CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
K27M peptide +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02960230
NCT02960230Phase 2Completed
CompareCT.gov

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

Sabine Mueller, MD, PhD·interventional·Posted Nov 9, 2016·Updated Jan 22, 2025

In Brief

A Phase 2 clinical trial evaluating K27M peptide and Nivolumab for Diffuse Intrinsic Pontine Glioma and 2 related conditions. Completed, enrolled 50 participants across 15 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Intrinsic Pontine Glioma, Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
CountriesSwitzerland, United States
CollaboratorsThe V Foundation for Cancer Research, Pacific Pediatric Neuro-Oncology Consortium, Bristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 9, 2016
Enrollment StartNov 18, 2016
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 9.6 years ago

Interventions

K27M peptidebiological

K27M peptide vaccine, combined with Tetanus Toxoid peptide, emulsified in montanide. Poly-ICLC will be given concurrently

Nivolumabdrug

anti-programmed cell death protein 1 (PD-1) monoclonal antibody