Clinical trial NCT03713593: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2018-10-22
Enrollment: 794
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 41 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 41 months
Secondary outcomes:
measure: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 41 months
measure: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 41 months
measure: Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 41 months
measure: Time to Disease Progression (TTP) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 41 months
measure: Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Up to approximately 41 months
measure: Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Up to approximately 41 months
measure: Duration of Response (DOR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Up to approximately 41 months
measure: Disease Control Rate (DCR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Up to approximately 41 months
measure: Time to Disease Progression (TTP) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Up to approximately 41 months
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 41 months
measure: Number of Participants Who Experienced an Serious Adverse Event (SAE)
timeFrame: Up to approximately 41 months
measure: Number of Participants Who Experienced an Immune-related Adverse Event (irAE) of Clinical Interest
timeFrame: Up to approximately 41 months
measure: Number of Participants Who Experienced an Hepatic Event of Clinical Interest (HECI)
timeFrame: Up to approximately 41 months
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to approximately 41 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center - North Campus ( Site 0621)
state: Arizona
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center ( Site 0587)
state: California
city: La Jolla
country: United States
facility: Scripps Health ( Site 0644)
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates ( Site 0588)
state: California
city: Santa Monica
country: United States
facility: UCLA ( Site 0589)
state: California
city: Washington
country: United States
facility: Georgetown University ( Site 0594)
state: District of Columbia
city: Miami
country: United States
facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 0596)
state: Florida
city: Orlando
country: United States
facility: Advent Health ( Site 0595)
state: Florida
city: Tampa
country: United States
facility: Tampa General Medical Group ( Site 0629)
state: Florida
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute ( Site 0639)
state: Georgia
city: Westwood
country: United States
facility: University of Kansas Cancer Center ( Site 0600)
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 0603)
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center ( Site 0716)
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 0611)
state: New York
city: Rochester
country: United States
facility: University of Rochester ( Site 0613)
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center - Cancer Center ( Site 0612)
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center ( Site 0625)
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University ( Site 0645)
state: Oregon
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center, Inc. ( Site 0626)
state: Pennsylvania
city: Temple
country: United States
facility: Central Texas Veterans Healthcare System ( Site 0617)
state: Texas
city: Spokane
country: United States
facility: Cancer Care Northwest ( Site 0636)
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital ( Site 0001)
state: New South Wales
city: Wooloongabba
country: Australia
facility: Princess Alexandra Hospital ( Site 0007)
state: Queensland
city: Clayton
country: Australia
facility: Monash Health-Monash Medical Centre ( Site 0004)
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne ( Site 0003)
state: Victoria
city: Liverpool
country: Australia
facility: Liverpool Hospital. ( Site 0002)
city: Vancouver
country: Canada
facility: BC Cancer-Vancouver Center ( Site 0056)
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre ( Site 0053)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0055)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0050)
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0052)
state: Quebec
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule ( Site 0065)
state: Region Del Maule
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez ( Site 0064)
state: Region Metropolitana De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0070)
state: Region Metropolitana De Santiago
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur ( Site 0067)
city: Hefei
country: China
facility: First Affiliated Hospital of Anhui Medical University ( Site 0095)
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0100)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 0088)
state: Beijing
city: Fuzhou
country: China
facility: 900 Hospital of the Joint ( Site 0091)
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital ( Site 0092)
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital ( Site 0102)
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 0089)
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan Union hospital Cancer Center ( Site 0105)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0094)
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University ( Site 0093)
state: Hunan
city: Nanjing
country: China
facility: The 81st Hospital of PLA ( Site 0085)
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 0086)
state: Shanghai
city: XI An
country: China
facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0090)
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University ( Site 0087)
state: Sichuan
city: Urumqi
country: China
facility: Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0109)
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University ( Site 0097)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital ( Site 0110)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0101)
state: Zhejiang
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University ( Site 0096)
city: Medellin
country: Colombia
facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0141)
state: Antioquia
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe ( Site 0144)
state: Antioquia
city: Medellin
country: Colombia
facility: Hospital General de Medellin Luz Castro de Gutierrez ( Site 0137)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Biomelab S A S ( Site 0145)
state: Atlantico
city: Bogota
country: Colombia
facility: Administradora Country SA - Clinica del Country ( Site 0146)
state: Distrito Capital De Bogota
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia E.S.E ( Site 0142)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Fundacion Valle del Lili ( Site 0140)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A ( Site 0139)
state: Valle Del Cauca
city: Avignon
country: France
facility: Institut Sainte Catherine ( Site 0167)
city: Clichy
country: France
facility: Hopital Beaujon ( Site 0160)
city: Creteil
country: France
facility: CHU Henri Mondor ( Site 0162)
city: Lille
country: France
facility: CHRU de Lille - Hopital Claude Huriez ( Site 0159)
city: Lyon
country: France
facility: Hopital de la Croix Rousse ( Site 0157)
city: Marseille
country: France
facility: Hopital Saint Joseph ( Site 0166)
city: Orleans
country: France
facility: Centre Hospitalier Regional du Orleans ( Site 0169)
city: Rennes
country: France
facility: Centre Eugene Marquis ( Site 0158)
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy Hopital Brabois Adultes ( Site 0164)
