Sikkerhed og effekt af Lenvatinib (E7080/MK-7902) med Pembrolizumab (MK-3475) i kombination med transarteriel kemoembolisering (TACE) hos deltagere med uhelbredeligt/ikke-metastatisk hepatocellulært karcinom (MK-7902-0803-G7902-0803-G7902-0803-G7902-0803-G7902-0801-E LEAP-012)
1. september 2026 opdateret af: Merck Sharp & Dohme LLC
Et fase 3 multicenter, randomiseret, dobbeltblindet, aktivt kontrolleret, klinisk studie til evaluering af sikkerheden og effektiviteten af Lenvatinib (E7080/MK-7902) med Pembrolizumab (MK-3475) i kombination med transarteriel kemoembolisering (TACE i TACE) versus TACE Deltagere med uhelbredelig/ikke-metastatisk hepatocellulært karcinom (LEAP-012)
Formålet med denne undersøgelse er at evaluere effektiviteten og sikkerheden af lenvatinib og pembrolizumab i kombination med TACE versus TACE plus oral og intravenøs (IV) placebo hos deltagere med uhelbredelig, ikke-metastatisk hepatocellulært carcinom (HCC).
De primære hypoteser er, at pembrolizumab plus lenvatinib i kombination med TACE er bedre end placebo plus TACE med hensyn til progressionsfri overlevelse (PFS) og total overlevelse (OS).
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
480
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Kogarah, New South Wales, Australien, 2217
- St George Hospital ( Site 0005)
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Westmead, New South Wales, Australien, 2145
- Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)
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Queensland
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Brisbane, Queensland, Australien, 4102
- Princess Alexandra Hospital ( Site 0006)
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Victoria
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Heidelberg, Victoria, Australien, 3084
- Austin Health ( Site 0008)
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Melbourne, Victoria, Australien, 3004
- Alfred Health ( Site 0004)
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Western Australia
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Perth, Western Australia, Australien, 6000
- Royal Perth Hospital ( Site 0002)
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São Paulo, Brasilien, 01509-900
- A.C. Camargo Cancer Center ( Site 0054)
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasilien, 59075-740
- Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057)
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 91350-200
- Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056)
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Santa Catarina
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Blumenau, Santa Catarina, Brasilien, 89010-340
- Clinica de Oncologia Reichow ( Site 0052)
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São Paulo
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Barretos, São Paulo, Brasilien, 14784-400
- Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)
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Jaú, São Paulo, Brasilien, 17210-120
- Fundacao Dr Amaral Carvalho ( Site 0050)
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São José do Rio Preto, São Paulo, Brasilien, 15090-000
- Hospital de Base de Sao Jose de Rio Preto ( Site 0043)
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São Paulo, São Paulo, Brasilien, 01323-001
- BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)
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Araucania
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Temuco, Araucania, Chile, 4800827
- Centro Investigación del Cáncer James Lind ( Site 0064)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7560908
- Centro de Oncología de Precisión-Oncology ( Site 0068)
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Santiago, Region M. de Santiago, Chile, 8330024
- Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)
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Santiago, Region M. de Santiago, Chile, 8420383
- Bradfordhill ( Site 0066)
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Antioquia
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Medellín, Antioquia, Colombia, 050034
- Hospital Pablo Tobon Uribe ( Site 0145)
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 110221
- Administradora Country S.A. ( Site 0137)
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Santander Department
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Piedecuesta, Santander Department, Colombia, 681017
- Fundacion Cardiovascular de Colombia ( Site 0136)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760032
- Fundación Valle del Lili ( Site 0140)
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Capital Region
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Herlev, Capital Region, Danmark, 2730
- Herlev Hospital ( Site 0170)
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Central Jutland
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Aarhus N, Central Jutland, Danmark, 8200
- Aarhus Universitets hospital ( Site 0175)
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Region Syddanmark
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Odense, Region Syddanmark, Danmark, 5000
- Odense Universitetshospital ( Site 0160)
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London, City of
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London, London, City of, Det Forenede Kongerige, EC1A 7BE
- Barts Health NHS Trust ( Site 0692)
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London, London, City of, Det Forenede Kongerige, SW3 6JJ
- Royal Marsden NHS Foundation Trust ( Site 0694)
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Sutton, London, City of, Det Forenede Kongerige, SM2 5PT
- Royal Marsden NHS Trust ( Site 0693)
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Arizona
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Tucson, Arizona, Forenede Stater, 85711
- Arizona Oncology Associates PC- HOPE ( Site 0770)
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California
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La Jolla, California, Forenede Stater, 92037
- Scripps Clinic Torrey Pines ( Site 0714)
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Los Angeles, California, Forenede Stater, 90033
- USC Norris Comprehensive Cancer Center ( Site 0717)
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Los Angeles, California, Forenede Stater, 90404
- UCLA Hematology/Oncology - Santa Monica ( Site 0720)
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Orange, California, Forenede Stater, 92868
- UC Irvine Health ( Site 0718)
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Yale Cancer Center ( Site 0724)
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Florida
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Tampa, Florida, Forenede Stater, 33606
- Tampa General Hospital ( Site 0764)
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Idaho
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Boise, Idaho, Forenede Stater, 83712
- Mountain States Tumor Institute ( Site 0773)
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospital and Clinics ( Site 0729)
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Kansas
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Westwood, Kansas, Forenede Stater, 66205
- University of Kansas Cancer Center ( Site 0731)
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- University of Louisville ( Site 0757)
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane Medical Center ( Site 0787)
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New Orleans, Louisiana, Forenede Stater, 70112
- University Medical Center New Orleans ( Site 0733)
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital-GI/Hepatology Research ( Site 0735)
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Saint Louis University ( Site 0769)
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87106
- University of New Mexico Comprehensive Cancer Center ( Site 0805)
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New York
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Lake Success, New York, Forenede Stater, 11042
- Monter Cancer Center ( Site 0780)
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New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai ( Site 0744)
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest Baptist Health ( Site 0741)
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- University of Cincinnati Medical Center ( Site 0791)
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Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University Wexner Medical Center ( Site 0759)
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Sylvania, Ohio, Forenede Stater, 43560
- ProMedica Flower Hospital ( Site 0796)
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Stephenson Cancer Center ( Site 0745)
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- OHSU Center for Health & Healing ( Site 0746)
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Penn State Hershey Medical Center ( Site 0766)
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Texas
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Houston, Texas, Forenede Stater, 77030
- Houston Methodist Research Institute ( Site 0784)
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West Virginia
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Huntington, West Virginia, Forenede Stater, 25701
- Edwards Comprehensive Cancer Center ( Site 0786)
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Auvergne
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Lyon, Auvergne, Frankrig, 69004
- Hopital de la Croix-Rousse ( Site 0193)
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Bouches-du-Rhone
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Marseille, Bouches-du-Rhone, Frankrig, 13005
- Hopital de la Timone ( Site 0188)
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Gironde
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Pessac, Gironde, Frankrig, 33604
- CHU Bordeaux Haut-Leveque ( Site 0185)
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Meurthe-et-Moselle
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Frankrig, 54500
- C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)
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Val-de-Marne
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Créteil, Val-de-Marne, Frankrig, 94000
- A.P.H. Paris, Hopital Henri Mondor ( Site 0179)
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Villejuif, Val-de-Marne, Frankrig, 94800
- Hopital Paul Brousse ( Site 0182)
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Utrecht, Holland, 3584 CX
- Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)
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Limburg
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Maastricht, Limburg, Holland, 6229 HX
- Maastricht University Medical Centre ( Site 0440)
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North Holland
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Amsterdam, North Holland, Holland, 1105 AZ
