A multicenter, randomized, double-blind, comparator-controlled, Phase II/III study to assess the safety and efficacy of EIK1001 and Pembrolizumab compared to placebo and Pembrolizumab as first-line therapy in participants with advanced melanoma

Melanoma is the sixth most common cancer in Switzerland, accounting for about 4.1% of all new cancer cases. In participants with advanced melanoma, the 5-year survival rate is approximately 40%. Melanoma is resistant to currently available treatments, and there is an urgent need to develop more effective therapies. EIK1001 is a drug in development for the treatment of melanomas and has been shown to enhance the immune system's mechanisms to fight cancer cells. The aim of this study is to develop a novel combination therapy in which EIK1001 + Pembrolizumab will be administered to participants with advanced melanoma. This study targets participants aged 18 years and older with inoperable melanoma at stage 3 and stage 4 (advanced), who must not have received prior systemic therapy for advanced melanoma. The study requires participant involvement for approximately 10 years, with a treatment duration of up to two years. The frequency of visits until week 27 is once a week. The frequency then decreases to once every 3 weeks. Approximately 740 participants will be enrolled in this study. Participants will go through the following sections: pre-screening; treatment; an active follow-up period consisting of a visit at the end of treatment, a visit for safety follow-up, and a contact for survival follow-up. In the treatment section, participants will receive EIK1001 or a placebo as an intravenous (i.v.) infusion for 30 minutes, followed by a 60-minute break. Pembrolizumab will be administered over 30 minutes as an i.v. infusion.

Patients with previously untreated advanced melanoma

Advanced melanoma