Study on Immunotherapy Before and After Surgery for Advanced Melanoma

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of melanoma at specific stages.
• No prior systemic therapy for melanoma for Part 1 and Part 2 Cohort A.
• For Part 2 Cohort B, melanoma must be advanced and not responding to previous treatments.
• Must be considered operable by a surgeon.
• Must have adequate organ function and be in good overall health.
• Must provide a recent tumor sample for analysis.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 5 months after the last treatment.
• Men must agree to use effective contraception if their partner is of childbearing potential.
• Must be willing to follow study procedures and provide informed consent.

Exclusion Criteria

• Pregnant or breastfeeding women.
• Recent treatment with another investigational drug or systemic therapy for melanoma.
• Recent major surgery or significant infection.
• History of certain types of melanoma or bowel obstruction.
• Significant heart disease or recent stroke.
• Active or history of brain metastases.
• Other active cancers requiring treatment.
• Recent treatment with certain drugs or vaccines.
• Known allergies to study drugs.
• History of lung disease or organ transplant.
• Active autoimmune disease or recent use of immunosuppressive drugs.
• Recent COVID-19 infection.
• Uncontrolled HIV or hepatitis infections.
• Dependence on total parenteral nutrition.
• Certain heart conditions or history of myocarditis.
• Must not have a history of allergy to study components.