city: Aachen
country: Germany
facility: Klinikum der Universitaet Aachen - RWTH ( Site 0185)
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0178)
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 0188)
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt ( Site 0180)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0184)
city: Koeln
country: Germany
facility: Universitaetsklinik Koeln ( Site 0189)
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig ( Site 0187)
city: Magdeburg
country: Germany
facility: Otto-Von-Guericke-Universitaet Magdeburg ( Site 0182)
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen ( Site 0179)
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg ( Site 0186)
city: Dublin
country: Ireland
facility: St Vincents University Hospital ( Site 0242)
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital ( Site 0241)
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore - Don Calabria ( Site 0289)
state: VR
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 0292)
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi ( Site 0286)
city: Padova
country: Italy
facility: Istituto Oncologico Veneto ( Site 0287)
city: Palermo
country: Italy
facility: Az Osp Univ Policlin Paolo Giaccone ( Site 0284)
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri IRCCS. ( Site 0290)
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Univers. Pisana Ospedale S. Chiara ( Site 0291)
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico ( Site 0288)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0316)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0306)
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 0322)
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0304)
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 0315)
state: Ishikawa
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 0324)
state: Kagawa
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital ( Site 0325)
state: Kagawa
city: Kawasaki
country: Japan
facility: Toranomon Hospital Kajigaya ( Site 0312)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center ( Site 0313)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0314)
state: Kanagawa
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 0319)
state: Osaka
city: Mitaka
country: Japan
facility: Kyorin University Hospital ( Site 0309)
state: Tokyo
city: Musashino
country: Japan
facility: Musashino Red Cross Hospital ( Site 0310)
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 0305)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 0321)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 0320)
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital ( Site 0317)
city: Saga
country: Japan
facility: Saga-Ken Medical Centre Koseikan ( Site 0323)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 0307)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 0311)
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital ( Site 0308)
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital ( Site 0318)
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 0464)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0462)
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital ( Site 0463)
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0460)
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0461)
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0363)
state: Cdmx
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0365)
state: Jalisco
city: Aguascalientes
country: Mexico
facility: Centro de Investigacion Medica Aguascalientes ( Site 0355)
city: Merida
country: Mexico
facility: Medical Care and Research S.A. de C.V. ( Site 0359)
city: Mexico City
country: Mexico
facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 0362)
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C. ( Site 0366)
city: Puebla
country: Mexico
facility: Unidad Medica Oncologica ( Site 0369)
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 0376)
city: Christchurch
country: New Zealand
facility: Christchurch Hospital ( Site 0377)
city: Bytom
country: Poland
facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 0419)
state: Slaskie
city: Koszalin
country: Poland
facility: Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0421)
state: Zachodniopomorskie
city: Myslowice
country: Poland
facility: ID Clinic ( Site 0431)
city: Pila
country: Poland
facility: Ars Medical Sp. z o.o. ( Site 0433)
city: Warsaw
country: Poland
facility: MTZ Clinical Research Sp. z o. o. ( Site 0427)
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0418)
city: Moscow
country: Russian Federation
facility: N.N. Blokhin NMRCO ( Site 0439)
state: Moskva
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0453)
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: Railway Hospital of OJSC ( Site 0447)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: City Clinical Oncology Center ( Site 0446)
state: Sankt-Peterburg
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0450)
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Oncology Dispensary ( Site 0441)
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 0508)
state: Barcelona [Barcelona]
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro ( Site 0513)
state: Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 0504)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 0514)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 0510)
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago ( Site 0506)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio ( Site 0509)
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe de Valencia ( Site 0505)
city: Kaoshiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0529)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0527)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 0526)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0528)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0523)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 0524)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou ( Site 0525)
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital. Mahidol Univerisity ( Site 0213)
state: Bangkok
city: HatYai
country: Thailand
facility: Songklanagarind Hospital ( Site 0214)
state: Songkhla
city: Chiang Mai
country: Thailand
facility: Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 0211)
city: Adana
country: Turkey
facility: Adana Sehir Hastanesi ( Site 0549)
city: Ankara
country: Turkey
facility: Hacettepe Uni. Tip Fakultesi ( Site 0553)
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0551)
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tip Fakultesi ( Site 0548)
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi ( Site 0544)
city: Erzurum
country: Turkey
facility: Erzurum Ataturk University Faculty of Medicine ( Site 0546)
city: İstanbul
country: Turkey
facility: Bezmi Alem Universitesi Tıp Fakultesi ( Site 0547)
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0550)
city: Malatya
country: Turkey
facility: Inonu Universitesi Medical Fakultesi ( Site 0545)
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust ( Site 0567)
state: London, City Of
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust ( Site 0565)
state: London, City Of
city: Birkenhead
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0573)
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre ( Site 0566)
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 0575)
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust ( Site 0569)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.