AzTrials
AzTrials

Carcinoma, HepatocellularPhase 3NCT04246177

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 study testing Lenvatinib, Pembrolizumab and TACE in people with Carcinoma, Hepatocellular, run by Merck Sharp & Dohme LLC at 205 sites in 27 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Lenvatinib, Pembrolizumab and TACE
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
480 participants
Where
205 sitesin 27 countries
Study dates
22 May 2020to 26 Mar 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

205 sites in 27 countries.

205 sites in 27 countries

China39 sites

  • Beijing Cancer Hospital ( Site 0099)

    Beijing, Beijing Municipality, 100142

  • Beijing Cancer Hospital ( Site 0105)

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital ( Site 0087)

    Beijing, Beijing Municipality, 100730

  • Hunan Provincial People's Hospital ( Site 0113)

    Changsha, Hunan, 410005

  • Hunan Cancer Hospital ( Site 0096)

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University ( Site 0119)

    Chengdu, Sichuan, 610041

  • Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)

    Chongqing, Chongqing Municipality, 400042

  • Chongqing University Three Gorges Hospital ( Site 0859)

    Chongqing, Chongqing Municipality, 404000

  • Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)

    Fuzhou, Fujian, 350008

  • Fujian Provincial Cancer Hospital ( Site 0085)

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospital of Fujian Medical University ( Site 0089)

    Fuzhou, Fujian, 350014

  • Zhujiang Hospital of Southern Medical University ( Site 0115)

    Guangzhou, Guangdong, 510000

  • Guangdong Provincial People s Hospital ( Site 0100)

    Guangzhou, Guangdong, 510080

  • NANFANG HOSPITAL SOUTHERN MEDICAL UNIVERSITY ( Site 0088)

    Guangzhou, Guangdong, 510515

  • SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0128)

    Guangzhou, Guangdong, 510700

  • Hainan General Hospital ( Site 0112)

    Haikou, Hainan, 570311

  • 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital ( Site 0094)

    Hangzhou, Zhejiang, 310018

  • Zhejiang Cancer Hospital ( Site 0103)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital ( Site 0090)

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital ( Site 0092)

    Heifei, Anhui, 230001

  • The First Hospital of Kunming ( Site 0124)

    Kunming, Yunnan, 650200

  • Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)

    Nanchang, Jiangxi, 330029

  • Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)

    Nanning, Guangxi, 530021

  • Ningbo Medical Center LiHuili Hospital ( Site 0132)

    Ningbo, Zhejiang, 315048

  • The Third Affiliated Hospital of the PLA Navy Medical University ( Site 0123)

    Shanghai, Shanghai Municipality, 200028

  • Fudan University Shanghai Cancer Center ( Site 0106)

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital Fudan University ( Site 0084)

    Shanghai, Shanghai Municipality, 200032

  • Suining Central Hospital ( Site 0857)

    Suining, Sichuan, 629000

  • The First Affiliated Hospital of Soochow University ( Site 0120)

    Suzhou, Jiangsu, 215006

  • Tianjin Medical University Cancer Institute & Hospital ( Site 0098)

    Tianjin, Tianjin Municipality, 300060

  • Tianjin Third Central Hospital ( Site 0861)

    Tianjin, Tianjin Municipality, 300170

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)

    Wuhan, Hubei, 430000

  • Hubei Cancer Hospital ( Site 0101)

    Wuhan, Hubei, 430079

  • Xi'an International Medical Center Hospital ( Site 0860)

    Xi'an, Shaanxi, 710100

  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)

    Xi’an, Shanxi, 710048

  • Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)

    Xiamen, Fujian, 361015

  • Henan Cancer Hospital ( Site 0114)

    Zhengzhou, Henan, 450008

  • Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)

    Zhuhai, Guangdong, 519000

Other trials in China

United States27 sites

  • University of New Mexico Comprehensive Cancer Center ( Site 0805)

    Albuquerque, New Mexico, 87106

  • Mountain States Tumor Institute ( Site 0773)

    Boise, Idaho, 83712

  • University of Cincinnati Medical Center ( Site 0791)

    Cincinnati, Ohio, 45219

  • The Ohio State University Wexner Medical Center ( Site 0759)

    Columbus, Ohio, 43210

  • Henry Ford Hospital-GI/Hepatology Research ( Site 0735)

