NCT03713593

Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 794 (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 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).

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	lenvatinib	Administered orally once a day
BIOLOGICAL	pembrolizumab	Administered as an IV infusion on Day 1 Q3W
DRUG	saline placebo	Administered as an IV infusion on Day 1 Q3W

Timeline

• Start date: 2018-12-31
• Primary completion: 2022-06-21
• Completion: 2024-09-24
• First posted: 2018-10-22
• Last updated: 2026-02-05
• Results posted: 2023-07-24

Locations

172 sites across 21 countries: United States, Australia, Canada, Chile, China, Colombia, France, Germany, Ireland, Italy, Japan, Mexico, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study