- AMC ( Site 0438)
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South Holland
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Leiden, South Holland, Holland, 2333 ZA
- Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)
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Rotterdam, South Holland, Holland, 3015 GD
- Erasmus University Medical Center ( Site 0439)
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Shatin, Hong Kong
- Prince of Wales Hospital ( Site 0242)
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Dublin, Irland, D04 T6F4
- St Vincents University Hospital ( Site 0690)
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Afula, Israel, 1834111
- Emek Medical Center ( Site 0307)
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Haifa, Israel, 3109601
- Rambam Health Care Campus-Oncology Division ( Site 0305)
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Jerusaelm, Israel, 9112001
- Hadassah Ein Karem Jerusalem ( Site 0303)
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Petah Tikva, Israel, 4941 492
- Rabin Medical Center ( Site 0304)
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center ( Site 0306)
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Brescia, Italien, 25123
- Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)
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Milan, Italien, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)
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Naples, Italien, 80131
- Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)
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Ravenna, Italien, 48121
- Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)
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Roma, Italien, 00168
- Policlinico Universitario -Agostino Gemelli ( Site 0328)
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Campania
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Naples, Campania, Italien, 80147
- Ospedale del Mare ( Site 0327)
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Milano
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Milan, Milano, Italien, 20162
- ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)
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Piedmont
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Turin, Piedmont, Italien, 10128
- Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)
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Sicily
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Messina, Sicily, Italien, 98124
- AOU Policlinico G. Martino ( Site 0324)
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Chiba, Japan, 260-8677
- Chiba University Hospital ( Site 0346)
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Fukuoka, Japan, 8108563
- National Hospital Organization Kyushu Medical Center ( Site 0361)
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Hiroshima, Japan, 734-8551
- Hiroshima University Hospital ( Site 0360)
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Kumamoto, Japan, 860-8556
- Kumamoto University Hospital ( Site 0372)
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Kyoto, Japan, 602-8566
- University Hospital,Kyoto Prefectural University of Medicine ( Site 0367)
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Osaka, Japan, 541-8567
- Osaka International Cancer Institute ( Site 0357)
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Osaka, Japan, 543-8555
- Japanese Red Cross Osaka Hospital ( Site 0356)
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Saga, Japan, 840-8571
- Saga-Ken Medical Centre Koseikan ( Site 0363)
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Tokyo, Japan, 105-8470
- Toranomon Hospital ( Site 0349)
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Tokyo, Japan, 113-0033
- Juntendo University Hospital ( Site 0371)
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Tokyo, Japan, 113-8655
- The University of Tokyo Hospital ( Site 0348)
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center Hospital East ( Site 0347)
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Ehime
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Tōon, Ehime, Japan, 791-0295
- Ehime University Hospital ( Site 0368)
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Fukuoka
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Kurume, Fukuoka, Japan, 830-0011
- Kurume University Hospital ( Site 0362)
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-0033
- Sapporo Kosei General Hospital ( Site 0345)
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japan, 920-8641
- Kanazawa University Hospital ( Site 0354)
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Kagawa-ken
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Takamatsu, Kagawa-ken, Japan, 760-8557
- Kagawa Prefectural Central Hospital ( Site 0364)
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Kanagawa
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Kawasaki, Kanagawa, Japan, 213-8587
- Toranomon Hospital Kajigaya ( Site 0369)
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Yokohama, Kanagawa, Japan, 232-0024
- Yokohama City University Medical Center ( Site 0351)
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Yokohama, Kanagawa, Japan, 241-8515
- Kanagawa Cancer Center ( Site 0352)
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Nara
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Kashihara, Nara, Japan, 634-8522
- Nara Medical University Hospital ( Site 0359)
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Osaka
