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)
Eikon Therapeutics
Summary
The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: To be eligible for inclusion in this study, participants must: * Be ≥ 18 years of age on the day of signing of informed consent. * Have a life expectancy of at least 3 months. * Have histologically or cytologically confirmed Stage 3 (unresectable) or Stage 4 metastatic melanoma per AJCC 8th ed. and be eligible for standard therapy with pembrolizumab. * Have at least 1 lesion with measurable disease at Baseline by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by assessment of local site Investigator/radiologist. * Have known BRAF V600 mut…
Interventions
- DrugEIK1001
EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
- DrugPembrolizumab (KEYTRUDA® )
Pembrolizumab is a PD-1 inhibitor.
Locations (107)
- Ironwood Cancer & Research CentersChandler, Arizona
- Genesis Cancer and Blood InstituteHot Springs, Arkansas
- Helios Clinical ResearchLos Angeles, California
- Providence Medical FoundationSanta Rosa, California
- UCHealth Memorial Hospital CentralColorado Springs, Colorado
- Bioresearch PartnerHialeah, Florida