Phase 3 Study of Epacadostat and Pembrolizumab in Melanoma
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects with Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
IRAS ID
200941
Contact name
James Larkin
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2015-004991-31
Duration of Study in the UK
4 years, months, days
Research summary
Melanoma is a serious type of skin cancer that strikes in adults, more frequent in men than women and is the 5th most common cancer in the UK.
Standard treatment such as surgical excision is unlikely to cure unresectable (cannot be surgically removed) and metastatic melanoma due to some of the cancer cells being too small to be detected. High-dose interleukin-2 can cure a small proportion of patients but severe side effects limits its use.
Despite recent advances in treatment with immunotherapies such as ipilimumab and pembrolizumab, not all patients respond to the current therapies. There is a need for new treatment options or to investigate combination therapies which can potentially be more effective than treatment with a single medication.
Pembrolizumab and epacadostat are both immunotherapies that target different parts of the immune system. Early data suggests that the combination of these two drugs may lead to an enhanced antitumour immune response compared to either drug alone.
This is a research study to test the combination of two drugs, pembrolizumab and epacadostat in patients with unresectable and metastatic melanoma.
Approximately 600 patients will be enrolled in this double blinded phase III study which will last about 3 years. Patients will receive either pembrolizumab and epacadostat or pembrolizumab and placebo. Patients will have a I in 2 chance of being assigned to either treatment group.Patients will receive pembrolizumab as an intravenous infusion at 200 mg every 3 weeks and either epacadostat at a dose of 100mg or placebo which is taken by mouth daily in the morning and evening until disease progression, intolerable toxicity, or withdrawal of consent.
The study is sponsored by Incyte Corp. and study execution is being conducted by Merck Sharp & Dohme Limited. ("MSD") and will take place at 4 sites in the UK.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0648
Date of REC Opinion
27 May 2016
REC opinion
Further Information Favourable Opinion