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Sayama, Osaka, Japan, 589-8511
- Kindai University Hospital ( Site 0358)
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Saitama
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Iruma-gun, Saitama, Japan, 350-0495
- Saitama Medical University Hospital ( Site 0370)
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Shizuoka
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Suntogun, Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center ( Site 0365)
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Tochigi
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Shimotsuke, Tochigi, Japan, 329-0498
- Jichi Medical University Hospital ( Site 0353)
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Anhui
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Heifei, Anhui, Kina, 230001
- Anhui Provincial Hospital ( Site 0092)
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Beijing Cancer Hospital ( Site 0099)
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Beijing, Beijing Municipality, Kina, 100142
- Beijing Cancer Hospital ( Site 0105)
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Beijing, Beijing Municipality, Kina, 100730
- Peking Union Medical College Hospital ( Site 0087)
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400042
- Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)
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Chongqing, Chongqing Municipality, Kina, 404000
- Chongqing University Three Gorges Hospital ( Site 0859)
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Fujian
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Fuzhou, Fujian, Kina, 350014
- Fujian Provincial Cancer Hospital ( Site 0085)
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Fuzhou, Fujian, Kina, 350014
- The First Affiliated Hospital of Fujian Medical University ( Site 0089)
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Fuzhou, Fujian, Kina, 350008
- Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)
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Xiamen, Fujian, Kina, 361015
- Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)
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Guangdong
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Guangzhou, Guangdong, Kina, 510000
- Zhujiang Hospital of Southern Medical University ( Site 0115)
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Guangzhou, Guangdong, Kina, 510080
- Guangdong Provincial People s Hospital ( Site 0100)
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Guangzhou, Guangdong, Kina, 510515
- NANFANG HOSPITAL SOUTHERN MEDICAL UNIVERSITY ( Site 0088)
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Guangzhou, Guangdong, Kina, 510700
- SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0128)
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Zhuhai, Guangdong, Kina, 519000
- Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)
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Guangxi
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Nanning, Guangxi, Kina, 530021
- Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)
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Hainan
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Haikou, Hainan, Kina, 570311
- Hainan General Hospital ( Site 0112)
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150081
- Harbin Medical University Cancer Hospital ( Site 0090)
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Henan
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Zhengzhou, Henan, Kina, 450008
- Henan Cancer Hospital ( Site 0114)
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Hubei
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Wuhan, Hubei, Kina, 430079
- Hubei Cancer Hospital ( Site 0101)
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Wuhan, Hubei, Kina, 430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)
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Hunan
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Changsha, Hunan, Kina, 410005
- Hunan Provincial People's Hospital ( Site 0113)
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Changsha, Hunan, Kina, 410013
- Hunan Cancer Hospital ( Site 0096)
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Jiangsu
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Suzhou, Jiangsu, Kina, 215006
- The First Affiliated Hospital of Soochow University ( Site 0120)
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Jiangxi
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Nanchang, Jiangxi, Kina, 330029
- Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)
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Shaanxi
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Xi'an, Shaanxi, Kina, 710100
- Xi'an International Medical Center Hospital ( Site 0860)
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200028
- The Third Affiliated Hospital of the PLA Navy Medical University ( Site 0123)
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Shanghai, Shanghai Municipality, Kina, 200032
- Fudan University Shanghai Cancer Center ( Site 0106)
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Shanghai, Shanghai Municipality, Kina, 200032
- Zhongshan Hospital Fudan University ( Site 0084)
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Shanxi
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Xi’an, Shanxi, Kina, 710048
- The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- West China Hospital of Sichuan University ( Site 0119)
