Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma - ARTISTRY-6

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study observes the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.

Criteria

Inclusion Criteria:

• The patient must have advanced cutaneous melanoma or acral melanoma; no more than 5 patients with acral melanoma may enroll in this cohort (Cohort 1). Or, the patient must have unresectable and/or metastatic mucosal melanoma (Cohort 2).

• Patient must have received previous treatment as follows: a) patient has received anti-PD-[L]1 therapy ± anti-CTLA-4 therapy, and ≤1 other prior regimen of systemic anti-neoplastic therapy; b) patient should have experienced objective response (PR or CR) or SD as BOR to anti-PD-[L]1 therapy; c) patients with BRAF mutations may or may not have received prior targeted therapy.

• Patients must have disease that is measurable based on RECIST 1.1., that has not recently been irradiated or used to collect a biopsy.

• Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying archival tumor tissue.

• Patient has an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 and an estimated life expectancy of ≥3 months.

• Additional criteria may apply.

Exclusion Criteria:

• Patient has uveal melanoma.

• Patient has received prior IL-2-based or IL-15-based cytokine therapy.

• Patient requires systemic corticosteroids (>10 mg of prednisone daily, or equivalent) however, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.

• Patient has undergone prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant.

• Patient is currently pregnant, breastfeeding, or is planning to become pregnant or to begin breastfeeding during the study period or within 30 days after last study drug administration.

• Patients with active or symptomatic central nervous system metastases unless the metastases have been treated by surgery and/or radiation therapy and/or gamma knife, the subject has been tapered to a dose of 10 mg of prednisone (or equivalent) or less of corticosteroids for at least 2 weeks before the first dose, and the subject is neurologically stable. Patients with leptomeningeal disease are excluded.

• Patient has known or suspected hypersensitivity to any components of nemvaleukin.

• Patients with an uncontrollable bleeding disorder.

• Patient has QT interval corrected by the Fridericia Correction Formula values of >470 msec (in females) or >450 msec (in males); patient who is known to have congenital prolonged QT syndromes; or patient who is on medications known to cause prolonged QT interval on ECG.

• Patient has developed Grade ≥3 immune-related AEs (irAEs) while on prior immunotherapy, (eg, pneumonitis, nephritis, and neuropathy).

• Additional criteria may apply.