    Detroit, Michigan, 48202

  • Penn State Hershey Medical Center ( Site 0766)

    Hershey, Pennsylvania, 17033-0850

  • Houston Methodist Research Institute ( Site 0784)

    Houston, Texas, 77030

  • Edwards Comprehensive Cancer Center ( Site 0786)

    Huntington, West Virginia, 25701

  • University of Iowa Hospital and Clinics ( Site 0729)

    Iowa City, Iowa, 52242

  • Scripps Clinic Torrey Pines ( Site 0714)

    La Jolla, California, 92037

  • Monter Cancer Center ( Site 0780)

    Lake Success, New York, 11042

  • USC Norris Comprehensive Cancer Center ( Site 0717)

    Los Angeles, California, 90033

  • UCLA Hematology/Oncology - Santa Monica ( Site 0720)

    Los Angeles, California, 90404

  • University of Louisville ( Site 0757)

    Louisville, Kentucky, 40202

  • Yale Cancer Center ( Site 0724)

    New Haven, Connecticut, 06510

  • Tulane Medical Center ( Site 0787)

    New Orleans, Louisiana, 70112

  • University Medical Center New Orleans ( Site 0733)

    New Orleans, Louisiana, 70112

  • Icahn School of Medicine at Mount Sinai ( Site 0744)

    New York, New York, 10029

  • Stephenson Cancer Center ( Site 0745)

    Oklahoma City, Oklahoma, 73104

  • UC Irvine Health ( Site 0718)

    Orange, California, 92868

  • OHSU Center for Health & Healing ( Site 0746)

    Portland, Oregon, 97239

  • Saint Louis University ( Site 0769)

    St Louis, Missouri, 63110

  • ProMedica Flower Hospital ( Site 0796)

    Sylvania, Ohio, 43560

  • Tampa General Hospital ( Site 0764)

    Tampa, Florida, 33606

  • Arizona Oncology Associates PC- HOPE ( Site 0770)

    Tucson, Arizona, 85711

  • University of Kansas Cancer Center ( Site 0731)

    Westwood, Kansas, 66205

  • Wake Forest Baptist Health ( Site 0741)

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan25 sites

  • Chiba University Hospital ( Site 0346)

    Chiba, 260-8677

  • National Hospital Organization Kyushu Medical Center ( Site 0361)

    Fukuoka, 8108563

  • Hiroshima University Hospital ( Site 0360)

    Hiroshima, 734-8551

  • Saitama Medical University Hospital ( Site 0370)

    Iruma-gun, Saitama, 350-0495

  • Kanazawa University Hospital ( Site 0354)

    Kanazawa, Ishikawa-ken, 920-8641

  • Nara Medical University Hospital ( Site 0359)

    Kashihara, Nara, 634-8522

  • National Cancer Center Hospital East ( Site 0347)

    Kashiwa, Chiba, 277-8577

  • Toranomon Hospital Kajigaya ( Site 0369)

    Kawasaki, Kanagawa, 213-8587

  • Kumamoto University Hospital ( Site 0372)

    Kumamoto, 860-8556

  • Kurume University Hospital ( Site 0362)

    Kurume, Fukuoka, 830-0011

  • University Hospital,Kyoto Prefectural University of Medicine ( Site 0367)

    Kyoto, 602-8566

  • Osaka International Cancer Institute ( Site 0357)

    Osaka, 541-8567

  • Japanese Red Cross Osaka Hospital ( Site 0356)

    Osaka, 543-8555

  • Saga-Ken Medical Centre Koseikan ( Site 0363)

    Saga, 840-8571

  • Sapporo Kosei General Hospital ( Site 0345)

    Sapporo, Hokkaido, 060-0033

  • Kindai University Hospital ( Site 0358)

    Sayama, Osaka, 589-8511

  • Jichi Medical University Hospital ( Site 0353)

    Shimotsuke, Tochigi, 329-0498

  • Shizuoka Cancer Center ( Site 0365)

    Suntogun, Shizuoka, 411-8777

  • Kagawa Prefectural Central Hospital ( Site 0364)

    Takamatsu, Kagawa-ken, 760-8557

  • Toranomon Hospital ( Site 0349)

    Tokyo, 105-8470

  • Juntendo University Hospital ( Site 0371)

