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

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.

Timeline

Start

2020-07-14

Primary completion

2023-01-18

Completion

2024-11-01

Outcome

Mixed primary results

registry Pembrolizumab+Lenvatinib vs Pembrolizumab+Placebo; p = 0.0013; Hazard Ratio (HR) 0.55 NCT04889118 ↗

registry Pembrolizumab+Lenvatinib vs Pembrolizumab+Placebo; p = 0.3728; Hazard Ratio (HR) 0.93 NCT04889118 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenvatinib	Small molecule	20 mg	Oral
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Indications