A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)
The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants.
The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).
Inclusion Criteria:
Exclusion Criteria:
Tucson, Arizona 85721, United States
Miami, Florida 33136, United States
Stony Brook, New York 11794, United States
Oklahoma City, Oklahoma 73104, United States
Wooloongabba, Queensland 4102, Australia
Beijing, Beijing Municipality 100021, China
Medellín, Antioquia 500515, Colombia
Aviano, 33081, Italy
Kita-gun, Kagawa-ken 761-0793, Japan
Mexico City, Mexico City 14080, Mexico
Bytom, Silesian Voivodeship 41-902, Poland
Koszalin, West Pomeranian Voivodeship 75-581, Poland
Seoul, Seoul-teukbyeolsi [Seoul] 03722, South Korea
Kaoshiung, 807, Taiwan
London, London, City of SE5 9RS, United Kingdom
Birkenhead, CH63 4JY, United Kingdom