Clinical trial NCT04246177: Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)
Official title: A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
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)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2020-01-29
Enrollment: 450
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 efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).


Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of HCC confirmed by radiology, histology, or cytology
* Has HCC localized to the liver and not amenable to curative treatment
* Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study intervention
* Participants with Hepatitis B virus (HBV) are eligible
* Has adequately controlled blood pressure with or without antihypertensive medications
* Has adequate organ function

Exclusion Criteria:

* Is currently a candidate for liver transplantation
* Has had gastric bleeding within the last 6 months
* Has ascites that is not controlled with medication
* Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure
* Has a serious nonhealing wound, ulcer, or bone fracture
* Has received locoregional therapy to existing liver lesions

Primary outcomes:
measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to ~43 months
measure: Overall Survival (OS)
timeFrame: Up to ~95 months
Secondary outcomes:
measure: PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Up to ~43 months
measure: Objective Response Rate (ORR) per mRECIST
timeFrame: Up to ~95 months
measure: Disease Control Rate (DCR) per mRECIST
timeFrame: Up to ~95 months
measure: Duration of Response (DOR) per mRECIST
timeFrame: Up to ~95 months
measure: Time to Progression (TTP) per mRECIST
timeFrame: Up to ~95 months
measure: Percentage of Participants Who Experience At Least One Adverse Event (AE)
timeFrame: Up to ~95 months
measure: Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE)
timeFrame: Up to ~95 months
measure: Percentage of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI)
timeFrame: Up to ~95 months
measure: Percentage of Participants Who Discontinue Study Drug Due to an AE
timeFrame: Up to ~95 months
measure: ORR per RESCIST 1.1
timeFrame: Up to ~95 months
measure: DCR per RECIST 1.1
timeFrame: Up to ~95 months
measure: DOR per RECIST 1.1
timeFrame: Up to ~95 months
measure: TTP per RECIST 1.1
timeFrame: Up to ~95 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates PC- HOPE ( Site 0770)
state: Arizona
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines ( Site 0714)
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center ( Site 0717)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica ( Site 0720)
state: California
city: Orange
country: United States
facility: UC Irvine Health ( Site 0718)
state: California
city: New Haven
country: United States
facility: Yale Cancer Center ( Site 0724)
state: Connecticut
city: Tampa
country: United States
facility: Tampa General Hospital ( Site 0764)
state: Florida
city: Boise
country: United States
facility: Mountain States Tumor Institute ( Site 0773)
state: Idaho
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics ( Site 0729)
state: Iowa
city: Westwood
country: United States
facility: University of Kansas Cancer Center ( Site 0731)
state: Kansas
city: Louisville
country: United States
facility: University of Louisville ( Site 0757)
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Medical Center ( Site 0787)
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans ( Site 0733)
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital-GI/Hepatology Research ( Site 0735)
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University ( Site 0769)
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center ( Site 0805)
state: New Mexico
city: Lake Success
country: United States
facility: Monter Cancer Center ( Site 0780)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 0744)
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health ( Site 0741)
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center ( Site 0791)
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center ( Site 0759)
state: Ohio
city: Sylvania
country: United States
facility: ProMedica Flower Hospital ( Site 0796)
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center ( Site 0745)
state: Oklahoma
city: Portland
country: United States
facility: OHSU Center for Health & Healing ( Site 0746)
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Medical Center ( Site 0766)
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Research Institute ( Site 0784)
state: Texas
city: Huntington
country: United States
facility: Edwards Comprehensive Cancer Center ( Site 0786)
state: West Virginia
city: Kogarah
country: Australia
facility: St George Hospital ( Site 0005)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital ( Site 0006)
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Health ( Site 0008)
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health ( Site 0004)
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital ( Site 0002)
state: Western Australia
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057)
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056)
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Clinica de Oncologia Reichow ( Site 0052)
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)
state: Sao Paulo
city: JAU
country: Brazil
facility: Fundacao Dr Amaral Carvalho ( Site 0050)
state: Sao Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0043)
state: Sao Paulo
city: São Paulo
country: Brazil
facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: A.C. Camargo Cancer Center ( Site 0054)
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 0064)
state: Araucania
city: Santiago
country: Chile
facility: Centro de Oncología de Precisión-Oncology ( Site 0068)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 0066)
state: Region M. De Santiago
city: Heifei
country: China
facility: Anhui Provincial Hospital ( Site 0092)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 0099)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 0105)
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 0087)
state: Beijing
