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)
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)
8 other identifiers
interventional
479
27 countries
205
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2020
Longer than P75 for phase_3
205 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2020
CompletedFirst Posted
Study publicly available on registry
January 29, 2020
CompletedStudy Start
First participant enrolled
May 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2026
CompletedApril 22, 2026
April 1, 2026
5.2 years
January 27, 2020
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR).
Up to ~43 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Up to ~95 months
Secondary Outcomes (13)
PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Up to ~43 months
Objective Response Rate (ORR) per mRECIST
Up to ~95 months
Disease Control Rate (DCR) per mRECIST
Up to ~95 months
Duration of Response (DOR) per mRECIST
Up to ~95 months
Time to Progression (TTP) per mRECIST
Up to ~95 months
- +8 more secondary outcomes
Study Arms (2)
Lenvatinib plus Pembrolizumab plus TACE
EXPERIMENTALParticipants will receive a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib will be administered at a dose of 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 during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).
Oral Placebo plus IV Placebo plus TACE
ACTIVE COMPARATORParticipants will receive a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo will be administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).
Interventions
Administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) via oral capsules once a day during each 21-day cycle.
Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).
Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.
Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).
Conducted as a background procedure of chemotherapeutic and embolic agent(s).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- Eisai Inc.collaborator
Study Sites (205)
Arizona Oncology Associates PC- HOPE ( Site 0770)
Tucson, Arizona, 85711, United States
Scripps Clinic Torrey Pines ( Site 0714)
La Jolla, California, 92037, United States
USC Norris Comprehensive Cancer Center ( Site 0717)
Los Angeles, California, 90033, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0720)
Los Angeles, California, 90404, United States
UC Irvine Health ( Site 0718)
Orange, California, 92868, United States
Yale Cancer Center ( Site 0724)
New Haven, Connecticut, 06510, United States
Tampa General Hospital ( Site 0764)
Tampa, Florida, 33606, United States
Mountain States Tumor Institute ( Site 0773)
Boise, Idaho, 83712, United States
University of Iowa Hospital and Clinics ( Site 0729)
Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center ( Site 0731)
Westwood, Kansas, 66205, United States
University of Louisville ( Site 0757)
Louisville, Kentucky, 40202, United States
Tulane Medical Center ( Site 0787)
New Orleans, Louisiana, 70112, United States
University Medical Center New Orleans ( Site 0733)
New Orleans, Louisiana, 70112, United States
Henry Ford Hospital-GI/Hepatology Research ( Site 0735)
Detroit, Michigan, 48202, United States
Saint Louis University ( Site 0769)
St Louis, Missouri, 63110, United States
University of New Mexico Comprehensive Cancer Center ( Site 0805)
Albuquerque, New Mexico, 87106, United States
Monter Cancer Center ( Site 0780)
Lake Success, New York, 11042, United States
Icahn School of Medicine at Mount Sinai ( Site 0744)
New York, New York, 10029, United States
Wake Forest Baptist Health ( Site 0741)
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Medical Center ( Site 0791)
Cincinnati, Ohio, 45219, United States
The Ohio State University Wexner Medical Center ( Site 0759)
Columbus, Ohio, 43210, United States
ProMedica Flower Hospital ( Site 0796)
Sylvania, Ohio, 43560, United States
Stephenson Cancer Center ( Site 0745)
