A Phase 2 Open-label Multicenter Cohort Study of ALKS 4230 Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]1 Therapy - ARTISTRY-6

Brief description of study

The purpose of the study is to evaluate the antitumor activity, safety and tolerability 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. ALKS 4230 is a novel immunotherapeutic protein being developed by Alkermes, Inc. (Alkermes) as an intravenous (IV) and subcutaneous (SC) therapy for the treatment of patients with advanced, refractory solid tumors. The study drug ALKS 4230 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-01300
ClinicalTrials.gov Identifier: NCT04830124
Principal Investigator: Jeffrey S. Weber.
Other Investigators: Nila Theresa De La Rosa, Maya Dimitrova, Kathleen M Madden, Janice Mehnert.


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