Axelopran added to pembrolizumab for frontline recurrent/metastatic head and neck cancer
Official title: A Phase 2 Trial of Axelopran Plus Pembrolizumab for the First-Line Treatment of Recurrent/Metastatic HNSCC That Is PD-L1 Positive (PD-L1CPS >1)
Funded at Glycyx Mor, INC. · NIH-11418514 · Data updated 2026-11-12
A new treatment approach combines axelopran with pembrolizumab for people with PD-L1 positive recurrent/metastatic head and neck cancer to see if it improves response.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Glycyx Mor, INC. NIH-funded |
| Lab location | 1 site (San Francisco, United States) |
| Project start | September 19, 2025 |
| Project end | August 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $1,047,803 |
| NIH project number | 5R44CA306565-02 |
| Project ID | NIH-11418514 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive (CPS ≥ 1) and currently using opioid analgesics for cancer-related pain.
✕Less likely to help
Patients whose tumors do not respond to pembrolizumab or who cannot tolerate axelopran may not benefit.
What this research studies
This project tests whether adding axelopran, a non-brain-acting opioid blocker, to standard pembrolizumab helps people with recurrent or metastatic head and neck cancer who are taking opioid pain medicines. The study will compare responses to historical data to see if more tumors shrink or disappear. It focuses on patients whose tumors express PD-L1 and who need pain relief, aiming to balance pain control with potentially better cancer control. If successful, this could pave the way for a new combination approach in this cancer and possibly other solid tumors.
Why it matters
Potential benefit: If successful, patients may experience higher tumor shrinkage rates and potentially longer control of the cancer when using this combination.
How similar studies have gone: This is an early phase trial building on preclinical data suggesting opioid interactions with immune therapy; human data are limited.
Where this research is happening
-
Glycyx Mor, INC.
San Francisco, United States Active
Researchers
- Principal investigator: Johnson, Lorin K — Glycyx Mor, INC.
- Study coordinator: Johnson, Lorin K
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.