CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 794 enrolled
Drug / intervention
lenvatinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03713593
NCT03713593Phase 3Completed
CompareCT.gov

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)

Merck Sharp & Dohme LLC·interventional·Posted Oct 22, 2018·Updated Feb 5, 2026

In Brief

A Phase 3 clinical trial evaluating lenvatinib, pembrolizumab, and 1 other intervention for Carcinoma, Hepatocellular. Completed, enrolled 794 participants across 172 sites in 21 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesAustralia, Canada, Chile, China, Colombia, France, Germany, Ireland, Italy, Japan, Mexico, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
CollaboratorsEisai Inc.

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 22, 2018
Enrollment StartDec 31, 2018
Primary CompletionJun 21, 2022
Study CompletionSep 24, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.7 years ago

Interventions

lenvatinibdrug

Administered orally once a day

pembrolizumabbiological

Administered as an IV infusion on Day 1 Q3W

saline placebodrug

Administered as an IV infusion on Day 1 Q3W