Axelopran in Patients With Anti-PD-1 Refractory Metastatic or Locoregionally Unresectable Cutaneous 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.

NCT Number	NCT07631325
Lead Sponsor	John Kirkwood Collaborators: Glycyx MOR Inc.
Conditions	Unresectable Cutaneous Melanoma
Enrollment	28 participants
Start Date	2026-07-31
Primary Completion	2028-07-31 (estimated)
Study Completion	2030-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-08