CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
lenvatinib +1 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/NCT03776136
NCT03776136Phase 2Completed
CompareCT.gov

A Multicenter, Open-label, Phase 2 Trial to Assess the Efficacy and Safety of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Melanoma Previously Exposed to an Anti-PD-1/L1 Agent (LEAP-004)

Merck Sharp & Dohme LLC·interventional·Posted Dec 14, 2018·Updated Oct 9, 2024

In Brief

A Phase 2 clinical trial evaluating lenvatinib and pembrolizumab for Advanced Melanoma. Completed, enrolled 103 participants across 23 sites in 5 countries.

Detailed Summary

This study will evaluate the safety and efficacy of combination therapy of lenvatinib (E7080/MK-7902) and pembrolizumab following approximately 2 years of pembrolizumab therapy and approximately 2 years or more lenvatinib therapy in adult participants with unresectable or advanced melanoma who have been exposed to anti-programmed cell death ligand 1 (PD-1/L1) agents approved for unresectable or metastatic melanoma. No statistical hypothesis will be tested in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Melanoma
CountriesAustralia, Canada, Spain, Sweden, United States
CollaboratorsEisai Inc.

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 14, 2018
Enrollment StartJan 30, 2019
Primary CompletionOct 11, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 7.5 years ago

Interventions

lenvatinibdrug

Administered orally once a day during each 21-day cycle.

pembrolizumabbiological

Administered as an IV infusion on Day 1 Q3W.