NCT06697301

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

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 (TeLuRide-006)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 740 (estimated)
• Sponsor: Eikon Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.

Detailed description

This is 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. The study includes dose optimization and expansion parts.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	EIK1001	EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
DRUG	Pembrolizumab (KEYTRUDA® )	Pembrolizumab is a PD-1 inhibitor.

Timeline

• Start date: 2025-05-22
• Primary completion: 2035-12-01
• Completion: 2040-12-01
• First posted: 2024-11-20
• Last updated: 2025-11-12

Locations

77 sites across 22 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Israel, Italy, New Zealand, Norway, Poland, Portugal, Serbia, South Africa, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study