NCT04246177

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 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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). 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).

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Lenvatinib	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.
BIOLOGICAL	Pembrolizumab	Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).
DRUG	Oral Placebo	Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.
DRUG	IV Placebo	Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).
PROCEDURE	TACE	Conducted as a background procedure of chemotherapeutic and embolic agent(s).

Timeline

• Start date: 2020-05-22
• Primary completion: 2025-08-19
• Completion: 2026-03-25
• First posted: 2020-01-29
• Last updated: 2025-12-17

Locations

205 sites across 27 countries: United States, Australia, Brazil, Chile, China, Colombia, Denmark, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Portugal, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study