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Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma

Study acronym: MORALE-MM
StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Start date: Jul 31, 2026 to Oct 31, 2026
    • Study description shortened, about 8 words
    • Study title shortened, about 5 words
    v3
  2. Minor Study description expanded, about 33 wordsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,092 trials monitored
See 60 trials at risk
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.
Trial Details
NCT Number NCT07631325
Lead Sponsor John Kirkwood
Collaborators: Glycyx MOR Inc.
Conditions
(from sponsor)
Unresectable Cutaneous Melanoma
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov