Study on IO102/IO103, Nivolumab, and Relatlimab for People with Melanoma

Inclusion Criteria

• Must be 18 years or older.
• Able to provide informed consent.
• Have a confirmed diagnosis of advanced melanoma that cannot be surgically removed or has spread.
• Have not received any prior treatment for advanced melanoma, except for certain treatments given more than 6 months before the cancer returned.
• Have at least one measurable melanoma lesion outside of bones and the brain.
• 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 adequate blood and organ function based on specific lab tests.
• Women of childbearing potential must use two effective birth control methods during the study and for 23 weeks after the last dose.
• Men must use effective birth control methods during the study and for at least four months after the last dose and agree not to donate sperm during this time.

Exclusion Criteria

• Have uveal melanoma.
• Have untreated brain metastases or cancer spread to the brain lining, unless treated and stable.
• Have received immunotherapy for advanced melanoma or other cancers, except for certain treatments given more than 6 months before the cancer returned.
• Are on high-dose steroid therapy or other immunosuppressive medications within 14 days of starting the study.
• Have received a live vaccine within 30 days of starting the study.
• Have a history of certain autoimmune nerve disorders.
• Have another active cancer requiring treatment or affecting melanoma assessment.
• Have severe allergies to unknown substances or study drugs.
• Have uncontrolled medical conditions that could affect safety or study compliance.
• Have active hepatitis B or C with high viral loads.
• Are pregnant or breastfeeding.
• Are prisoners or involuntarily incarcerated, unless local regulations allow participation.
• Are detained for psychiatric or physical illness treatment.