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Suining, Sichuan, Kina, 629000
- Suining Central Hospital ( Site 0857)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300060
- Tianjin Medical University Cancer Institute & Hospital ( Site 0098)
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Tianjin, Tianjin Municipality, Kina, 300170
- Tianjin Third Central Hospital ( Site 0861)
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Yunnan
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Kunming, Yunnan, Kina, 650200
- The First Hospital of Kunming ( Site 0124)
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310009
- 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)
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Hangzhou, Zhejiang, Kina, 310018
- Sir Run Run Shaw Hospital ( Site 0094)
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Hangzhou, Zhejiang, Kina, 310022
- Zhejiang Cancer Hospital ( Site 0103)
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Ningbo, Zhejiang, Kina, 315048
- Ningbo Medical Center LiHuili Hospital ( Site 0132)
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Auckland, New Zealand, 1023
- Auckland City Hospital ( Site 0459)
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-
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Oslo, Norge, 0450
- Oslo Universitetssykehus Ullevål ( Site 0500)
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Coimbra, Portugal, 3000-075
- Centro Hospitalar e Universitario de Coimbra ( Site 0502)
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Lisbon, Portugal, 1169-050
- Unidade Local de Saude de São José - Hospital de Santo Antonio dos Capuchos ( Site 0505)
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Porto, Portugal, 4099-001
- Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)
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Porto, Portugal, 4200-072
- Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)
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Porto, Portugal, 4200-319
- Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)
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Hato Rey, Puerto Rico, 00917
- Puerto Rico Medical Research Center LLC ( Site 0523)
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Ponce, Puerto Rico, 00717
- Ad-Vance Medical Research LLC ( Site 0527)
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San Juan, Puerto Rico, 00921-3201
- VA Caribbean Healthcare System ( Site 0524)
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San Juan, Puerto Rico, 00927
- FDI Clinical Research ( Site 0522)
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-
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Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Maranon ( Site 0598)
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Madrid, Spanien, 28034
- Hospital Ramon y Cajal ( Site 0593)
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Madrid, Spanien, 28040
- Hospital Clinico San Carlos ( Site 0597)
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Seville, Spanien, 41013
- Hospital Virgen del Rocio ( Site 0591)
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Madrid
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Majadahonda, Madrid, Spanien, 28222
- Hospital Universitario Puerta de Hierro ( Site 0596)
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, Spanien, 46014
- Hospital General Universitario de Valencia ( Site 0595)
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-
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Seoul, Sydkorea, 03080
- Seoul National University Hospital ( Site 0567)
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Seoul, Sydkorea, 03722
- Severance Hospital Yonsei University Health System ( Site 0564)
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Seoul, Sydkorea, 05505
- Asan Medical Center ( Site 0565)
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Seoul, Sydkorea, 06351
- Samsung Medical Center ( Site 0566)
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Seoul, Sydkorea, 06591
- The Catholic University of Korea St. Mary s Hospital ( Site 0571)
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Seoul, Sydkorea, 08308
- Korea University Guro Hospital ( Site 0573)
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Jeonranamdo
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Hwasun, Jeonranamdo, Sydkorea, 58128
- Chonnam National University Hwasun Hospital ( Site 0572)
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Kyonggi-do
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Seongnam-si, Kyonggi-do, Sydkorea, 13620
- Seoul National University Bundang Hospital ( Site 0570)
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Pusan-Kwangyokshi
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Busan, Pusan-Kwangyokshi, Sydkorea, 49241
- Pusan National University Hospital ( Site 0568)
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Taegu-Kwangyokshi
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Daegu, Taegu-Kwangyokshi, Sydkorea, 41944
- Kyungpook National University Hospital ( Site 0569)
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-
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Kaohsiung City, Taiwan, 807
- Kaohsiung Medical University Hospital ( Site 0611)
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Taichung, Taiwan, 40447
- China Medical University Hospital-Surgical Department ( Site 0610)
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Taichung, Taiwan, 407
- Taichung Veterans General Hospital ( Site 0613)
