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Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma

NCT07631325 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-07-13

No results posted yet for this study

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.

Conditions

  • Unresectable Cutaneous Melanoma

Interventions

DRUG

Axelopran

A peripherally restricted mu-opioid receptor antagonist (PAMORA) designed to mitigate the undesirable peripheral effects of opioids without compromising their central analgesic action.

DRUG

Nivolumab

An immune checkpoint inhibitor that helps the immune system attack cancer cells by blocking PD-1 receptors.

Sponsors & Collaborators

  • Glycyx MOR Inc.

    collaborator INDUSTRY

  • John Kirkwood

    lead OTHER

Principal Investigators

  • John M Kirkwood, MD · UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2028-07-31
Completion
2030-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07631325 on ClinicalTrials.gov