NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB-IV (M1a) Melanoma

Inclusion criteria

• Written informed consent will be obtained to participate in the study, and HIPAA authorization for the release of personal health information.
• Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee, including randomization.
• Age ≥ 18 years at the time of consent.
• ECOG Performance Status of 0-2.
• Histological confirmation of cutaneous melanoma or melanoma of unknown primary.
• AJCC stage IIIB/IVa resectable disease that is measurable by iRECIST criteria.
• Adequate hematologic, renal, hepatic, and heart function

Exclusion criteria

• Prior treatment with PD-1 Programmed cell death Protein 1 (PD-1) and Cytotoxic T-lymphocyte Antigen 4 (CTLA-4).
• Has an active autoimmune disease that requires systemic treatment with the use of disease-modifying agents or immunosuppressive drugs. For corticosteroids, up to 10 mg of prednisone daily, or an equivalent dose, is permitted. Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Any condition, including laboratory abnormalities, that, in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illnesses that are likely to interfere with participation in this clinical study.