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Tainan, Taiwan, 70457
- National Cheng Kung University Hospital ( Site 0608)
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Taipei, Taiwan, 10002
- National Taiwan University Hospital ( Site 0606)
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Taipei, Taiwan, 112201
- Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine ( Site 0612)
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Taoyuan, Taiwan, 333
- Chang Gung Medical Foundation. Linkou ( Site 0607)
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Kaohsiung
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Kaohsiung City, Kaohsiung, Taiwan, 833
- Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)
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Bangkok
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Bangkok, Bangkok, Thailand, 10330
- Chulalongkorn University ( Site 0627)
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Bangkok, Bangkok, Thailand, 10400
- Ramathibodi Hospital, Mahidol University ( Site 0628)
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Bangkok, Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital ( Site 0629)
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Ankara, Tyrkiet (Türkiye), 06230
- Hacettepe University Medical Faculty ( Site 0653)
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Ankara, Tyrkiet (Türkiye), 06800
- Ankara City Hospital-Medical Oncology ( Site 0661)
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Edirne, Tyrkiet (Türkiye), 22030
- Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)
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Istanbul, Tyrkiet (Türkiye), 34093
- Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)
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Izmir, Tyrkiet (Türkiye), 35100
- Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)
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Izmir, Tyrkiet (Türkiye), 35575
- I.E.U. Medical Point Hastanesi ( Site 0649)
-
Konya, Tyrkiet (Türkiye), 42080
- Konya Necmettin Erbakan University Medical Faculty ( Site 0652)
-
Malatya, Tyrkiet (Türkiye), 44280
- Inonu Universitesi Medical Fakultesi ( Site 0650)
-
-
-
-
-
Berlin, Tyskland, 13353
- Charite - Universitaetsmedizin ( Site 0204)
-
Hamburg, Tyskland, 20246
- Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)
-
-
Baden-Wurttemberg
-
Freiburg im Breisgau, Baden-Wurttemberg, Tyskland, 79106
- Universitaetsklinikum Freiburg ( Site 0199)
-
-
Hesse
-
Frankfurt am Main, Hesse, Tyskland, 60488
- Krankenhaus Nord-West GmbH ( Site 0208)
-
-
Lower Saxony
-
Hanover, Lower Saxony, Tyskland, 30625
- Medizinische Hochschule Hannover ( Site 0200)
-
-
North Rhine-Westphalia
-
Bonn, North Rhine-Westphalia, Tyskland, 53127
- Universitaetsklinikum Bonn ( Site 0203)
-
-
Saxony
-
Leipzig, Saxony, Tyskland, 04103
- Universitaetsklinikum Leipzig ( Site 0202)
-
-
Saxony-Anhalt
-
Halle, Saxony-Anhalt, Tyskland, 06120
- Universitaetsklinikum Halle ( Site 0213)
-
-
Schleswig-Holstein
-
Lübeck, Schleswig-Holstein, Tyskland, 23538
- Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)
-
-
-
-
Kharkiv Oblast
-
Kharkiv, Kharkiv Oblast, Ukraine, 61070
- Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)
-
-
-
-
-
Budapest, Ungarn, 1085
- Semmelweis University ( Site 0264)
-
-
Somogy County
-
Kaposvár, Somogy County, Ungarn, 7400
- Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)
-
-
Zala County
-
Zalaegerszeg, Zala County, Ungarn, 8900
- Zala Megyei Szent Rafael Korhaz ( Site 0265)
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Har en HCC-diagnose bekræftet af radiologi, histologi eller cytologi
- Har HCC lokaliseret til leveren og ikke modtagelig for helbredende behandling
- Deltagere med hepatitis C-virus (HCV) er kvalificerede, hvis behandlingen blev afsluttet mindst 1 måned før start af undersøgelsesintervention
- Deltagere med hepatitis B-virus (HBV) er kvalificerede
- Har tilstrækkeligt kontrolleret blodtryk med eller uden antihypertensiv medicin
- Har tilstrækkelig organfunktion
Ekskluderingskriterier:
- Er i øjeblikket kandidat til levertransplantation
- Har haft maveblødning inden for de sidste 6 måneder
- Har ascites, der ikke kontrolleres med medicin
- Har betydelig kardiovaskulær svækkelse inden for 12 måneder efter den første dosis af undersøgelsesintervention, såsom kongestiv hjertesvigt
- Har et alvorligt ikke-helende sår, mavesår eller knoglebrud
- Har modtaget lokoregional terapi til eksisterende leverlæsioner
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Lenvatinib plus Pembrolizumab plus TACE
Deltagerne vil modtage en kombination af lenvatinib, pembrolizumab og TACE.
Lenvatinib vil blive indgivet i en dosis på 12 mg (for deltagere med screening kropsvægt ≥60 kg) eller 8 mg (for deltagere med screening kropsvægt
|
Indgivet i en dosis på 12 mg (for deltagere med screening kropsvægt ≥60 kg) eller 8 mg (for deltagere med screening kropsvægt
Andre navne:
Administreret via IV infusion i en dosis på 400 mg én gang hver 6. uge (Q6W).
Andre navne:
Udført som baggrundsprocedure for kemoterapeutiske og emboliske midler.
|
|
Aktiv komparator: Oral placebo plus IV Placebo plus TACE
Deltagerne vil modtage en kombination af lenvatinib-matchende oral placebo, pembrolizumab-matchende IV placebo og TACE.
Lenvatinib-matchende oral placebo vil blive administreret én gang dagligt i hver 21-dages cyklus i op til 2 år (~35 cyklusser) eller længere med sponsorgodkendelse, og pembrolizumab-matchende IV placebo vil blive administreret én gang hver 6. uge (Q6W) i op til til 2 år (~17 doser).
