Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma

This first-in-human study will evaluate the safety, clinical activity, and immunologic effects of combining axelopran with nivolumab in patients with PD-1-refractory unresectable or metastatic cutaneous melanoma. Exploratory analyses incorporating opioid exposure history and post-hoc OPRM1 genotyping will inform future precision immuno-oncology strategies.

Trial Details

NCT ID
NCT07631325
Phase
PHASE1 / PHASE2
Sponsor
John Kirkwood
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Axelopran
  • Nivolumab
Locations (sample)
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589

Key Eligibility Criteria

  • Histologically confirmed, unresectable or metastatic cutaneous melanoma with documented PD-1-refractory disease, defined as disease progression dur…
  • Primary resistance: Disease progression as best response, or stable disease lasting \<6 months, following at least 6 weeks (approximately two cycle…
  • Secondary (acquired) resistance: Disease progression occurring after an initial objective response (complete or partial response) or durable stable…
  • Note: Disease must have been histologically confirmed through prior pathology assessment conducted as per SOC.

For full eligibility, visit ClinicalTrials.gov.

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