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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
John Kirkwood
Study ID
NCT07631325
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Unresectable Cutaneous Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axelopran — DRUG
    A peripherally restricted mu-opioid receptor antagonist (PAMORA) designed to mitigate the undesirable peripheral effects of opioids without compromising their central analgesic action.
  • Nivolumab — DRUG
    An immune checkpoint inhibitor that helps the immune system attack cancer cells by blocking PD-1 receptors.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2030

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Axelopran + Nivolumab
    Run in (1 week): Days -6 to -4: 5 mg PO daily Days -3 to 0: 15 mg PO daily Combination Phase: Axelopran: 15 mg PO daily Nivolumab: 480 mg IV q4w (until disease progression, up to 3 years)

Primary Outcome Measure

Adverse Events Related to Treatment [ Time Frame: Up to 30 days post end of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIP
UPMC Hillman Cancer CenterPittsburghPennsylvania15232

Find similar trials in Pittsburgh, PA

By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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