Evaluating the Safety and Efficacy of EIK1001 and Pembrolizumab in advanced Melanoma patients
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants with Advanced Melanoma
IRAS ID
1010586
Contact name
Bensheng Liu
Contact email
Sponsor organisation
Eikon Therapeutics
Eudract number
2024-512659-19
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Melanoma is the fifth most common cancer in the UK, accounting for around 4% of all new cancers. For participants with advanced Melanoma, the 5 year survival rate is approximately 35%. Melanoma has been resistant to current treatments available, and there is a critical need to develop more effective treatments. EIK1001 is a medication in development for the treatment of advanced solid tumours, such as melanoma. EIK1001 operates on the immune responsiveness of melanoma, and has been shown to enhance mechanisms of the immune system to treat cancer cells.
The aim of this study is to develop a novel combination therapy, which involves the administration of EIK1001 + Pembrolizumab. This study will evaluate the Safety and efficacy of EIK1001 and Pembrolizumab, versus Placebo and Pembrolizumab in participants with Advanced Melanoma.
This study is aimed at participants aged 18+ with unresectable Stage 3 or Stage 4 (advanced) Melanoma, who must have not received prior systemic therapy for advanced Melanoma. The study will require approximately 10 years involvement from the participant, and the treatment duration will be up to two years. The visit frequency will be once weekly until 27 weeks. The visit frequency will then be reduced to once every 3 weeks. Approximately 740 participants will be enrolled in this study.
Participants will undergo: Screening; Treatment; an Active Follow-up Period, consisting of an End of Treatment visit, a Safety Follow-up visit; and Survival follow-up contact. For the treatment stage, participants will be administered with EIK1001 or placebo over 30 minutes by IV infusion; followed by a 60 minute pause; and pembrolizumab will be administered over 30 minutes by IV infusion.REC name
South Central - Oxford C Research Ethics Committee
REC reference
24/SC/0350
Date of REC Opinion
21 Nov 2024
REC opinion
Further Information Favourable Opinion