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NCT07631325 · ClinicalTrials.gov registry record · Phase 1
Axelopran in Patients With Anti-PD-1 Refractory Metastatic or Locoregionally Unresectable Cutaneous Melanoma
A Phase 1 study, sponsored by John Kirkwood.
- Not yet
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT07631325: Clinical Trial Phase 1 study, sponsored by John Kirkwood.
NCT07631325 is a Phase 1 study that has not yet begun recruiting, run by John Kirkwood. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07631325, a Phase 1 study, has not yet begun recruiting, sponsored by John Kirkwood.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
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.
Primary Outcome
Adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation or death, and severity of AEs as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) determined to be possibly, probably or definitely related to study treatment.
Interventions
- DRUG Nivolumab
- DRUG Axelopran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2026-07-31 |
| Est. Completion | 2030-07-31 |
| Phase | Phase 1 |
What is known before NCT07631325 opens enrollment
NCT07631325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT07631325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07631325 about?
NCT07631325 is a clinical study titled "Axelopran in Patients With Anti-PD-1 Refractory Metastatic or Locoregionally Unresectable Cutaneous Melanoma". 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 genotypin...
What is the current status of trial NCT07631325?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2026-07-31. Estimated completion is 2030-07-31.
What interventions are being tested in trial NCT07631325?
The interventions under investigation include: Nivolumab (DRUG), Axelopran (DRUG).
Who is sponsoring clinical trial NCT07631325?
This trial is sponsored by John Kirkwood, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07631325's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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