
China Medical University Hospital ( Site 0527)
Taichung, , Taiwan
Taichung Veterans General Hospital ( Site 0526)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 0528)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 0523)
Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 0524)
Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0525)
Taoyuan District, , Taiwan
Siriraj Hospital. Mahidol Univerisity ( Site 0213)
Bangkok Noi, Bangkok, Thailand
Songklanagarind Hospital ( Site 0214)
Hat Yai, Changwat Songkhla, Thailand
Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 0211)
Chiang Mai, , Thailand
Adana Sehir Hastanesi ( Site 0549)
Adana, , Turkey (Türkiye)
Hacettepe Uni. Tip Fakultesi ( Site 0553)
Ankara, , Turkey (Türkiye)
Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0551)
Ankara, , Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi ( Site 0548)
Antalya, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi ( Site 0544)
Edirne, , Turkey (Türkiye)
Erzurum Ataturk University Faculty of Medicine ( Site 0546)
Erzurum, , Turkey (Türkiye)
Bezmi Alem Universitesi Tıp Fakultesi ( Site 0547)
Istanbul, , Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0550)
Konya, , Turkey (Türkiye)
Inonu Universitesi Medical Fakultesi ( Site 0545)
Malatya, , Turkey (Türkiye)
Royal Free London NHS Foundation Trust ( Site 0567)
London, London, City of, United Kingdom
Kings College Hospital NHS Foundation Trust ( Site 0565)
London, London, City of, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0573)
Birkenhead, , United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 0566)
Glasgow, , United Kingdom
The Christie NHS Foundation Trust ( Site 0575)
Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust ( Site 0569)
Nottingham, , United Kingdom
Countries
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References
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Llovet JM, Kudo M, Merle P, Meyer T, Qin S, Ikeda M, Xu R, Edeline J, Ryoo BY, Ren Z, Masi G, Kwiatkowski M, Lim HY, Kim JH, Breder V, Kumada H, Cheng AL, Galle PR, Kaneko S, Wang A, Mody K, Dutcus C, Dubrovsky L, Siegel AB, Finn RS; LEAP-002 Investigators. Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma (LEAP-002): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Dec;24(12):1399-1410. doi: 10.1016/S1470-2045(23)00469-2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-7902-002
Identifier Type: OTHER
Identifier Source: secondary_id
E7080-G000-311
Identifier Type: OTHER
Identifier Source: secondary_id
LEAP-002
Identifier Type: OTHER
Identifier Source: secondary_id
194590
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-002983-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7902-002
Identifier Type: -
Identifier Source: org_study_id
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