    Tokyo, 113-0033

  • The University of Tokyo Hospital ( Site 0348)

    Tokyo, 113-8655

  • Ehime University Hospital ( Site 0368)

    Tōon, Ehime, 791-0295

  • Yokohama City University Medical Center ( Site 0351)

    Yokohama, Kanagawa, 232-0024

  • Kanagawa Cancer Center ( Site 0352)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

South Korea10 sites

  • Pusan National University Hospital ( Site 0568)

    Busan, Pusan-Kwangyokshi, 49241

  • Kyungpook National University Hospital ( Site 0569)

    Daegu, Taegu-Kwangyokshi, 41944

  • Chonnam National University Hwasun Hospital ( Site 0572)

    Hwasun, Jeonranamdo, 58128

  • Seoul National University Bundang Hospital ( Site 0570)

    Seongnam-si, Kyonggi-do, 13620

  • Seoul National University Hospital ( Site 0567)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 0564)

    Seoul, 03722

  • Asan Medical Center ( Site 0565)

    Seoul, 05505

  • Samsung Medical Center ( Site 0566)

    Seoul, 06351

  • The Catholic University of Korea St. Mary s Hospital ( Site 0571)

    Seoul, 06591

  • Korea University Guro Hospital ( Site 0573)

    Seoul, 08308

Other trials in South Korea

Germany9 sites

  • Charite - Universitaetsmedizin ( Site 0204)

    Berlin, 13353

  • Universitaetsklinikum Bonn ( Site 0203)

    Bonn, North Rhine-Westphalia, 53127

  • Krankenhaus Nord-West GmbH ( Site 0208)

    Frankfurt am Main, Hesse, 60488

  • Universitaetsklinikum Freiburg ( Site 0199)

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitaetsklinikum Halle ( Site 0213)

    Halle, Saxony-Anhalt, 06120

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)

    Hamburg, 20246

  • Medizinische Hochschule Hannover ( Site 0200)

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Leipzig ( Site 0202)

    Leipzig, Saxony, 04103

  • Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)

    Lübeck, Schleswig-Holstein, 23538

Other trials in Germany

Italy9 sites

  • Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)

    Brescia, 25123

  • AOU Policlinico G. Martino ( Site 0324)

    Messina, Sicily, 98124

  • ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)

    Milan, Milano, 20162

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)

    Milan, 20122

  • Ospedale del Mare ( Site 0327)

    Naples, Campania, 80147

  • Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)

    Naples, 80131

  • Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)

    Ravenna, 48121

  • Policlinico Universitario -Agostino Gemelli ( Site 0328)

    Roma, 00168

  • Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)

    Turin, Piedmont, 10128

Other trials in Italy

Brazil8 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)

    Barretos, São Paulo, 14784-400

  • Clinica de Oncologia Reichow ( Site 0052)

    Blumenau, Santa Catarina, 89010-340

  • Fundacao Dr Amaral Carvalho ( Site 0050)

    Jaú, São Paulo, 17210-120

  • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057)

    Natal, Rio Grande do Norte, 59075-740

  • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital de Base de Sao Jose de Rio Preto ( Site 0043)

    São José do Rio Preto, São Paulo, 15090-000

  • BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)

    São Paulo, São Paulo, 01323-001

  • A.C. Camargo Cancer Center ( Site 0054)

    São Paulo, 01509-900

Other trials in Brazil

Taiwan8 sites

  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)

    Kaohsiung City, Kaohsiung, 833

  • Kaohsiung Medical University Hospital ( Site 0611)

    Kaohsiung City, 807

  • China Medical University Hospital-Surgical Department ( Site 0610)

    Taichung, 40447

  • Taichung Veterans General Hospital ( Site 0613)

    Taichung, 407

  • National Cheng Kung University Hospital ( Site 0608)

    Tainan, 70457

  • National Taiwan University Hospital ( Site 0606)

    Taipei, 10002

  • Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine ( Site 0612)

    Taipei, 112201

  • Chang Gung Medical Foundation. Linkou ( Site 0607)

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)8 sites

  • Hacettepe University Medical Faculty ( Site 0653)

    Ankara, 06230

  • Ankara City Hospital-Medical Oncology ( Site 0661)

    Ankara, 06800

  • Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)

    Edirne, 22030

  • Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)

    Istanbul, 34093

  • Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)

