Pembro + Lenvatinib as First-line Intervention for Advanced Melanoma
Research type
Research Study
Full title
A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants with Advanced Melanoma (LEAP-003)
IRAS ID
256361
Contact name
Mark Harries
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2018-002520-16
Duration of Study in the UK
5 years, 2 months, 0 days
Research summary
Melanoma is the most serious form of skin cancer and affects adults of all ages. The 5-year prevalence of melanoma in the European Union is approximately 326,000 patients with an incidence of approximately 83,000 per year and approximately 16,000 deaths annually.
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells meet cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. The activated immune cells become exhausted or die thus stopping them from attacking the cancer. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
Pembrolizumab is approved by the Food and Drug Administration and the European Commission for the treatment of both first-line and previously treated patients with advanced melanoma. However, there is a large population (~60%) of patients who do not respond to therapy with anti-PD-1 agents. As such, combination strategies as first-line treatment are needed.
Lenvatinib works by blocking proteins called Vascular Endothelial Growth Factors which cancer cells can use to help themselves grow and develop new blood vessels. Early studies have shown promising efficacy with the combination of lenvatinib and pembrolizumab in participants with melanoma.
This phase 3 study will last approximately 61 months and will recruit approximately 660 participants aged 18+ with advanced melanoma. The purpose of the study is to evaluate the effectiveness and safety of pembrolizumab in combination with lenvatinib, versus pembrolizumab with placebo. Participants will be assigned randomly in 1:1 ratio to one of the two treatment arms.
The study is sponsored by Merck Sharp & Dohme Limited (MSD), and co-funded by MSD and Eisai. It will take place at 4 study centres in UK.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0404
Date of REC Opinion
11 Feb 2019
REC opinion
Further Information Favourable Opinion