AzTrials
AzTrials

Carcinoma, HepatocellularPhase 3NCT03713593

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)

A Phase 3 study testing lenvatinib and pembrolizumab in people with Carcinoma, Hepatocellular, run by Merck Sharp & Dohme LLC at 172 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
lenvatinib and pembrolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
794 participants
Where
172 sitesin 21 countries
Study dates
31 Dec 2018to 24 Sep 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is male or female and ≥18 years of age at the time of signing the informed consent
  • 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

Who cannot join

  • Has had esophageal or gastric variceal bleeding within the last 6 months
  • 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
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  • 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

Trial locations and contacts

172 sites in 21 countries.

172 sites in 21 countries

Japan22 sites

  • Chiba University Hospital ( Site 0305)

    Chiba, 260-8677

  • National Hospital Organization Kyushu Medical Center ( Site 0321)

    Fukuoka, 810-8563

  • Hiroshima University Hospital ( Site 0320)

    Hiroshima, 734-8551

  • Kanazawa University Hospital ( Site 0315)

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East ( Site 0306)

    Kashiwa, Chiba, 277-8577

  • Toranomon Hospital Kajigaya ( Site 0312)

    Kawasaki, Kanagawa, 213-8587

  • Kagawa University Hospital ( Site 0324)

    Kita-gun, Kagawa-ken, 761-0793

  • Kurume University Hospital ( Site 0322)

    Kurume, Fukuoka, 830-0011

  • Kyorin University Hospital ( Site 0309)

    Mitaka, Tokyo, 181-8611

  • Musashino Red Cross Hospital ( Site 0310)

    Musashino, Tokyo, 180-8610

  • Aichi Cancer Center Hospital ( Site 0316)

    Nagoya, Aichi-ken, 464-8681

  • Osaka Red Cross Hospital ( Site 0317)

    Osaka, 543-8555

  • Saga-Ken Medical Centre Koseikan ( Site 0323)

    Saga, 840-8571

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

    Sapporo, Hokkaido, 060-0033

  • Kindai University Hospital ( Site 0319)

    Sayama, Osaka, 589-8511

  • Kagawa Prefectural Central Hospital ( Site 0325)

    Takamatsu, Kagawa-ken, 760-8557

  • National Cancer Center Hospital ( Site 0307)

    Tokyo, 104-0045

  • Toranomon Hospital ( Site 0311)

    Tokyo, 105-8470

  • The University of Tokyo Hospital ( Site 0308)

    Tokyo, 113-8655

  • Wakayama Medical University Hospital ( Site 0318)

    Wakayama, 641-8510

  • Yokohama City University Medical Center ( Site 0313)

    Yokohama, Kanagawa, 232-0024

  • Kanagawa Cancer Center ( Site 0314)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United States21 sites

  • Emory University Winship Cancer Institute ( Site 0639)

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital ( Site 0603)

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center ( Site 0716)

    Boston, Massachusetts, 02215

  • City of Hope Comprehensive Cancer Center ( Site 0587)

    Duarte, California, 91010

  • Scripps Health ( Site 0644)

    La Jolla, California, 92037

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

    Miami, Florida, 33136

  • Icahn School of Medicine at Mount Sinai ( Site 0611)

    New York, New York, 10029

  • University of Oklahoma Health Science Center ( Site 0625)

    Oklahoma City, Oklahoma, 73104

  • Advent Health ( Site 0595)

    Orlando, Florida, 32804

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

    Philadelphia, Pennsylvania, 19124

  • Oregon Health & Science University ( Site 0645)

    Portland, Oregon, 97239

  • University of Rochester ( Site 0613)

    Rochester, New York, 14642

  • Pacific Hematology Oncology Associates ( Site 0588)

    San Francisco, California, 94115

  • UCLA ( Site 0589)

    Santa Monica, California, 90404

  • Cancer Care Northwest ( Site 0636)

    Spokane, Washington, 99218

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

    Stony Brook, New York, 11794

  • Tampa General Medical Group ( Site 0629)

    Tampa, Florida, 33606

  • Central Texas Veterans Healthcare System ( Site 0617)