Deltagerne vil gennemgå TACE som en baggrundsprocedure for kemoterapeutiske og emboliske midler.
|
Udført som baggrundsprocedure for kemoterapeutiske og emboliske midler.
Lenvatinib-matchende placebo administreret via orale kapsler én gang dagligt i hver 21-dages cyklus.
Pembrolizumab-matchende placebo administreret via IV-infusion én gang hver 6. uge (Q6W).
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
Tidsramme: Up to approximately 43.5 Months
|
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.
|
Up to approximately 43.5 Months
|
|
Overall Survival (OS)
Tidsramme: Up to approximately 61.7 Months
|
OS was defined as the time from randomization to death due to any cause.
|
Up to approximately 61.7 Months
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PFS Per Modified RECIST (mRECIST) as Assessed by BICR
Tidsramme: Up to approximately 61.7 Months
|
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.
|
Up to approximately 61.7 Months
|
|
Objective Response Rate (ORR) Per mRECIST as Assessed by BICR
Tidsramme: Up to approximately 61.7 Months
|
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.
|
Up to approximately 61.7 Months
|
|
Disease Control Rate (DCR) Per mRECIST as Assessed by BICR
Tidsramme: Up to approximately 61.7 Months
|
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.
|
Up to approximately 61.7 Months
|
|
Duration of Response (DOR) Per mRECIST as Assessed by BICR
Tidsramme: Up to approximately 61.7 Months
|
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.
|
Up to approximately 61.7 Months
|
|
Time-To-Progression (TTP) Per mRECIST as Assessed by BICR
Tidsramme: Up to approximately 61.7 Months
|
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.
|
Up to approximately 61.7 Months
|
|
Number of Participants Who Experienced At Least One Adverse Event (AE)
Tidsramme: Up to approximately 71.1 Months
|
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.
|
Up to approximately 71.1 Months
|
|
Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE)
Tidsramme: Up to approximately 71.1 Months
|
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.
|
Up to approximately 71.1 Months
|
|
Number of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI)
Tidsramme: Up to approximately 71.1 Months
|
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.
|
Up to approximately 71.1 Months
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Tidsramme: Up to approximately 71.1 Months
|
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.
|
Up to approximately 71.1 Months
|
|
ORR Per RECIST 1.1 as Assessed by BICR
Tidsramme: Up to approximately 61.7 Months
|
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.
|
Up to approximately 61.7 Months
|
|
DCR Per RECIST 1.1 as Assessed by BICR
Tidsramme: Up to approximately 61.7 Months
|
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.
|
Up to approximately 61.7 Months
|
|
DOR Per RECIST 1.1 as Assessed by BICR
Tidsramme: Up to approximately 61.7 Months
|
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.
|
Up to approximately 61.7 Months
|
|
TTP Per RECIST 1.1 as Assessed by BICR
Tidsramme: Up to approximately 61.7 Months
|
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.
|
Up to approximately 61.7 Months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
22. maj 2020
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
19. august 2025
Studieafslutning (Faktiske)
Studieafslutning
26. marts 2026
Datoer for studieregistrering
Først indsendt
Først indsendt
27. januar 2020
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
27. januar 2020
Først opslået (Faktiske)
Først opslået
29. januar 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
3. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. september 2026
Sidst verificeret
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Leversygdomme
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Neoplasmer i leveren
- Karcinom
- Carcinom, hepatocellulært
- Parkinson Disease 4, Autosomal Dominant Lewy Body
- Antineoplastiske midler, immunologiske
- Immune Checkpoint-hæmmere
- Antineoplastiske midler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Proteinkinasehæmmere
- pembrolizumab
- lenvatinib
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 7902-012
- 2019 (U.S. NIH-bevilling/kontrakt: Chief Medical Office (CMO) Alberta Health Services)
- MK-7902-012 (Anden identifikator: MSD Protocol Number)
- LEAP-012 (Anden identifikator: MSD)
- E7080-G000-318 (Anden identifikator: Eisai Protocol Number)
- 205286 (Registry Identifier: JAPIC-CTI)
- 2019-002345-37 (EudraCT nummer)
- 2022-502116-36-00 (Registry Identifier: EU CT)
- U1111-1283-3439 (Registry Identifier: UTN)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .