Treatment of Advanced Melanoma With MK-3475 and Peginterferon

This is a safety and dose-seeking study of combination MK-3475 and peginterferon alfa-2b for adult patients (≥18) with advanced melanoma. A total of 32 patients will be included. Subjects will undergo screening evaluations to determine eligibility within 28 days (4 weeks) of the first dose. Each 21 day dosing period will constitute a cycle. Peginterferon alfa-2b is given subcutaneously, weekly according to the regimen below. peginterferon alfa-2b (Sylatron) is FDA-approved for the adjuvant treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. MK-3475 is a potent humanized IgG4 mAb with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2. MK-3475 has an acceptable preclinical safety profile and is being advanced for clinical development as an immunotherapy for advanced malignancies. In this protocol, MK-3475 is being evaluated at 2 mg/kg intravenously every 3 weeks for 2 years in combination with peginterferon alfa-2b at 1 µg/kg/week, 2 µg/kg/week, or 3 µg/kg/week by subcutaneous injection.