    Temple, Texas, 76504

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

    Tucson, Arizona, 85721

  • Georgetown University ( Site 0594)

    Washington D.C., District of Columbia, 20007

  • University of Kansas Cancer Center ( Site 0600)

    Westwood, Kansas, 66205

Other trials in United States

China19 sites

  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 0100)

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital ( Site 0088)

    Beijing, Beijing Municipality, 100142

  • Hunan Cancer Hospital ( Site 0094)

    Changsha, Hunan, 410006

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

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University ( Site 0087)

    Chengdu, Sichuan, 610000

  • 900 Hospital of the Joint ( Site 0091)

    Fuzhou, Fujian, 350025

  • Guangdong General Hospital ( Site 0092)

    Guangzhou, Guangdong, 510080

  • Southern Medical University Nanfang Hospital ( Site 0102)

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital of Zhejiang University ( Site 0097)

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital ( Site 0110)

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital ( Site 0101)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital ( Site 0089)

    Harbin, Heilongjiang, 610000

  • First Affiliated Hospital of Anhui Medical University ( Site 0095)

    Hefei, Anhui, 230088

  • The 81st Hospital of PLA ( Site 0085)

    Nanjing, Jiangsu, 210031

  • Fudan University Shanghai Cancer Center ( Site 0086)

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital Fudan University ( Site 0096)

    Shanghai, 200032

  • Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0109)

    Ürümqi, Xinjiang, 830001

  • Wuhan Union hospital Cancer Center ( Site 0105)

    Wuhan, Hubei, 430022

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

    Xi’an, Shanxi, 710061

Other trials in China

Germany10 sites

  • Klinikum der Universitaet Aachen - RWTH ( Site 0185)

    Aachen, 52074

  • Universitaetsklinik Koeln ( Site 0189)

    Cologne, 50937

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

    Dresden, 01307

  • Universitaetsklinikum Essen ( Site 0188)

    Essen, 45147

  • Universitaetsklinikum Frankfurt ( Site 0180)

    Frankfurt am Main, 60596

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0184)

    Hamburg, 20246

  • Universitaetsklinikum Leipzig ( Site 0187)

    Leipzig, 04103

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

    Magdeburg, 39120

  • Universitaetsklinikum Tuebingen ( Site 0179)

    Tübingen, 72076

  • Universitaetsklinikum Wuerzburg ( Site 0186)

    Würzburg, 97080

Other trials in Germany

France9 sites

  • Institut Sainte Catherine ( Site 0167)

    Avignon, 84918

  • Hopital Beaujon ( Site 0160)

    Clichy, 92110

  • CHU Henri Mondor ( Site 0162)

    Créteil, 94000

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

    Lille, 59037

  • Hopital de la Croix Rousse ( Site 0157)

    Lyon, 69004

  • Hopital Saint Joseph ( Site 0166)

    Marseille, 13285

  • Centre Hospitalier Regional du Orleans ( Site 0169)

    Orléans, 45100

  • Centre Eugene Marquis ( Site 0158)

    Rennes, 35042

  • CHU de Nancy Hopital Brabois Adultes ( Site 0164)

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Turkey (Türkiye)9 sites

  • Adana Sehir Hastanesi ( Site 0549)

    Adana, 01250

  • Hacettepe Uni. Tip Fakultesi ( Site 0553)

    Ankara, 06100

  • Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0551)

    Ankara, 06200

  • Akdeniz Universitesi Tip Fakultesi ( Site 0548)

    Antalya, 07070

  • Trakya Universitesi Tip Fakultesi ( Site 0544)

    Edirne, 22030

  • Erzurum Ataturk University Faculty of Medicine ( Site 0546)

    Erzurum, 25240

  • Bezmi Alem Universitesi Tıp Fakultesi ( Site 0547)

    Istanbul, 34093

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0550)

    Konya, 42080

  • Inonu Universitesi Medical Fakultesi ( Site 0545)

    Malatya, 44280

Other trials in Turkey (Türkiye)

Colombia8 sites

  • Biomelab S A S ( Site 0145)

    Barranquilla, Atlántico, 080002

  • Administradora Country SA - Clinica del Country ( Site 0146)

