Perlmutter Cancer Center

This is a Phase 2, global, multicenter, open-label, cohort study designed to evaluate the antitumor activity, safety and tolerability, HRQoL, PK, and pharmacodynamics of ALKS 4230 given as monotherapy in patients with unresectable and/or metastatic melanoma following prior anti-PD-[L]1 therapy with or without anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) therapy. Patients will be enrolled into one of the following cohorts based on the patient’s specific tumor type: ? Advanced cutaneous melanoma (Cohort 1) ? Advanced mucosal melanoma (Cohort 2) Cohort 1: Patients in the advanced cutaneous melanoma cohort will receive treatment at the recommended Phase 2 dose (RP2D) and dosing schedule (either every 7 or 21 days [q7d or q21d]) of subcutaneous (SC) ALKS 4230 as identified in the Phase 1/2 ARTISTRY-2 study (ALKS 4230-001). Cohort 2: Patients in the advanced mucosal melanoma cohort will receive intravenous (IV) ALKS 4230 at the RP2D and dosing schedule as identified in the Phase 1/2 ARTISTRY-1 study (ALK4230-A101) as follows: ? Cycle 1: 6 µg/kg/day for 5 consecutive days followed by 9 days off treatment, for a total of 14 days for the treatment cycle ? Cycle 2 and all subsequent cycles: 6 µg/kg/day for 5 consecutive days followed by 16 days off treatment, for a total of 21 days each treatment cycle. Across both cohorts, patients should continue receiving ALKS 4230 for as long as they are experiencing disease control and/or immune disease control and are tolerating treatment well, or until any other criteria for treatment discontinuation are met.