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A MultIceNTER Phase I Peptide VaCcine Trial for the Treatment of H3-Mutated Gliomas

NCT04808245 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-22

No results posted yet for this study

Summary

The study "A MultIceNTER Phase I Peptide VaCcine Trial to Exploit NeoePitope-Specific T Cells for the Treatment of H3K27M-Mutated Gliomas - (INTERCEPT H3)" is a non-controlled, open-label, single arm, multicenter phase I trial involving patients with gliomas carrying an H3.1K27M or H3.3K27M mutation.

Conditions

  • Newly Diagnosed H3-mutated Glioma

Interventions

DRUG

Tecentriq 1200 MG in 20 ML Injection

One vial of Tecentriq® (1200 mg) will be administered as an intravenous (i.v.) infusion over 60 minutes every 3 weeks starting 4 weeks after radiotherapy. If the first infusion is tolerated, all subsequent infusions will be delivered over 30 minutes.

BIOLOGICAL

H3K27M peptide vaccine

The H3K27M peptide vaccine is injected subcutaneously (s.c.). For a single vaccination 300 μg of the peptide will be emulsified in a total volume of 1 ml.

OTHER

Imiquimod (5%)

One sachet of Aldara® cream (250 mg) will be applied to an area of 5 x 5 cm around the injection site of the H3K27M peptide vaccine 15 min after vaccination and left on the skin for approximately 8 hours according to the instructions in the SmPC. 24 hours after the vaccination a second sachet of Aldara® will be applied by the patient as instructed above and left on the skin for approximately 8 hours.

Sponsors & Collaborators

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Roche Pharma AG

    collaborator INDUSTRY

  • German Cancer Aid

    collaborator OTHER

  • German Cancer Research Center

    lead OTHER

Principal Investigators

  • Michael Platten, Prof. · German Cancer Research Center Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Germany

Study Locations

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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 NCT04808245 on ClinicalTrials.gov