Oklahoma City, Oklahoma, 73104, United States
OHSU Center for Health & Healing ( Site 0746)
Portland, Oregon, 97239, United States
Penn State Hershey Medical Center ( Site 0766)
Hershey, Pennsylvania, 17033-0850, United States
Houston Methodist Research Institute ( Site 0784)
Houston, Texas, 77030, United States
Edwards Comprehensive Cancer Center ( Site 0786)
Huntington, West Virginia, 25701, United States
St George Hospital ( Site 0005)
Kogarah, New South Wales, 2217, Australia
Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)
Westmead, New South Wales, 2145, Australia
Princess Alexandra Hospital ( Site 0006)
Brisbane, Queensland, 4102, Australia
Austin Health ( Site 0008)
Heidelberg, Victoria, 3084, Australia
Alfred Health ( Site 0004)
Melbourne, Victoria, 3004, Australia
Royal Perth Hospital ( Site 0002)
Perth, Western Australia, 6000, Australia
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057)
Natal, Rio Grande do Norte, 59075-740, Brazil
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056)
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Clinica de Oncologia Reichow ( Site 0052)
Blumenau, Santa Catarina, 89010-340, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)
Barretos, São Paulo, 14784-400, Brazil
Fundacao Dr Amaral Carvalho ( Site 0050)
Jaú, São Paulo, 17210-120, Brazil
Hospital de Base de Sao Jose de Rio Preto ( Site 0043)
São José do Rio Preto, São Paulo, 15090-000, Brazil
BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)
São Paulo, São Paulo, 01323-001, Brazil
A.C. Camargo Cancer Center ( Site 0054)
São Paulo, 01509-900, Brazil
Centro Investigación del Cáncer James Lind ( Site 0064)
Temuco, Araucania, 4800827, Chile
Centro de Oncología de Precisión-Oncology ( Site 0068)
Santiago, Region M. de Santiago, 7560908, Chile
Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)
Santiago, Region M. de Santiago, 8330024, Chile
Bradfordhill ( Site 0066)
Santiago, Region M. de Santiago, 8420383, Chile
Anhui Provincial Hospital ( Site 0092)
Heifei, Anhui, 230001, China
Beijing Cancer Hospital ( Site 0099)
Beijing, Beijing Municipality, 100142, China
Beijing Cancer Hospital ( Site 0105)
Beijing, Beijing Municipality, 100142, China
Peking Union Medical College Hospital ( Site 0087)
Beijing, Beijing Municipality, 100730, China
Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)
Chongqing, Chongqing Municipality, 400042, China
Chongqing University Three Gorges Hospital ( Site 0859)
Chongqing, Chongqing Municipality, 404000, China
Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)
Fuzhou, Fujian, 350008, China
Fujian Provincial Cancer Hospital ( Site 0085)
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Fujian Medical University ( Site 0089)
Fuzhou, Fujian, 350014, China
Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)
Xiamen, Fujian, 361015, China
Zhujiang Hospital of Southern Medical University ( Site 0115)
Guangzhou, Guangdong, 510000, China
Guangdong Provincial People s Hospital ( Site 0100)
Guangzhou, Guangdong, 510080, China
NANFANG HOSPITAL SOUTHERN MEDICAL UNIVERSITY ( Site 0088)
Guangzhou, Guangdong, 510515, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0128)
Guangzhou, Guangdong, 510700, China
Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)
Zhuhai, Guangdong, 519000, China
Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)
Nanning, Guangxi, 530021, China
Hainan General Hospital ( Site 0112)
Haikou, Hainan, 570311, China
Harbin Medical University Cancer Hospital ( Site 0090)
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital ( Site 0114)
Zhengzhou, Henan, 450008, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)
Wuhan, Hubei, 430000, China
Hubei Cancer Hospital ( Site 0101)
Wuhan, Hubei, 430079, China
Hunan Provincial People's Hospital ( Site 0113)
Changsha, Hunan, 410005, China
Hunan Cancer Hospital ( Site 0096)
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Soochow University ( Site 0120)
