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)

NCT03713593 | Completed Phase 3 Results DMC FDA Drug

• 6 other identifiers: 7902-002MK-7902-002E7080-G000-311LEAP-0021945902018-002983-26
• Study Type: interventional
• Target: 794
• Locations: 21 countries
• Sites: 172

Brief 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. 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).

Conditions

Carcinoma, Hepatocellular

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)

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 41 months

• Overall Survival (OS)

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

  Up to approximately 41 months

Secondary Outcomes (14)

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

  Up to approximately 41 months

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

  Up to approximately 41 months

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

  Up to approximately 41 months

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

  Up to approximately 41 months

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

  Up to approximately 41 months

Study Arms (2)

lenvatinib plus pembrolizumab

EXPERIMENTAL

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.

Drug: lenvatinib; Biological: pembrolizumab

lenvatinib plus placebo

ACTIVE COMPARATOR

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.

Drug: lenvatinib; Drug: saline placebo

Interventions

lenvatinib DRUG

Administered orally once a day

Also known as: MK-7902, E7080, LENVIMA®

lenvatinib plus pembrolizumab; lenvatinib plus placebo

pembrolizumab BIOLOGICAL

Administered as an IV infusion on Day 1 Q3W

Also known as: MK-3475, KEYTRUDA®

lenvatinib plus pembrolizumab

saline placebo DRUG

Administered as an IV infusion on Day 1 Q3W

lenvatinib plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eisai Inc.: collaborator
• Merck Sharp & Dohme LLC: lead

Study Sites (172)

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

Tucson, Arizona, 85721, United States

Location

City of Hope Comprehensive Cancer Center ( Site 0587)

Duarte, California, 91010, United States

Location

Scripps Health ( Site 0644)

La Jolla, California, 92037, United States

Location

Pacific Hematology Oncology Associates ( Site 0588)

San Francisco, California, 94115, United States

Location

UCLA ( Site 0589)

Santa Monica, California, 90404, United States

Location

Georgetown University ( Site 0594)

Washington D.C., District of Columbia, 20007, United States

Location

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

Miami, Florida, 33136, United States

Location

Advent Health ( Site 0595)

Orlando, Florida, 32804, United States

Location

Tampa General Medical Group ( Site 0629)

Tampa, Florida, 33606, United States

Location

Emory University Winship Cancer Institute ( Site 0639)

Atlanta, Georgia, 30322, United States

Location

University of Kansas Cancer Center ( Site 0600)

Westwood, Kansas, 66205, United States

Location

Massachusetts General Hospital ( Site 0603)

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center ( Site 0716)

Boston, Massachusetts, 02215, United States

Location

Icahn School of Medicine at Mount Sinai ( Site 0611)

New York, New York, 10029, United States

Location

University of Rochester ( Site 0613)

Rochester, New York, 14642, United States

Location

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

Stony Brook, New York, 11794, United States

Location

University of Oklahoma Health Science Center ( Site 0625)

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health & Science University ( Site 0645)

Portland, Oregon, 97239, United States

Location

Eastern Regional Medical Center, Inc. ( Site 0626)

Philadelphia, Pennsylvania, 19124, United States

Location

Central Texas Veterans Healthcare System ( Site 0617)

Temple, Texas, 76504, United States

Location

Cancer Care Northwest ( Site 0636)

Spokane, Washington, 99218, United States

Location

Royal Prince Alfred Hospital ( Site 0001)

Camperdown, New South Wales, 2050, Australia

Location

Princess Alexandra Hospital ( Site 0007)

Wooloongabba, Queensland, 4102, Australia

Location

Monash Health-Monash Medical Centre ( Site 0004)

Clayton, Victoria, 3168, Australia

Location

St Vincents Hospital Melbourne ( Site 0003)

Fitzroy, Victoria, 3065, Australia

Location

Liverpool Hospital. ( Site 0002)

Liverpool, 2170, Australia

Location

BC Cancer-Vancouver Center ( Site 0056)

Vancouver, British Columbia, V5Z 4E6, Canada

Location

London Health Sciences Centre ( Site 0053)

London, Ontario, N6A 5A5, Canada

Location

Sunnybrook Research Institute ( Site 0055)

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre ( Site 0050)

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Centre ( Site 0052)

Montreal, Quebec, H4A 3J1, Canada

Location

Clinica Universidad Catolica del Maule ( Site 0065)

Talca, Maule Region, 3465584, Chile

Location

Fundacion Arturo Lopez Perez ( Site 0064)

