drugset / Trial / NCT07631325
Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-10-31
- Primary completion
- 2028-07-31
- Completion
- 2030-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | axelopran | Small molecule | 15 mg | Oral |