NCT02960230

H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas

H3.3K27M Specific Peptide Vaccine Combined With Poly-ICLC With and Without PD-1 Inhibition Using Nivolumab for the Treatment of Newly Diagnosed HLA-A2 (02:01)+ H3.3K27M Positive Diffuse Intrinsic Pontine Glioma (DIPG) and Newly Diagnosed HLA-A2 (02:01)+ H3.3K27M Positive Gliomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sabine Mueller, MD, PhD · Academic / Other
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants who are eligible will receive a specific peptide vaccine, along with a helper drug called poly-ICLC, in combination with nivolumab, every 3 weeks for the first 6 months of treatment. Participants will be monitored routinely by laboratory assessments, physical evaluation, vital signs, and MRI. Participants who tolerate therapy well and have stable or improved disease after 6 months of treatment can continue to receive treatment, nivolumab continuing every 3 weeks but vaccine and poly-ICLC now every 6 weeks, for a total of 96 weeks of treatment.

Conditions

• Diffuse Intrinsic Pontine Glioma
• Glioma
• Diffuse Midline Glioma, H3 K27M-Mutant

Interventions

Type	Name	Description
BIOLOGICAL	K27M peptide	K27M peptide vaccine, combined with Tetanus Toxoid peptide, emulsified in montanide. Poly-ICLC will be given concurrently
DRUG	Nivolumab	anti-programmed cell death protein 1 (PD-1) monoclonal antibody

Timeline

• Start date: 2016-11-18
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2016-11-09
• Last updated: 2025-01-22
• Results posted: 2025-01-22

Locations

15 sites across 2 countries: United States, Switzerland

Regulatory

• FDA-regulated drug study