Study on Fianlimab, Cemiplimab, and Ipilimumab for Treating Melanoma

Inclusion Criteria

• Must be 18 years or older.
• Must be able to provide informed consent.
• Must have a confirmed diagnosis of advanced melanoma that cannot be removed by surgery or has spread, and has worsened after previous PD-1/PD-L1 therapy.
  • For Cohort A: Melanoma must have worsened after PD-1 monotherapy.
  • For Cohort B: Melanoma must have worsened after PD-1 and LAG-3 therapy.
• Must have measurable disease as defined by specific medical criteria.
• Must be willing to provide a tissue sample for research if available.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have adequate blood and organ function as determined by specific tests.
• Must not have signs of active heart problems.
• Must have a creatinine clearance of at least 30 mL/min.
• Any side effects from previous immune therapy must have improved to a mild level.
• Women of childbearing potential and sexually active men must use effective contraception during the study and for at least 6 months after the last dose.
• Men must use condoms unless they are sterile or abstain from sex.

Exclusion Criteria

• Have uveal melanoma.
• Have untreated brain or spinal cord cancer spread.
• Have received certain prior therapies, depending on the cohort.
• Have had severe nerve-related side effects from previous immune therapy.
• Have had heart inflammation from previous immune therapy.
• Are taking high-dose steroids or other immune-suppressing medications.
• Have received a live vaccine within 30 days before starting the study.
• Have a significant infection requiring antibiotics within 2 weeks before starting the study.
• Have uncontrolled medical conditions that could affect safety or compliance.
• Have another active cancer requiring treatment.
• Have severe allergies to study drugs.
• Have uncontrolled HIV, hepatitis B, or hepatitis C infections.
• Are pregnant or breastfeeding.
• Are prisoners or involuntarily incarcerated.
• Are detained for psychiatric or physical illness treatment.