Suzhou, Jiangsu, 215006, China
Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)
Nanchang, Jiangxi, 330029, China
Xi'an International Medical Center Hospital ( Site 0860)
Xi'an, Shaanxi, 710100, China
The Third Affiliated Hospital of the PLA Navy Medical University ( Site 0123)
Shanghai, Shanghai Municipality, 200028, China
Fudan University Shanghai Cancer Center ( Site 0106)
Shanghai, Shanghai Municipality, 200032, China
Zhongshan Hospital Fudan University ( Site 0084)
Shanghai, Shanghai Municipality, 200032, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)
Xi’an, Shanxi, 710048, China
West China Hospital of Sichuan University ( Site 0119)
Chengdu, Sichuan, 610041, China
Suining Central Hospital ( Site 0857)
Suining, Sichuan, 629000, China
Tianjin Medical University Cancer Institute & Hospital ( Site 0098)
Tianjin, Tianjin Municipality, 300060, China
Tianjin Third Central Hospital ( Site 0861)
Tianjin, Tianjin Municipality, 300170, China
The First Hospital of Kunming ( Site 0124)
Kunming, Yunnan, 650200, China
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital ( Site 0094)
Hangzhou, Zhejiang, 310018, China
Zhejiang Cancer Hospital ( Site 0103)
Hangzhou, Zhejiang, 310022, China
Ningbo Medical Center LiHuili Hospital ( Site 0132)
Ningbo, Zhejiang, 315048, China
Hospital Pablo Tobon Uribe ( Site 0145)
Medellín, Antioquia, 050034, Colombia
Administradora Country S.A. ( Site 0137)
Bogotá, Bogota D.C., 110221, Colombia
Fundacion Cardiovascular de Colombia ( Site 0136)
Piedecuesta, Santander Department, 681017, Colombia
Fundación Valle del Lili ( Site 0140)
Cali, Valle del Cauca Department, 760032, Colombia
Herlev Hospital ( Site 0170)
Herlev, Capital Region, 2730, Denmark
Aarhus Universitets hospital ( Site 0175)
Aarhus N, Central Jutland, 8200, Denmark
Odense Universitetshospital ( Site 0160)
Odense, Region Syddanmark, 5000, Denmark
Hopital de la Croix-Rousse ( Site 0193)
Lyon, Auvergne, 69004, France
Hopital de la Timone ( Site 0188)
Marseille, Bouches-du-Rhone, 13005, France
CHU Bordeaux Haut-Leveque ( Site 0185)
Pessac, Gironde, 33604, France
C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France
A.P.H. Paris, Hopital Henri Mondor ( Site 0179)
Créteil, Val-de-Marne, 94000, France
Hopital Paul Brousse ( Site 0182)
Villejuif, Val-de-Marne, 94800, France
Universitaetsklinikum Freiburg ( Site 0199)
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Krankenhaus Nord-West GmbH ( Site 0208)
Frankfurt am Main, Hesse, 60488, Germany
Medizinische Hochschule Hannover ( Site 0200)
Hanover, Lower Saxony, 30625, Germany
Universitaetsklinikum Bonn ( Site 0203)
Bonn, North Rhine-Westphalia, 53127, Germany
Universitaetsklinikum Leipzig ( Site 0202)
Leipzig, Saxony, 04103, Germany
Universitaetsklinikum Halle ( Site 0213)
Halle, Saxony-Anhalt, 06120, Germany
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)
Lübeck, Schleswig-Holstein, 23538, Germany
Charite - Universitaetsmedizin ( Site 0204)
Berlin, 13353, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)
Hamburg, 20246, Germany
Prince of Wales Hospital ( Site 0242)
Shatin, Hong Kong
Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)
Kaposvár, Somogy County, 7400, Hungary
Zala Megyei Szent Rafael Korhaz ( Site 0265)
Zalaegerszeg, Zala County, 8900, Hungary
Semmelweis University ( Site 0264)
Budapest, 1085, Hungary
St Vincents University Hospital ( Site 0690)
Dublin, D04 T6F4, Ireland
Emek Medical Center ( Site 0307)
Afula, 1834111, Israel
Rambam Health Care Campus-Oncology Division ( Site 0305)
Haifa, 3109601, Israel
Hadassah Ein Karem Jerusalem ( Site 0303)
Jerusaelm, 9112001, Israel
Rabin Medical Center ( Site 0304)
Petah Tikva, 4941 492, Israel
Sourasky Medical Center ( Site 0306)
Tel Aviv, 6423906, Israel
Ospedale del Mare ( Site 0327)
Naples, Campania, 80147, Italy
ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)
Milan, Milano, 20162, Italy
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)
