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

Official Title

A Phase 2, Open-label, Multicentre, 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

Summary:

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

Trial Description

Primary Outcome:

  • Centrally-assessed overall response rate (ORR)
Secondary Outcome:
  • Centrally-assessed duration of response (DOR)
  • Centrally-assessed progression free survival (PFS)
  • Centrally-assessed disease control rate (DCR)
  • Centrally-assessed time to response (TTR)
  • Incidence of treatment-emergent adverse events
  • Investigator-assessed overall response rate (ORR)
  • Investigator-assessed duration of response (DOR)
  • Investigator-assessed progression free survival (PFS)
  • Investigator-assessed disease control rate (DCR)
  • Investigator-assessed time to response (TTR)
  • Investigator-assessed immune overall response rate (iORR)
  • Investigator-assessed immune duration of response (iDOR)
  • Investigator-assessed immune progression free survival (iPFS)
  • Investigator-assessed immune disease control rate (iDCR)
  • Investigator-assessed immune time to response (iTTR)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society