    Bogotá, Bogota D.C., 110221

  • Instituto Nacional de Cancerologia E.S.E ( Site 0142)

    Bogotá, Bogota D.C., 111511

  • Fundacion Valle del Lili ( Site 0140)

    Cali, Valle del Cauca Department, 760032

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

    Cali, Valle del Cauca Department, 760042

  • Fundacion Centro de Investigacion Clinica CIC ( Site 0141)

    Medellín, Antioquia, 050021

  • Hospital Pablo Tobon Uribe ( Site 0144)

    Medellín, Antioquia, 050034

  • Hospital General de Medellin Luz Castro de Gutierrez ( Site 0137)

    Medellín, Antioquia, 500515

Other trials in Colombia

Italy8 sites

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

    Aviano, 33081

  • Policlinico S. Orsola-Malpighi ( Site 0286)

    Bologna, 40138

  • Ospedale Sacro Cuore - Don Calabria ( Site 0289)

    Negrar, VR, 37024

  • Istituto Oncologico Veneto ( Site 0287)

    Padova, 35128

  • Az Osp Univ Policlin Paolo Giaccone ( Site 0284)

    Palermo, 90127

  • Fondazione Salvatore Maugeri IRCCS. ( Site 0290)

    Pavia, 27100

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

    Pisa, 56126

  • Policlinico Universitario Campus Biomedico ( Site 0288)

    Roma, 00128

Other trials in Italy

Spain8 sites

  • Hospital Universitari Vall d Hebron ( Site 0508)

    Barcelona, Barcelona [Barcelona], 08035

  • Hospital General Universitario Gregorio Maranon ( Site 0504)

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal ( Site 0514)

    Madrid, 28034

  • Hospital Universitario La Paz ( Site 0510)

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro ( Site 0513)

    Majadahonda, Madrid, 28222

  • Complejo Hospitalario Universitario de Santiago ( Site 0506)

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen del Rocio ( Site 0509)

    Seville, 41013

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

    Valencia, 46026

Other trials in Spain

Mexico7 sites

  • Centro de Investigacion Medica Aguascalientes ( Site 0355)

    Aguascalientes, 20116

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

    Guadalajara, Jalisco, 44280

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

    Mérida, 97070

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0363)

    Mexico City, Mexico City, 14080

  • CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 0362)

    Mexico City, 06100

  • Oaxaca Site Management Organization S.C. ( Site 0366)

    Oaxaca City, 68000

  • Unidad Medica Oncologica ( Site 0369)

    Puebla City, 72530

Other trials in Mexico

Taiwan7 sites

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

    Kaoshiung, 807

  • China Medical University Hospital ( Site 0527)

    Taichung, 404

  • Taichung Veterans General Hospital ( Site 0526)

    Taichung, 407

  • National Cheng Kung University Hospital ( Site 0528)

    Tainan, 70457

  • National Taiwan University Hospital ( Site 0523)

    Taipei, 100

  • Taipei Veterans General Hospital ( Site 0524)

    Taipei, 112

  • Chang Gung Medical Foundation. Linkou ( Site 0525)

    Taoyuan, 333

Other trials in Taiwan

Poland6 sites

  • Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 0419)

    Bytom, Silesian Voivodeship, 41-902

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

    Koszalin, West Pomeranian Voivodeship, 75-581

  • ID Clinic ( Site 0431)

    Mysłowice, 41-400

  • Ars Medical Sp. z o.o. ( Site 0433)

    Piła, 64-920

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

    Warsaw, 02-034

  • MTZ Clinical Research Sp. z o. o. ( Site 0427)

    Warsaw, 02-106

Other trials in Poland

Russia6 sites

  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0450)

    Krasnoyarsk, 660133

  • N.N. Blokhin NMRCO ( Site 0439)

    Moscow, Moscow, 115478

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

    Moscow, Moscow, 119881

  • Pyatigorsk Oncology Dispensary ( Site 0441)

    Pyatigorsk, 357502

  • Railway Hospital of OJSC ( Site 0447)

    Saint Petersburg, Sankt-Peterburg, 195271

  • City Clinical Oncology Center ( Site 0446)

    Saint Petersburg, Sankt-Peterburg, 198255

Other trials in Russia

United Kingdom6 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0573)

    Birkenhead, CH63 4JY

  • The Beatson West of Scotland Cancer Centre ( Site 0566)

    Glasgow, G12 0YN

  • Royal Free London NHS Foundation Trust ( Site 0567)

    London, London, City of, NW3 2QG

  • Kings College Hospital NHS Foundation Trust ( Site 0565)

    London, London, City of, SE5 9RS

  • The Christie NHS Foundation Trust ( Site 0575)

    Manchester, M20 4BX

  • Nottingham University Hospitals NHS Trust ( Site 0569)

    Nottingham, NG5 1PB

Other trials in United Kingdom

Australia5 sites

  • Royal Prince Alfred Hospital ( Site 0001)

    Camperdown, New South Wales, 2050

  • Monash Health-Monash Medical Centre ( Site 0004)

    Clayton, Victoria, 3168

  • St Vincents Hospital Melbourne ( Site 0003)

    Fitzroy, Victoria, 3065

  • Liverpool Hospital. ( Site 0002)

    Liverpool, 2170

  • Princess Alexandra Hospital ( Site 0007)

    Wooloongabba, Queensland, 4102

Other trials in Australia

Canada5 sites

  • London Health Sciences Centre ( Site 0053)

    London, Ontario, N6A 5A5

  • McGill University Health Centre ( Site 0052)

    Montreal, Quebec, H4A 3J1

  • Sunnybrook Research Institute ( Site 0055)

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre ( Site 0050)

    Toronto, Ontario, M5G 2M9

  • BC Cancer-Vancouver Center ( Site 0056)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

South Korea5 sites

  • Seoul National University Bundang Hospital ( Site 0464)

    Seongnam-si, Kyonggi-do, 13620

  • Seoul National University Hospital ( Site 0462)

    Seoul, Seoul-teukbyeolsi [Seoul], 03080

  • Yonsei University Severance Hospital ( Site 0463)

    Seoul, Seoul-teukbyeolsi [Seoul], 03722

  • Asan Medical Center ( Site 0460)

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Samsung Medical Center ( Site 0461)

    Seoul, 06351

Other trials in South Korea

Chile4 sites

  • Fundacion Arturo Lopez Perez ( Site 0064)

    Santiago, Santiago Metropolitan, 7500921

  • Pontificia Universidad Catolica de Chile ( Site 0070)

    Santiago, Santiago Metropolitan, 8330024

  • Clinica Universidad Catolica del Maule ( Site 0065)

    Talca, Maule Region, 3465584

  • Instituto Clinico Oncologico del Sur ( Site 0067)

    Temuco, 4810469

Other trials in Chile

Thailand3 sites

  • Siriraj Hospital. Mahidol Univerisity ( Site 0213)

    Bangkok Noi, Bangkok, 10700

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

    Chiang Mai, 50200

  • Songklanagarind Hospital ( Site 0214)

    Hat Yai, Changwat Songkhla, 90110

Other trials in Thailand

Ireland2 sites

  • St Vincents University Hospital ( Site 0242)

    Dublin, D04 T6F4

  • Mater Misericordiae University Hospital ( Site 0241)

    Dublin, D07 R2WY

Other trials in Ireland

New Zealand2 sites

  • Auckland City Hospital ( Site 0376)

    Auckland, 1023

  • Christchurch Hospital ( Site 0377)

    Christchurch, 8011

Other trials in New Zealand

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)

The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants.

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).

Being tested
lenvatinib, pembrolizumab, saline placebo
Keywords
receptor tyrosine kinase inhibitor, programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1), programmed cell death ligand 2 (PD-L2, PDL2)
Medical subject headings
Carcinoma, Hepatocellular, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lenvatinibDrug

    Also called MK-7902, E7080, LENVIMA®

    Administered orally once a day

  • pembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    Administered as an IV infusion on Day 1 Q3W

  • saline placeboDrug

    Administered as an IV infusion on Day 1 Q3W

Study groups in NCT03713593
Study groupRoleWhat they receive
lenvatinib plus pembrolizumabExperimentalParticipants 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.
Receives: Drug: lenvatinib; Biological: pembrolizumab
lenvatinib plus placeboActive comparatorParticipants 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.
Receives: Drug: lenvatinib; Drug: saline placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    PFS was defined as the time from the date of the first documentation of disease progression, as determined by blinded independent central review (BICR) per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.

