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)
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).
Inclusion Criteria:
Exclusion Criteria:
Albuquerque, New Mexico 87106, United States
Westmead, New South Wales 2145, Australia
Natal, Rio Grande do Norte 59075-740, Brazil
Porto Alegre, Rio Grande do Sul 91350-200, Brazil
Barretos, São Paulo 14784-400, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Santiago, Region M. de Santiago 7560908, Chile
Santiago, Region M. de Santiago 8330024, Chile
Heifei, Anhui 230001, China
Chongqing, Chongqing Municipality 400042, China
Chongqing, Chongqing Municipality 404000, China
Fuzhou, Fujian 350008, China
Zhuhai, Guangdong 519000, China
Nanning, Guangxi 530021, China
Shanghai, Shanghai Municipality 200028, China
Tianjin, Tianjin Municipality 300060, China
Hangzhou, Zhejiang 310009, China
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54500, France
Lübeck, Schleswig-Holstein 23538, Germany
Kaposvár, Somogy County 7400, Hungary
Jerusaelm, 9112001, Israel
Iruma-gun, Saitama 350-0495, Japan
Suntogun, Shizuoka 411-8777, Japan
Leiden, South Holland 2333 ZA, Netherlands
Lisbon, 1169-050, Portugal
Porto, 4099-001, Portugal
Hato Rey, 00917, Puerto Rico
Taipei, 112201, Taiwan
Edirne, 22030, Turkey (Türkiye)
Izmir, 35100, Turkey (Türkiye)
Kharkiv, Kharkiv Oblast 61070, Ukraine