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)

NCT04246177 PHASE3 COMPLETED

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).

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	PHASE3
Status	COMPLETED
Enrolment	479
Start date	Fri May 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Carcinoma, Hepatocellular

Interventions

• Lenvatinib
• Pembrolizumab
• Oral Placebo
• IV Placebo
• TACE

Countries

South Korea, Ireland, United States, New Zealand, Hungary, Taiwan, Germany, Puerto Rico, Spain, France, United Kingdom, Brazil, Netherlands, Portugal, Turkey (Türkiye), Chile, Italy, Colombia, Hong Kong, Denmark, Australia, Israel, Ukraine, Norway, Japan, China, Thailand