Turin, Piedmont, 10128, Italy
AOU Policlinico G. Martino ( Site 0324)
Messina, Sicily, 98124, Italy
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)
Brescia, 25123, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)
Milan, 20122, Italy
Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)
Naples, 80131, Italy
Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)
Ravenna, 48121, Italy
Policlinico Universitario -Agostino Gemelli ( Site 0328)
Roma, 00168, Italy
National Cancer Center Hospital East ( Site 0347)
Kashiwa, Chiba, 277-8577, Japan
Ehime University Hospital ( Site 0368)
Tōon, Ehime, 791-0295, Japan
Kurume University Hospital ( Site 0362)
Kurume, Fukuoka, 830-0011, Japan
Sapporo Kosei General Hospital ( Site 0345)
Sapporo, Hokkaido, 060-0033, Japan
Kanazawa University Hospital ( Site 0354)
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kagawa Prefectural Central Hospital ( Site 0364)
Takamatsu, Kagawa-ken, 760-8557, Japan
Toranomon Hospital Kajigaya ( Site 0369)
Kawasaki, Kanagawa, 213-8587, Japan
Yokohama City University Medical Center ( Site 0351)
Yokohama, Kanagawa, 232-0024, Japan
Kanagawa Cancer Center ( Site 0352)
Yokohama, Kanagawa, 241-8515, Japan
Nara Medical University Hospital ( Site 0359)
Kashihara, Nara, 634-8522, Japan
Kindai University Hospital ( Site 0358)
Sayama, Osaka, 589-8511, Japan
Saitama Medical University Hospital ( Site 0370)
Iruma-gun, Saitama, 350-0495, Japan
Shizuoka Cancer Center ( Site 0365)
Suntogun, Shizuoka, 411-8777, Japan
Jichi Medical University Hospital ( Site 0353)
Shimotsuke, Tochigi, 329-0498, Japan
Chiba University Hospital ( Site 0346)
Chiba, 260-8677, Japan
National Hospital Organization Kyushu Medical Center ( Site 0361)
Fukuoka, 8108563, Japan
Hiroshima University Hospital ( Site 0360)
Hiroshima, 734-8551, Japan
Kumamoto University Hospital ( Site 0372)
Kumamoto, 860-8556, Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 0367)
Kyoto, 602-8566, Japan
Osaka International Cancer Institute ( Site 0357)
Osaka, 541-8567, Japan
Japanese Red Cross Osaka Hospital ( Site 0356)
Osaka, 543-8555, Japan
Saga-Ken Medical Centre Koseikan ( Site 0363)
Saga, 840-8571, Japan
Toranomon Hospital ( Site 0349)
Tokyo, 105-8470, Japan
Juntendo University Hospital ( Site 0371)
Tokyo, 113-0033, Japan
The University of Tokyo Hospital ( Site 0348)
Tokyo, 113-8655, Japan
Maastricht University Medical Centre ( Site 0440)
Maastricht, Limburg, 6229 HX, Netherlands
AMC ( Site 0438)
Amsterdam, North Holland, 1105 AZ, Netherlands
Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)
Leiden, South Holland, 2333 ZA, Netherlands
Erasmus University Medical Center ( Site 0439)
Rotterdam, South Holland, 3015 GD, Netherlands
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)
Utrecht, 3584 CX, Netherlands
Auckland City Hospital ( Site 0459)
Auckland, 1023, New Zealand
Oslo Universitetssykehus Ullevål ( Site 0500)
Oslo, 0450, Norway
Centro Hospitalar e Universitario de Coimbra ( Site 0502)
Coimbra, 3000-075, Portugal
Unidade Local de Saude de São José - Hospital de Santo Antonio dos Capuchos ( Site 0505)
Lisbon, 1169-050, Portugal
Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)
Porto, 4099-001, Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)
Porto, 4200-072, Portugal
Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)
Porto, 4200-319, Portugal
Puerto Rico Medical Research Center LLC ( Site 0523)
Hato Rey, 00917, Puerto Rico
Ad-Vance Medical Research LLC ( Site 0527)
Ponce, 00717, Puerto Rico
VA Caribbean Healthcare System ( Site 0524)
San Juan, 00921-3201, Puerto Rico
FDI Clinical Research ( Site 0522)
San Juan, 00927, Puerto Rico
Chonnam National University Hwasun Hospital ( Site 0572)
Hwasun, Jeonranamdo, 58128, South Korea
Seoul National University Bundang Hospital ( Site 0570)
Seongnam-si, Kyonggi-do, 13620, South Korea
Pusan National University Hospital ( Site 0568)
Busan, Pusan-Kwangyokshi, 49241, South Korea