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Pontificia Universidad Catolica de Chile ( Site 0070)

Santiago, Santiago Metropolitan, 8330024, Chile

Location

Instituto Clinico Oncologico del Sur ( Site 0067)

Temuco, 4810469, Chile

Location

First Affiliated Hospital of Anhui Medical University ( Site 0095)

Hefei, Anhui, 230088, China

Location

Cancer Hospital Chinese Academy of Medical Sciences ( Site 0100)

Beijing, Beijing Municipality, 100021, China

Location

Beijing Cancer Hospital ( Site 0088)

Beijing, Beijing Municipality, 100142, China

Location

900 Hospital of the Joint ( Site 0091)

Fuzhou, Fujian, 350025, China

Location

Guangdong General Hospital ( Site 0092)

Guangzhou, Guangdong, 510080, China

Location

Southern Medical University Nanfang Hospital ( Site 0102)

Guangzhou, Guangdong, 510515, China

Location

Harbin Medical University Cancer Hospital ( Site 0089)

Harbin, Heilongjiang, 610000, China

Location

Wuhan Union hospital Cancer Center ( Site 0105)

Wuhan, Hubei, 430022, China

Location

Hunan Cancer Hospital ( Site 0094)

Changsha, Hunan, 410006, China

Location

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

Changsha, Hunan, 410013, China

Location

The 81st Hospital of PLA ( Site 0085)

Nanjing, Jiangsu, 210031, China

Location

Fudan University Shanghai Cancer Center ( Site 0086)

Shanghai, Shanghai Municipality, 200032, China

Location

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

Xi’an, Shanxi, 710061, China

Location

West China Hospital of Sichuan University ( Site 0087)

Chengdu, Sichuan, 610000, China

Location

Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0109)

Ürümqi, Xinjiang, 830001, China

Location

The First Affiliated Hospital of Zhejiang University ( Site 0097)

Hangzhou, Zhejiang, 310003, China

Location

Sir Run Run Shaw Hospital ( Site 0110)

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital ( Site 0101)

Hangzhou, Zhejiang, 310022, China

Location

Zhongshan Hospital Fudan University ( Site 0096)

Shanghai, 200032, China

Location

Fundacion Centro de Investigacion Clinica CIC ( Site 0141)

Medellín, Antioquia, 050021, Colombia

Location

Hospital Pablo Tobon Uribe ( Site 0144)

Medellín, Antioquia, 050034, Colombia

Location

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

Medellín, Antioquia, 500515, Colombia

Location

Biomelab S A S ( Site 0145)

Barranquilla, Atlántico, 080002, Colombia

Location

Administradora Country SA - Clinica del Country ( Site 0146)

Bogotá, Bogota D.C., 110221, Colombia

Location

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

Bogotá, Bogota D.C., 111511, Colombia

Location

Fundacion Valle del Lili ( Site 0140)

Cali, Valle del Cauca Department, 760032, Colombia

Location

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

Cali, Valle del Cauca Department, 760042, Colombia

Location

Institut Sainte Catherine ( Site 0167)

Avignon, 84918, France

Location

Hopital Beaujon ( Site 0160)

Clichy, 92110, France

Location

CHU Henri Mondor ( Site 0162)

Créteil, 94000, France

Location

CHRU de Lille - Hopital Claude Huriez ( Site 0159)

Lille, 59037, France

Location

Hopital de la Croix Rousse ( Site 0157)

Lyon, 69004, France

Location

Hopital Saint Joseph ( Site 0166)

Marseille, 13285, France

Location

Centre Hospitalier Regional du Orleans ( Site 0169)

Orléans, 45100, France

Location

Centre Eugene Marquis ( Site 0158)

Rennes, 35042, France

Location

CHU de Nancy Hopital Brabois Adultes ( Site 0164)

Vandœuvre-lès-Nancy, 54500, France

Location

Klinikum der Universitaet Aachen - RWTH ( Site 0185)

Aachen, 52074, Germany

Location

Universitaetsklinik Koeln ( Site 0189)

Cologne, 50937, Germany

Location

Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0178)

Dresden, 01307, Germany

Location

Universitaetsklinikum Essen ( Site 0188)

Essen, 45147, Germany

Location

Universitaetsklinikum Frankfurt ( Site 0180)

Frankfurt am Main, 60596, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf ( Site 0184)

Hamburg, 20246, Germany

Location

Universitaetsklinikum Leipzig ( Site 0187)