city: Chongqing
country: China
facility: Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)
state: Chongqing
city: Wanzhou
country: China
facility: Chongqing Three Gorges Central Hospital ( Site 0859)
state: Chongqing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 0085)
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University ( Site 0089)
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)
state: Fujian
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University ( Site 0115)
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People s Hospital ( Site 0100)
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University ( Site 0088)
state: Guangdong
city: Guangzhou
country: China
facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE-Department of Medical Imaging and Interventional Radiology ( Si
state: Guangdong
city: Zhuhai
country: China
facility: Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital ( Site 0112)
state: Hainan
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 0090)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 0114)
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 0101)
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital ( Site 0113)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0096)
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University ( Site 0120)
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)
state: Jiangxi
city: Xi'an
country: China
facility: Xi'an International Medical Center Hospital ( Site 0860)
state: Shaanxi
city: Shanghai
country: China
facility: The Third Affiliated Hospital of Naval Medical University ( Site 0123)
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 0106)
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University ( Site 0084)
state: Shanghai
city: XI An
country: China
facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University ( Site 0119)
state: Sichuan
city: Suining
country: China
facility: Suining Central Hospital ( Site 0857)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0098)
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Third Central Hospital ( Site 0861)
state: Tianjin
city: Kunming
country: China
facility: The First Hospital of Kunming ( Site 0124)
state: Yunnan
city: Hangzhou
country: China
facility: 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital ( Site 0094)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0103)
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center ( Site 0132)
state: Zhejiang
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe ( Site 0145)
state: Antioquia
city: Bogota
country: Colombia
facility: Administradora Country S.A. ( Site 0137)
state: Distrito Capital De Bogota
city: Piedecuesta
country: Colombia
facility: Fundacion Cardiovascular de Colombia ( Site 0136)
state: Santander
city: Cali
country: Colombia
facility: Fundacion Valle del Lili ( Site 0140)
state: Valle Del Cauca
city: Herlev
country: Denmark
facility: Herlev Hospital ( Site 0170)
state: Hovedstaden
city: Aarhus N
country: Denmark
facility: Aarhus Universitets hospital ( Site 0175)
state: Midtjylland
city: Odense
country: Denmark
facility: Odense Universitetshospital ( Site 0160)
state: Syddanmark
city: Lyon
country: France
facility: Hopital de la Croix-Rousse ( Site 0193)
state: Auvergne
city: Marseille
country: France
facility: Hopital de la Timone ( Site 0188)
state: Bouches-du-Rhone
city: Pessac Cedex
country: France
facility: CHU Bordeaux Haut-Leveque ( Site 0185)
state: Gironde
city: Vandoeuvre les Nancy
country: France
facility: C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)
state: Meurthe-et-Moselle
city: Creteil
country: France
facility: A.P.H. Paris, Hopital Henri Mondor ( Site 0179)
state: Val-de-Marne
city: Villejuif
country: France
facility: Hopital Paul Brousse ( Site 0182)
state: Val-de-Marne
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg ( Site 0199)
state: Baden-Wurttemberg
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nord-West GmbH ( Site 0208)
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 0200)
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn ( Site 0203)
state: Nordrhein-Westfalen
city: Halle (Saale)
country: Germany
facility: Universitaetsklinikum Halle ( Site 0213)
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig ( Site 0202)
state: Sachsen
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin ( Site 0204)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital ( Site 0242)
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)
state: Somogy
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz ( Site 0265)
state: Zala
city: Budapest
country: Hungary
facility: Semmelweis University ( Site 0264)
city: Dublin
country: Ireland
facility: St Vincents University Hospital ( Site 0690)
city: Afula
country: Israel
facility: Emek Medical Center ( Site 0307)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 0305)
city: Jerusaelm
country: Israel
facility: Hadassah Ein Karem Jerusalem ( Site 0303)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0304)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0306)
city: Napoli
country: Italy
facility: Ospedale del Mare ( Site 0327)
state: Campania
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)
state: Milano
city: Torino
country: Italy
facility: Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)
state: Piemonte
city: Messina
country: Italy
facility: AOU Policlinico G. Martino ( Site 0324)
state: Sicilia
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)
city: Napoli
country: Italy
facility: Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)
city: Ravenna
country: Italy
facility: Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)
city: Roma
country: Italy
facility: Policlinico Universitario -Agostino Gemelli ( Site 0328)
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0347)
state: Chiba
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 0368)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 0362)
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0345)
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 0354)
state: Ishikawa
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital ( Site 0364)
state: Kagawa