Kyungpook National University Hospital ( Site 0569)
Daegu, Taegu-Kwangyokshi, 41944, South Korea
Seoul National University Hospital ( Site 0567)
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System ( Site 0564)
Seoul, 03722, South Korea
Asan Medical Center ( Site 0565)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 0566)
Seoul, 06351, South Korea
The Catholic University of Korea St. Mary s Hospital ( Site 0571)
Seoul, 06591, South Korea
Korea University Guro Hospital ( Site 0573)
Seoul, 08308, South Korea
Hospital Universitario Puerta de Hierro ( Site 0596)
Majadahonda, Madrid, 28222, Spain
Hospital General Universitario de Valencia ( Site 0595)
Valencia, Valenciana, Comunitat, 46014, Spain
Hospital General Universitario Gregorio Maranon ( Site 0598)
Madrid, 28007, Spain
Hospital Ramon y Cajal ( Site 0593)
Madrid, 28034, Spain
Hospital Clinico San Carlos ( Site 0597)
Madrid, 28040, Spain
Hospital Virgen del Rocio ( Site 0591)
Seville, 41013, Spain
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)
Kaohsiung City, Kaohsiung, 833, Taiwan
Kaohsiung Medical University Hospital ( Site 0611)
Kaohsiung City, 807, Taiwan
China Medical University Hospital-Surgical Department ( Site 0610)
Taichung, 40447, Taiwan
Taichung Veterans General Hospital ( Site 0613)
Taichung, 407, Taiwan
National Cheng Kung University Hospital ( Site 0608)
Tainan, 70457, Taiwan
National Taiwan University Hospital ( Site 0606)
Taipei, 10002, Taiwan
Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine ( Site 0612)
Taipei, 112201, Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0607)
Taoyuan District, 333, Taiwan
Chulalongkorn University ( Site 0627)
Bangkok, Bangkok, 10330, Thailand
Ramathibodi Hospital, Mahidol University ( Site 0628)
Bangkok, Bangkok, 10400, Thailand
Faculty of Medicine Siriraj Hospital ( Site 0629)
Bangkok, Bangkok, 10700, Thailand
Hacettepe University Medical Faculty ( Site 0653)
Ankara, 06230, Turkey (Türkiye)
Ankara City Hospital-Medical Oncology ( Site 0661)
Ankara, 06800, Turkey (Türkiye)
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)
Edirne, 22030, Turkey (Türkiye)
Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)
Istanbul, 34093, Turkey (Türkiye)
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)
Izmir, 35100, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi ( Site 0649)
Izmir, 35575, Turkey (Türkiye)
Konya Necmettin Erbakan University Medical Faculty ( Site 0652)
Konya, 42080, Turkey (Türkiye)
Inonu Universitesi Medical Fakultesi ( Site 0650)
Malatya, 44280, Turkey (Türkiye)
Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)
Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine
Barts Health NHS Trust ( Site 0692)
London, London, City of, EC1A 7BE, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 0694)
London, London, City of, SW3 6JJ, United Kingdom
Royal Marsden NHS Trust ( Site 0693)
Sutton, London, City of, SM2 5PT, United Kingdom
Related Publications (5)
Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim JH, Zhao H, Li C, Madoff DC, Ghobrial RM, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry AB, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel AB, Finn RS, Llovet JM; LEAP-012 investigators. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2025 Jan 18;405(10474):203-215. doi: 10.1016/S0140-6736(24)02575-3. Epub 2025 Jan 8.
PMID: 39798578RESULTVerset 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.
PMID: 35421228DERIVEDLlovet 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.
PMID: 35119481DERIVEDTaylor 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.
PMID: 33300372DERIVEDKloeckner 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.
PMID: 32557715DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2020
First Posted
January 29, 2020
Study Start
May 22, 2020
Primary Completion
August 19, 2025
Study Completion
March 23, 2026
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf