CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 131 enrolled
Drug / intervention
Pembrolizumab +2 morebiological
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/NCT04889118
NCT04889118Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants With Advanced Melanoma (LEAP-003)

Merck Sharp & Dohme LLC·interventional·Posted May 17, 2021·Updated Dec 23, 2025

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Lenvatinib, and 1 other intervention for Malignant Melanoma. Completed, enrolled 131 participants across 11 sites.

Detailed Summary

The purpose of the China Extension study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in Chinese participants with no prior systemic therapy for their advanced melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesChina
CollaboratorsEisai Inc.

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMay 17, 2021
Enrollment StartJul 14, 2020
Primary CompletionJan 18, 2023
Study CompletionNov 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.1 years ago

Interventions

Pembrolizumabbiological

IV infusion

Lenvatinibdrug

Oral capsule

Placebo for lenvatinibdrug

Oral capsule