    Measured: Up to approximately 41 months

  2. Overall Survival (OS)

    OS was defined as the time from randomization until death from any cause

    Measured: Up to approximately 41 months

Secondary outcomes (14)

  1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    ORR was defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 as assessed by BICR. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

    Measured: Up to approximately 41 months

  2. Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    DOR was determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR, per RECIST 1.1 as assessed by BICR, until the first documented disease progression or death due to any cause, whichever occurred first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

    Measured: Up to approximately 41 months

  3. Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    DCR was defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per RECIST 1.1 as assessed by BICR. SD must be achieved at ≥6 weeks after randomization to be considered best overall response. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

    Measured: Up to approximately 41 months

  4. Time to Disease Progression (TTP) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR. RECIST 1.1 was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed.

    Measured: Up to approximately 41 months

  5. Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

    PFS was defined as the time from the first dose of study intervention to the first documented progressive disease (PD) per mRECIST by BICR or death due to any cause, whichever occurred first. mRECIST for HCC allowed evaluation of treatment effects that were not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the sum of diameters (SODs) of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started.

    Measured: Up to approximately 41 months

  6. Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

    ORR wass defined as the percentage of participants who have a confirmed complete response (CR: disappearance of any intratumoral arterial enhancement in all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions) per mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed.

    Measured: Up to approximately 41 months

  7. Duration of Response (DOR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

    DOR was determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR, per mRECIST as assessed by BICR, until the first documented disease progression or death due to any cause, whichever occurs first. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed.

    Measured: Up to approximately 41 months

  8. Disease Control Rate (DCR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

    DCR was defined as the percentage of participants who have a best overall response of CR, PR, or SD per mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. SD must be achieved at ≥6 weeks after randomization to be considered best overall response. A maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed.

    Measured: Up to approximately 41 months

  9. Time to Disease Progression (TTP) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

    TTP was defined as the time from randomization to the first documented disease progression per mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed.

    Measured: Up to approximately 41 months

  10. Number of Participants Who Experienced an Adverse Event (AE)

    Number of participants who experienced an AE defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study treatment

    Measured: Up to approximately 68 months

  11. Number of Participants Who Experienced an Serious Adverse Event (SAE)

    Number of participants who experienced a SAE defined as an AE that resulted in death, was life threatening, resulting in persistent or significant disability or incapacity, resulting in or prolonged a hospitalization, was a congenital anomaly or birth defect, was a cancer, was associated with an overdose, or was another important medical event

    Measured: Up to approximately 68 months

  12. Number of Participants Who Experienced an Immune-related Adverse Event (irAE) of Clinical Interest

    Number of participants who experienced an AE representing an immunologic etiology and considered to be causally related to drug exposure

    Measured: Up to approximately 41 months

  13. Number of Participants Who Experienced an Hepatic Event of Clinical Interest (HECI)

    Number of participants who experienced a hepatic ECI not due to disease progression as judged by the investigator.

    Measured: Up to approximately 68 months

  14. Number of Participants Who Discontinued Study Drug Due to an Adverse Event

    Number of participants who discontinued study treatment due to an AE

    Measured: Up to approximately 68 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2018
  2. Study start31 Dec 2018
  3. Primary completion21 Jun 2022
  4. Study completion24 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
794 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03713593
Sponsor's protocol ID
7902-002
Other IDs
MK-7902-002, E7080-G000-311, LEAP-002, 194590, 2018-002983-26, 2018
Status last verified
Dec 2025
First submitted
18 Oct 2018
Last updated
5 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 38039993

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lenvatinib and pembrolizumab in people with Carcinoma, Hepatocellular, run by Merck Sharp & Dohme LLC at 172 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in Japan, United States, China, Germany, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Up to approximately 41 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03713593, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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