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

NCT02960230 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-22

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • The V Foundation for Cancer Research

    collaborator OTHER

  • Pacific Pediatric Neuro-Oncology Consortium

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Sabine Mueller, MD, PhD

    lead OTHER

Principal Investigators

  • Sabine Mueller, MD, PhD, MAS · University of California, San Francisco

  • Hideho Okada, MD, PhD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-18
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States
  • Switzerland

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02960230 on ClinicalTrials.gov