PEP-CMV vaccine with nivolumab for pediatric and adult high-grade brain tumors
Official title: Phase 1/2 trial of PEP-CMV + nivolumab for newly diagnosed diffuse midline glioma/high-grade glioma and recurrent diffuse midline glioma/high-grade glioma, medulloblastoma, and ependymoma (PRiME II)
Funded at Washington University · NIH-11312693 · Data updated 2026-11-12
A phase 1/2 trial tests a CMV-targeted vaccine plus a PD-1 blocker for newly diagnosed and recurrent high-grade brain tumors in children and adults.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Washington University NIH-funded |
| Lab location | 1 site (Saint Louis, United States) |
| Project start | April 4, 2025 |
| Project end | March 31, 2030 |
| Funding year | 2026 |
| Award (this year) | $532,488 |
| NIH project number | 5R01CA296813-02 |
| Project ID | NIH-11312693 on NIH RePORTER |
Who could benefit from this research
✓Could help
Patients with newly diagnosed or recurrent CMV-expressing pediatric or adult brain tumors (e.g., DMG, HGG, MB, EPN) who meet study criteria.
✕Less likely to help
Some patients may not respond to immunotherapy or may experience immune-related side effects.
What this research studies
This trial uses a CMV-targeted peptide vaccine (PEP-CMV) combined with nivolumab to stimulate the immune system against brain tumors that express CMV proteins. It builds on a prior Phase I study showing immune responses and potential clinical benefit, and aims to recruit patients with newly diagnosed or recurrent diffuse midline glioma, high-grade glioma, medulloblastoma, and ependymoma. Participants likely undergo vaccine administration, immune monitoring, and standard cancer care, with safety and early signals of efficacy being tracked. The study seeks to understand whether adding a PD-1 blocker can enhance vaccine-induced anti-tumor immunity and improve outcomes.
Why it matters
Potential benefit: If successful, patients could experience stronger anti-tumor immune responses and potentially longer survival.
How similar studies have gone: Earlier Phase I results showed immune responses and some tumor control, suggesting potential but not guaranteed benefit.
Where this research is happening
-
Washington University
Saint Louis, United States Active
Researchers
- Principal investigator: Thompson, Eric — Washington University
- Study coordinator: Thompson, Eric
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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.