    Izmir, 35100

  • I.E.U. Medical Point Hastanesi ( Site 0649)

    Izmir, 35575

  • Konya Necmettin Erbakan University Medical Faculty ( Site 0652)

    Konya, 42080

  • Inonu Universitesi Medical Fakultesi ( Site 0650)

    Malatya, 44280

Other trials in Turkey (Türkiye)

Australia6 sites

  • Princess Alexandra Hospital ( Site 0006)

    Brisbane, Queensland, 4102

  • Austin Health ( Site 0008)

    Heidelberg, Victoria, 3084

  • St George Hospital ( Site 0005)

    Kogarah, New South Wales, 2217

  • Alfred Health ( Site 0004)

    Melbourne, Victoria, 3004

  • Royal Perth Hospital ( Site 0002)

    Perth, Western Australia, 6000

  • Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)

    Westmead, New South Wales, 2145

Other trials in Australia

France6 sites

  • A.P.H. Paris, Hopital Henri Mondor ( Site 0179)

    Créteil, Val-de-Marne, 94000

  • Hopital de la Croix-Rousse ( Site 0193)

    Lyon, Auvergne, 69004

  • Hopital de la Timone ( Site 0188)

    Marseille, Bouches-du-Rhone, 13005

  • CHU Bordeaux Haut-Leveque ( Site 0185)

    Pessac, Gironde, 33604

  • C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

  • Hopital Paul Brousse ( Site 0182)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Spain6 sites

  • Hospital General Universitario Gregorio Maranon ( Site 0598)

    Madrid, 28007

  • Hospital Ramon y Cajal ( Site 0593)

    Madrid, 28034

  • Hospital Clinico San Carlos ( Site 0597)

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro ( Site 0596)

    Majadahonda, Madrid, 28222

  • Hospital Virgen del Rocio ( Site 0591)

    Seville, 41013

  • Hospital General Universitario de Valencia ( Site 0595)

    Valencia, Valenciana, Comunitat, 46014

Other trials in Spain

Israel5 sites

  • Emek Medical Center ( Site 0307)

    Afula, 1834111

  • Rambam Health Care Campus-Oncology Division ( Site 0305)

    Haifa, 3109601

  • Hadassah Ein Karem Jerusalem ( Site 0303)

    Jerusaelm, 9112001

  • Rabin Medical Center ( Site 0304)

    Petah Tikva, 4941 492

  • Sourasky Medical Center ( Site 0306)

    Tel Aviv, 6423906

Other trials in Israel

Netherlands5 sites

  • AMC ( Site 0438)

    Amsterdam, North Holland, 1105 AZ

  • Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)

    Leiden, South Holland, 2333 ZA

  • Maastricht University Medical Centre ( Site 0440)

    Maastricht, Limburg, 6229 HX

  • Erasmus University Medical Center ( Site 0439)

    Rotterdam, South Holland, 3015 GD

  • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)

    Utrecht, 3584 CX

Other trials in Netherlands

Portugal5 sites

  • Centro Hospitalar e Universitario de Coimbra ( Site 0502)

    Coimbra, 3000-075

  • Unidade Local de Saude de São José - Hospital de Santo Antonio dos Capuchos ( Site 0505)

    Lisbon, 1169-050

  • Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)

    Porto, 4099-001

  • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)

    Porto, 4200-072

  • Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)

    Porto, 4200-319

Other trials in Portugal

Chile4 sites

  • Centro de Oncología de Precisión-Oncology ( Site 0068)

    Santiago, Region M. de Santiago, 7560908

  • Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)

    Santiago, Region M. de Santiago, 8330024

  • Bradfordhill ( Site 0066)

    Santiago, Region M. de Santiago, 8420383

  • Centro Investigación del Cáncer James Lind ( Site 0064)

    Temuco, Araucania, 4800827

Other trials in Chile

Colombia4 sites

  • Administradora Country S.A. ( Site 0137)

    Bogotá, Bogota D.C., 110221

  • Fundación Valle del Lili ( Site 0140)

    Cali, Valle del Cauca Department, 760032

  • Hospital Pablo Tobon Uribe ( Site 0145)

    Medellín, Antioquia, 050034

  • Fundacion Cardiovascular de Colombia ( Site 0136)

    Piedecuesta, Santander Department, 681017

Other trials in Colombia

Puerto Rico4 sites

  • Puerto Rico Medical Research Center LLC ( Site 0523)

    Hato Rey, 00917

  • Ad-Vance Medical Research LLC ( Site 0527)

    Ponce, 00717

  • VA Caribbean Healthcare System ( Site 0524)

    San Juan, 00921-3201

  • FDI Clinical Research ( Site 0522)

    San Juan, 00927

Other trials in Puerto Rico

Denmark3 sites

  • Aarhus Universitets hospital ( Site 0175)

    Aarhus N, Central Jutland, 8200

  • Herlev Hospital ( Site 0170)

    Herlev, Capital Region, 2730

  • Odense Universitetshospital ( Site 0160)

    Odense, Region Syddanmark, 5000

Other trials in Denmark

Hungary3 sites

  • Semmelweis University ( Site 0264)

    Budapest, 1085

  • Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)

    Kaposvár, Somogy County, 7400

  • Zala Megyei Szent Rafael Korhaz ( Site 0265)

    Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Thailand3 sites

  • Chulalongkorn University ( Site 0627)

    Bangkok, Bangkok, 10330

  • Ramathibodi Hospital, Mahidol University ( Site 0628)

    Bangkok, Bangkok, 10400

  • Faculty of Medicine Siriraj Hospital ( Site 0629)

    Bangkok, Bangkok, 10700

Other trials in Thailand

United Kingdom3 sites

  • Barts Health NHS Trust ( Site 0692)

    London, London, City of, EC1A 7BE

  • Royal Marsden NHS Foundation Trust ( Site 0694)

    London, London, City of, SW3 6JJ

  • Royal Marsden NHS Trust ( Site 0693)

    Sutton, London, City of, SM2 5PT

Other trials in United Kingdom

Hong Kong1 site

  • Prince of Wales Hospital ( Site 0242)

    Shatin

Other trials in Hong Kong

Ireland1 site

  • St Vincents University Hospital ( Site 0690)

    Dublin, D04 T6F4

Other trials in Ireland

New Zealand1 site

  • Auckland City Hospital ( Site 0459)

    Auckland, 1023

Other trials in New Zealand

Norway1 site

  • Oslo Universitetssykehus Ullevål ( Site 0500)

    Oslo, 0450

Other trials in Norway

Ukraine1 site

  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)

    Kharkiv, Kharkiv Oblast, 61070

Other trials in Ukraine

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)

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).

Being tested
Lenvatinib, Pembrolizumab, Oral Placebo, IV Placebo, TACE
Keywords
receptor tyrosine kinase inhibitor, programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1)
Medical subject headings
Carcinoma, Hepatocellular, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

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

  • LenvatinibDrug

    Also called MK-7902, E7080, LENVIMA®

    Administered 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.

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).

  • Oral PlaceboDrug

    Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.

  • IV PlaceboDrug

    Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).

  • TACEProcedure or surgery

    Conducted as a background procedure of chemotherapeutic and embolic agent(s).

Study groups in NCT04246177
Study groupRoleWhat they receive
Lenvatinib plus Pembrolizumab plus TACEExperimentalParticipants 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).
Receives: Drug: Lenvatinib; Biological: Pembrolizumab; Procedure: TACE
Oral Placebo plus IV Placebo plus TACEActive 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).
Receives: Drug: Oral Placebo; Drug: IV Placebo; Procedure: TACE

What is being measured

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

  1. Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    PFS was defined as the time from the first dose of study intervention to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 as assessed by BICR was reported.

    Measured: Up to approximately 43.5 Months

  2. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 61.7 Months

Secondary outcomes (13)

  1. PFS Per Modified RECIST (mRECIST) as Assessed by BICR

    PFS was defined as the time from the first dose of study intervention to the first documented PD per mRECIST by BICR or death due to any cause, whichever occurs first. mRECIST for hepatocellular carcinoma (HCC) allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable target lesions, taking as reference the smallest SODs of viable target lesions recorded since the treatment started. PFS per mRECIST as assessed by BICR was reported.

    Measured: Up to approximately 61.7 Months

  2. Objective Response Rate (ORR) Per mRECIST as Assessed by BICR

    ORR was defined as the percentage of participants who achieve a confirmed complete response (CR) (disappearance of any intratumoral arterial enhancement in all target lesions) or a partial response (PR) (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. The percentage of participants who experienced CR or PR per mRECIST as assessed BICR was presented.

