NCT03776136

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	lenvatinib	Administered orally once a day during each 21-day cycle.
BIOLOGICAL	pembrolizumab	Administered as an IV infusion on Day 1 Q3W.

Timeline

• Start date: 2019-01-30
• Primary completion: 2023-10-11
• Completion: 2023-10-11
• First posted: 2018-12-14
• Last updated: 2024-10-09
• Results posted: 2024-10-09

Locations

23 sites across 5 countries: United States, Australia, Canada, Spain, Sweden

Regulatory

• FDA-regulated drug study