Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)

Summary

The purpose of this 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 adults with no prior systemic therapy for their advanced melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Timeline

Start

2019-03-12

Primary completion

2023-01-18

Completion

2024-11-01

Publications

• Results Arance A, Berciano-Guerrero MA, Guo J, Carlino MS, Ascierto PA, Burotto M, Mortier L, Queirolo P, Chiarion-Sileni V, Schachter J, Zhang X, Martin-Liberal J, Del Vecchio M, Okpara CE, Dutcus C, Zhang J, Diede SJ, Neff T, Long GV. Randomized, double-blind, phase III LEAP-003 study of first-line lenvatinib plus pembrolizumab versus placebo plus pembrolizumab for unresectable or metastatic melanoma. Ann Oncol. 2025 Dec;36(12):1535-1546. doi: 10.1016/j.annonc.2025.08.008. Epub 2025 Aug 28.

Drugs

Indications