A Phase II Study of Nemvaleukin Alfa in People with Cutaneous Melanoma or Mucosal Melanoma

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Full Title

A Phase 2, Open-label, Multicenter, Cohort Study of Nemvaleukin Alfa (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

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational immunotherapy drug nemvaleukin alfa in people with inoperable or metastatic cutaneous (skin) melanoma or mucosal melanoma (melanoma that begins in the mucus membranes that line various parts of the body). Nemvaleukin alfa works by attaching to an immune system protein called interleukin 2 and triggering an increase in the number of immune cells. By helping to increase immune cells, nemvaleukin alfa may boost the body’s natural defenses against cancer.

Participants with cutaneous melanoma will receive nemvaleukin alfa as a subcutaneous (under the skin) injection, and those with mucosal melanoma will receive this treatment intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic cutaneous or mucosal melanoma that has continued to grow despite prior immunotherapy that targeted the PD-L1 protein (such as nivolumab and pembrolizumab).
  • At least 4 weeks must pass between the completion of prior treatments and receipt of nemvaleukin alfa.
  • Only two prior regimens of intravenous or pill-based treatments for melanoma are allowed.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Alexander Shoushtari at 646-888-4161.

Protocol

22-151

Phase

II

Co-Investigators

Diseases