city: Kawasaki
country: Japan
facility: Toranomon Hospital Kajigaya ( Site 0369)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center ( Site 0351)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0352)
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 0359)
state: Nara
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 0358)
state: Osaka
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital ( Site 0370)
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0365)
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital ( Site 0353)
state: Tochigi
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 0346)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 0361)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 0360)
city: Kumamoto
country: Japan
facility: Kumamoto University ( Site 0372)
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine ( Site 0367)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0357)
city: Osaka
country: Japan
facility: Japanese Red Cross Osaka Hospital ( Site 0356)
city: Saga
country: Japan
facility: Saga-Ken Medical Centre Koseikan ( Site 0363)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 0349)
city: Tokyo
country: Japan
facility: Juntendo University Hospital ( Site 0371)
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital ( Site 0348)
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital ( Site 0572)
state: Jeonranamdo
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 0570)
state: Kyonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital ( Site 0568)
state: Pusan-Kwangyokshi
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital ( Site 0569)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0567)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0564)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0565)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0566)
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Mary s Hospital ( Site 0571)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 0573)
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre ( Site 0440)
state: Limburg
city: Amsterdam
country: Netherlands
facility: AMC ( Site 0438)
state: Noord-Holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center ( Site 0439)
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 0459)
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Ullevål ( Site 0500)
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra ( Site 0502)
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central, EPE - Hosp St. Ant dos Capuchos ( Site 0505)
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)
city: Porto
country: Portugal
facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research LLC ( Site 0527)
city: San Juan
country: Puerto Rico
facility: Puerto Rico Medical Research Center LLC ( Site 0523)
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System ( Site 0524)
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research ( Site 0522)
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro ( Site 0596)
state: Madrid
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia ( Site 0595)
state: Valenciana, Comunitat
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 0598)
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal ( Site 0593)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos ( Site 0597)
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio ( Site 0591)
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)
state: Kaohsiung
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital ( Site 0611)
city: Taichung
country: Taiwan
facility: China Medical University Hospital-Surgical Department ( Site 0610)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 0613)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0608)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0606)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou ( Site 0607)
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 0627)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital, Mahidol University ( Site 0628)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 0629)
state: Krung Thep Maha Nakhon
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty ( Site 0653)
city: Ankara
country: Turkey
facility: Ankara City Hospital-Medical Oncology ( Site 0661)
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)
city: Istanbul
country: Turkey
facility: Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)
city: Izmir
country: Turkey
facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)
city: Izmir
country: Turkey
facility: I.E.U. Medical Point Hastanesi ( Site 0649)
city: Konya
country: Turkey
facility: Konya Necmettin Erbakan University Medical Faculty ( Site 0652)
city: Malatya
country: Turkey
facility: Inonu Universitesi Medical Fakultesi ( Site 0650)
city: Kharkiv
country: Ukraine
facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0673)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: Shalimov s NI of Surgery and Transplantation ( Site 0671)
state: Kyivska Oblast
city: London
country: United Kingdom
facility: Barts Health NHS Trust ( Site 0692)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust ( Site 0694)
state: London, City Of
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Trust ( Site 0693)
state: London, City Of
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Verset G, Borbath I, Karwal M, Verslype C, Van Vlierberghe H, Kardosh A, Zagonel V, Stal P, Sarker D, Palmer DH, Vogel A, Edeline J, Cattan S, Kudo M, Cheng AL, Ogasawara S, Daniele B, Chan SL, Knox JJ, Qin S, Siegel AB, Chisamore M, Hatogai K, Wang A, Finn RS, Zhu AX. Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial. Clin Cancer Res. 2022 Jun 13;28(12):2547-2554. doi: 10.1158/1078-0432.CCR-21-3807.
citation: Llovet JM, Vogel A, Madoff DC, Finn RS, Ogasawara S, Ren Z, Mody K, Li JJ, Siegel AB, Dubrovsky L, Kudo M. Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment. Cardiovasc Intervent Radiol. 2022 Apr;45(4):405-412. doi: 10.1007/s00270-021-03031-9. Epub 2022 Feb 4.
citation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.
citation: Kloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. No abstract available.