Study on Nemvaleukin Alfa Alone and with Pembrolizumab for Advanced Skin or Mucosal Melanoma - ARTISTRY-6

Sponsor: Mural Oncology, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04830124

Provider View

This clinical trial is exploring the effects of Nemvaleukin Alfa, both alone and in combination with Pembrolizumab, on patients with advanced melanoma that cannot be surgically removed or has spread to other parts of the body. The study focuses on the treatment's ability to fight tumors, its safety, and how well patients tolerate it.

Patient Parameters

Program Overview

The purpose of this study is to observe how well Nemvaleukin Alfa, alone or with Pembrolizumab, works in treating advanced melanoma that cannot be removed by surgery or has spread. Researchers are looking at how the treatment affects tumors, its safety, and how patients respond to it.

Eligibility Criteria

Inclusion Criteria

  • Have advanced melanoma that cannot be surgically removed or has spread, fitting into one of the following groups:
    • Group 1: Skin melanoma, with a limit of 5 patients having acral melanoma.
    • Group 2: Mucosal melanoma.
    • Group 3: Skin melanoma, excluding acral melanoma.
    • Group 4: Skin melanoma, excluding mucosal or acral melanoma.
  • Have received previous treatments as follows:
    • Groups 1 and 2: Must have had anti-PD-1 therapy, possibly with anti-CTLA-4 therapy, and no more than one other systemic treatment. Must have shown some response or stable disease to anti-PD-1 therapy.
    • Group 3: Must have had anti-PD-1 therapy, possibly with anti-CTLA-4 or anti-LAG-3 therapy, and no more than one other systemic treatment. Must have shown some response or stable disease to anti-PD-1 therapy.
    • Group 4: Must not have had prior systemic treatment for advanced melanoma, except for certain previous treatments if there was a 6-month gap before recurrence.
  • Have measurable disease that has not been recently treated with radiation or used for biopsy.
  • Be willing to undergo a tumor biopsy or provide a previous tumor sample.
  • Have a specific health status score (ECOG 0 or 1) and an expected life expectancy of at least 3 months.
  • Additional criteria may apply.

Exclusion Criteria

  • Have uveal melanoma or acral melanoma (for certain groups).
  • Have had previous treatments with certain cytokine therapies or interleukin-based therapies.
  • Require high doses of systemic steroids, except for certain types like topical or inhaled steroids.
  • Have had a solid organ or non-autologous stem cell transplant.
  • Are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study or shortly after.
  • Have active or untreated brain metastases unless treated and stable.
  • Have allergies to study drugs.
  • Have uncontrollable bleeding disorders.
  • Have certain heart conditions or are on medications affecting heart rhythm.
  • Have severe immune-related side effects from previous immunotherapy that have not improved.
  • Have discontinued previous immunotherapy due to immune-related side effects.
  • For Group 4: Have a history of lung inflammation requiring steroids or current lung inflammation.
  • Additional criteria may apply.

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