    Measured: Up to approximately 61.7 Months

  3. Disease Control Rate (DCR) Per mRECIST as Assessed by BICR

    DCR was defined as the percentage of participants who have achieved a confirmed complete response (CR) (disappearance of any intratumoral arterial enhancement in all target lesions) or a partial response (PR) (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per mRECIST assessed by BICR was presented.

    Measured: Up to approximately 61.7 Months

  4. Duration of Response (DOR) Per mRECIST as Assessed by BICR

    For participants who demonstrated confirmed CR or PR per mRECIST assessed by BICR, DOR was defined as the time from the first documented evidence of a confirmed complete response (CR) (disappearance of any intratumoral arterial enhancement in all target lesions) or a partial response (PR) (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed using mRECIST for all participants who experienced a confirmed CR or PR was presented.

    Measured: Up to approximately 61.7 Months

  5. Time-To-Progression (TTP) Per mRECIST as Assessed by BICR

    TTP was defined as the time from the first dose of study intervention to the first documented PD per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. TTP per mRECIST as assessed by BICR was presented.

    Measured: Up to approximately 61.7 Months

  6. Number of Participants Who Experienced At Least One Adverse Event (AE)

    An AE will be any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.

    Measured: Up to approximately 71.1 Months

  7. Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE)

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. The number of participants with an SAE was reported.

    Measured: Up to approximately 71.1 Months

  8. Number of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI)

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Hepatic events of clinical interest (ECIs) included any of the following events if the event was considered not due to disease progression as judged by the investigator: among participants with Baseline ALT <2 × ULN: ALT ≥5 × ULN; among participants with Baseline ALT ≥2 × ULN: ALT >3 × the Baseline level; ALT >500 U/L regardless of baseline level; total bilirubin >3.0 mg/dL; hepatic decompensation diagnosed clinically (regardless of laboratory values) including new onset clinically detectable ascites requiring intervention for >3 days, hepatic encephalopathy, or gastrointestinal bleeding suggestive of portal hypertension. The number of participants with a hepatic AE of clinical interest was reported.

    Measured: Up to approximately 71.1 Months

  9. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported.

    Measured: Up to approximately 71.1 Months

  10. ORR Per RECIST 1.1 as Assessed by BICR

    ORR was defined as the percentage of participants who achieve a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ, and assessed by BICR. The percentage of participants who experienced CR or PR per RECIST 1.1 as assessed BICR was presented.

    Measured: Up to approximately 61.7 Months

  11. DCR Per RECIST 1.1 as Assessed by BICR

    DCR was defined as the percentage of participants who have achieved CR (disappearance of all target lesions), PR (at least a 30% decrease in the SOD of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) after ≥6 weeks (the start of the window for the first scheduled scan) per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per RECIST 1.1 assessed by BICR was presented.

    Measured: Up to approximately 61.7 Months

  12. DOR Per RECIST 1.1 as Assessed by BICR

    For participants who demonstrated confirmed CR or PR per RECIST 1.1 assessed by BICR, DOR was defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.

    Measured: Up to approximately 61.7 Months

  13. TTP Per RECIST 1.1 as Assessed by BICR

    TTP was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. TTP per RECIST 1.1 as assessed by BICR was presented.

    Measured: Up to approximately 61.7 Months

Timeline

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

  1. First posted29 Jan 2020
  2. Study start22 May 2020
  3. Primary completion19 Aug 2025
  4. Study completion26 Mar 2026

Why it stopped: Business Reasons

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04246177
Sponsor's protocol ID
7902-012
Other IDs
MK-7902-012, LEAP-012, E7080-G000-318, 205286, 2022-502116-36-00, U1111-1283-3439, 2019-002345-37, 2019
Status last verified
Sep 2026
First submitted
27 Jan 2020
Last updated
3 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 39798578

  • 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.

    PubMed 35421228

  • 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.

    PubMed 35119481

  • 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.

    PubMed 33300372

  • 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.

    PubMed 32557715

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenvatinib, Pembrolizumab and TACE in people with Carcinoma, Hepatocellular, run by Merck Sharp & Dohme LLC at 205 sites in 27 countries.

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

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in China, United States, Japan, South Korea, Germany and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to approximately 43.5 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04246177, which also lists 5 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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