drugset / Trial / NCT02960230
H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas
Phase 1/2
Completed
50 enrolled
Sabine Mueller, MD, PhD
Bristol-Myers Squibb · collabPacific Pediatric Neuro-Oncology Consortium · collabThe V Foundation for Cancer Research · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is 3-arm, multicenter study that will be conducted through the Pacific Pediatric Neuro-oncology Consortium (PNOC). This study will assess the safety and immune activity of a synthetic peptide vaccine specific for the Histone 3 lysine27-to-methionine (H3.3K27M) epitope given in combination with poly-ICLC and the H3.3K27M epitope given in combination with poly-ICLC and the PD-1 inhibitor, nivolumab, in HLA-A2 (02:01)+ children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or other midline gliomas that are positive for H3.3K27M.
Timeline
- Start
- 2016-11-18
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | K27M peptide | Vaccine | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |
| Background | Hiltonol | Other / unclassified | — | — |
| Background | Tetanus Toxoid peptide | Peptide | — | — |