Leipzig, 04103, Germany

Location

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

Magdeburg, 39120, Germany

Location

Universitaetsklinikum Tuebingen ( Site 0179)

Tübingen, 72076, Germany

Location

Universitaetsklinikum Wuerzburg ( Site 0186)

Würzburg, 97080, Germany

Location

St Vincents University Hospital ( Site 0242)

Dublin, D04 T6F4, Ireland

Location

Mater Misericordiae University Hospital ( Site 0241)

Dublin, D07 R2WY, Ireland

Location

Ospedale Sacro Cuore - Don Calabria ( Site 0289)

Negrar, VR, 37024, Italy

Location

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

Aviano, 33081, Italy

Location

Policlinico S. Orsola-Malpighi ( Site 0286)

Bologna, 40138, Italy

Location

Istituto Oncologico Veneto ( Site 0287)

Padua, 35128, Italy

Location

Az Osp Univ Policlin Paolo Giaccone ( Site 0284)

Palermo, 90127, Italy

Location

Fondazione Salvatore Maugeri IRCCS. ( Site 0290)

Pavia, 27100, Italy

Location

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

Pisa, 56126, Italy

Location

Policlinico Universitario Campus Biomedico ( Site 0288)

Roma, 00128, Italy

Location

Aichi Cancer Center Hospital ( Site 0316)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East ( Site 0306)

Kashiwa, Chiba, 277-8577, Japan

Location

Kurume University Hospital ( Site 0322)

Kurume, Fukuoka, 830-0011, Japan

Location

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

Sapporo, Hokkaido, 060-0033, Japan

Location

Kanazawa University Hospital ( Site 0315)

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kagawa University Hospital ( Site 0324)

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Kagawa Prefectural Central Hospital ( Site 0325)

Takamatsu, Kagawa-ken, 760-8557, Japan

Location

Toranomon Hospital Kajigaya ( Site 0312)

Kawasaki, Kanagawa, 213-8587, Japan

Location

Yokohama City University Medical Center ( Site 0313)

Yokohama, Kanagawa, 232-0024, Japan

Location

Kanagawa Cancer Center ( Site 0314)

Yokohama, Kanagawa, 241-8515, Japan

Location

Kindai University Hospital ( Site 0319)

Sayama, Osaka, 589-8511, Japan

Location

Kyorin University Hospital ( Site 0309)

Mitaka, Tokyo, 181-8611, Japan

Location

Musashino Red Cross Hospital ( Site 0310)

Musashino, Tokyo, 180-8610, Japan

Location

Chiba University Hospital ( Site 0305)

Chiba, 260-8677, Japan

Location

National Hospital Organization Kyushu Medical Center ( Site 0321)

Fukuoka, 810-8563, Japan

Location

Hiroshima University Hospital ( Site 0320)

Hiroshima, 734-8551, Japan

Location

Osaka Red Cross Hospital ( Site 0317)

Osaka, 543-8555, Japan

Location

Saga-Ken Medical Centre Koseikan ( Site 0323)

Saga, 840-8571, Japan

Location

National Cancer Center Hospital ( Site 0307)

Tokyo, 104-0045, Japan

Location

Toranomon Hospital ( Site 0311)

Tokyo, 105-8470, Japan

Location

The University of Tokyo Hospital ( Site 0308)

Tokyo, 113-8655, Japan

Location

Wakayama Medical University Hospital ( Site 0318)

Wakayama, 641-8510, Japan

Location

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0365)

Guadalajara, Jalisco, 44280, Mexico

Location

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

Mexico City, Mexico City, 14080, Mexico

Location

Centro de Investigacion Medica Aguascalientes ( Site 0355)

Aguascalientes, 20116, Mexico

Location

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

Mexico City, 06100, Mexico

Location

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

Mérida, 97070, Mexico

Location

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

Oaxaca City, 68000, Mexico

Location

Unidad Medica Oncologica ( Site 0369)

Puebla City, 72530, Mexico

Location

Auckland City Hospital ( Site 0376)

Auckland, 1023, New Zealand

Location

Christchurch Hospital ( Site 0377)

Christchurch, 8011, New Zealand

Location

Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 0419)

Bytom, Silesian Voivodeship, 41-902, Poland

Location

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

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

Location

ID Clinic ( Site 0431)

Mysłowice, 41-400, Poland

Location

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

Piła, 64-920, Poland

Location

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

Warsaw, 02-034, Poland

Location

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

Warsaw, 02-106, Poland

Location

N.N. Blokhin NMRCO ( Site 0439)

