๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-09

Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma (NCT07631325)

A Phase II Trial of MOR Antagonism With Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma (MORALE-MM)

๐ŸŸก Not Yet Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: John Kirkwood

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: UPMC Hillman Cancer Center โ€” Pittsburgh, Pennsylvania

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • UPMC Hillman Cancer Center โ€” Pittsburgh, Pennsylvania

๐Ÿ“ž Contact the Study Coordinator

Phone: (412) 623-1191

Email: bednarzdl@upmc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—