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
Outcome
Mixed primary results
registry analysis (superiority test); Pembrolizumab+Lenvatinib vs Pembrolizumab+Placebo; p = 0.0176; Hazard Ratio (HR) 0.81 (95% CI 0.67 to 0.98); Log Rank NCT03820986 ↗
registry analysis (superiority test); Pembrolizumab+Lenvatinib vs Pembrolizumab+Placebo; p = 0.9521; Hazard Ratio (HR) 1.20 (95% CI 0.97 to 1.48); Log Rank NCT03820986 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 20 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |