Evaluating Safety and Effectiveness of EIK1001 with Pembrolizumab Compared to Placebo with Pembrolizumab as First Treatment for Advanced Melanoma

What this Trial Is About

This research aims to evaluate the safety and effectiveness of EIK1001 combined with Pembrolizumab compared to placebo plus Pembrolizumab as a first treatment in patients with advanced melanoma. The study is a multicenter, randomized, double-blind, active comparator-controlled, adaptive Phase 23 trial including dose optimization and expansion parts. Participants must have advanced melanoma eligible for standard pembrolizumab therapy. Participants are assigned randomly to one of three groups placebo with Pembrolizumab, EIK1001 at dose 1 plus Pembrolizumab, or EIK1001 at dose 2 plus Pembrolizumab. EIK1001 is a dual agonist targeting Toll-like receptor 78, and Pembrolizumab is a PD-1 inhibitor. The study includes dose optimization and expansion phases to assess the treatments as first-line therapies. During the trial, participants will undergo regular assessments including imaging by CT or MRI to measure tumor response using RECIST 1.1 criteria. Safety is monitored through reports of adverse events and laboratory tests. The primary outcomes include progression-free survival and overall survival monitored up to 5 years, with additional evaluation of response duration and adverse events. Participation involves ongoing treatment and follow-up visits throughout the study period.

Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.