drugset / Trial / NCT07631325

Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma

NCT07631325

Phase 1/2 Not yet recruiting 28 enrolled John Kirkwood Glycyx MOR Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-10-31
Primary completion
2028-07-31
Completion
2030-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Subject axelopran Small molecule 15 mg Oral

Indications