Study on the Safety and Effectiveness of EIK1001 with Pembrolizumab Compared to Placebo and Pembrolizumab for First-Line Treatment in Advanced Melanoma

Inclusion Criteria

• Must be 18 years or older.
• Have a life expectancy of at least 3 months.
• Have confirmed advanced melanoma (Stage 3 or 4) that cannot be removed by surgery and be eligible for standard treatment with Pembrolizumab.
• Have at least one tumor that can be measured by scans.
• Know the status of a specific gene mutation (BRAF V600) or agree to testing for it.
• Have completed any prior radiation therapy at least 2 weeks before starting the study treatment.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have normal blood and organ function based on recent tests.
• Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective birth control during the study and for 120 days after the last dose.
• Men must agree to use effective birth control during the study and for 120 days after the last dose if their partner is a woman of childbearing potential.
• Be willing to provide written informed consent to participate in the study.

Exclusion Criteria

• Have melanoma that started in the eye.
• Are currently in another clinical trial or have recently been in one and received an investigational drug.
• Have received systemic treatment for advanced melanoma before the first dose of the study drug.
• Have had severe side effects from previous anti-PD-1 therapy.
• Have had major surgery less than 3 weeks before starting the study.
• Have received a live vaccine within 30 days before starting the study.
• Have a history of another cancer unless it was treated and has not returned for 5 years.
• Have active cancer spread to the brain or spinal cord unless treated and stable.
• Have a heart condition with a specific abnormal heart rhythm.
• Have an active autoimmune disease requiring treatment in the past 2 years, except for certain conditions like Type 1 diabetes or hypothyroidism.
• Are on chronic steroid or immunosuppressive treatment.
• Have a history of lung disease requiring steroids.
• Have active infections needing treatment.
• Have uncontrolled HIV infection.
• Have active hepatitis B or C infection.
• Have any condition that might interfere with the study results or participation.
• Have a psychiatric or substance abuse disorder that would interfere with study participation.
• Are pregnant, breastfeeding, or planning to have children during the study.
• Are taking medications that strongly affect certain liver enzymes.