Moscow, Moscow, 115478, Russia

Location

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

Moscow, Moscow, 119881, Russia

Location

Railway Hospital of OJSC ( Site 0447)

Saint Petersburg, Sankt-Peterburg, 195271, Russia

Location

City Clinical Oncology Center ( Site 0446)

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0450)

Krasnoyarsk, 660133, Russia

Location

Pyatigorsk Oncology Dispensary ( Site 0441)

Pyatigorsk, 357502, Russia

Location

Seoul National University Bundang Hospital ( Site 0464)

Seongnam-si, Kyonggi-do, 13620, South Korea

Location

Seoul National University Hospital ( Site 0462)

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

Location

Yonsei University Severance Hospital ( Site 0463)

Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea

Location

Asan Medical Center ( Site 0460)

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Samsung Medical Center ( Site 0461)

Seoul, 06351, South Korea

Location

Hospital Universitari Vall d Hebron ( Site 0508)

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Hospital Universitario Puerta de Hierro ( Site 0513)

Majadahonda, Madrid, 28222, Spain

Location

Hospital General Universitario Gregorio Maranon ( Site 0504)

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal ( Site 0514)

Madrid, 28034, Spain

Location

Hospital Universitario La Paz ( Site 0510)

Madrid, 28046, Spain

Location

Complejo Hospitalario Universitario de Santiago ( Site 0506)

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen del Rocio ( Site 0509)

Seville, 41013, Spain

Location

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

Valencia, 46026, Spain

Location

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

Kaoshiung, 807, Taiwan

Location

China Medical University Hospital ( Site 0527)

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital ( Site 0526)

Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital ( Site 0528)

Tainan, 70457, Taiwan

Location

National Taiwan University Hospital ( Site 0523)

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital ( Site 0524)

Taipei, 112, Taiwan

Location

Chang Gung Medical Foundation. Linkou ( Site 0525)

Taoyuan District, 333, Taiwan

Location

Siriraj Hospital. Mahidol Univerisity ( Site 0213)

Bangkok Noi, Bangkok, 10700, Thailand

Location

Songklanagarind Hospital ( Site 0214)

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

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

Chiang Mai, 50200, Thailand

Location

Adana Sehir Hastanesi ( Site 0549)

Adana, 01250, Turkey (Türkiye)

Location

Hacettepe Uni. Tip Fakultesi ( Site 0553)

Ankara, 06100, Turkey (Türkiye)

Location

Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0551)

Ankara, 06200, Turkey (Türkiye)

Location

Akdeniz Universitesi Tip Fakultesi ( Site 0548)

Antalya, 07070, Turkey (Türkiye)

Location

Trakya Universitesi Tip Fakultesi ( Site 0544)

Edirne, 22030, Turkey (Türkiye)

Location

Erzurum Ataturk University Faculty of Medicine ( Site 0546)

Erzurum, 25240, Turkey (Türkiye)

Location

Bezmi Alem Universitesi Tıp Fakultesi ( Site 0547)

Istanbul, 34093, Turkey (Türkiye)

Location

Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0550)

Konya, 42080, Turkey (Türkiye)

Location

Inonu Universitesi Medical Fakultesi ( Site 0545)

Malatya, 44280, Turkey (Türkiye)

Location

Royal Free London NHS Foundation Trust ( Site 0567)

London, London, City of, NW3 2QG, United Kingdom

Location

Kings College Hospital NHS Foundation Trust ( Site 0565)

London, London, City of, SE5 9RS, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0573)

Birkenhead, CH63 4JY, United Kingdom

Location

The Beatson West of Scotland Cancer Centre ( Site 0566)

Glasgow, G12 0YN, United Kingdom

Location

The Christie NHS Foundation Trust ( Site 0575)

Manchester, M20 4BX, United Kingdom

Location

Nottingham University Hospitals NHS Trust ( Site 0569)

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38039993 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

lenvatinib; pembrolizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: December 31, 2018
• Primary Completion: June 21, 2022
• Study Completion: September 24, 2024
• Last Updated: February 5, 2026
• Results First Posted: July 24, 2023

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

ME (7); AU (5); IT (8); KR (5); NZ (2); PL (6); CL (4); CN (19); DE (10); RU (6); TU (9); JP (22); IE (2); TW (7); US (21); ES (8); TH (3); FR (9); CO (8); CA (5); GB (6)