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

Conditions

• Newly Diagnosed H3-mutated Glioma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tecentriq 1200 MG in 20 ML Injection — DRUG
  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.
• H3K27M peptide vaccine — BIOLOGICAL
  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.
• Imiquimod (5%) — OTHER
  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.

Study Details

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.

Key Dates

First listed

Mar 22, 2021

Start date

Feb 15, 2023

Status verified

Aug 2025

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Standard patient cohort
  All fifteen patients will receive in total 11 doses of H3K27M peptide vaccine starting with standard radiotherapy (RT) and 14 doses of the human anti-PD-L1 antibody Atezolizumab/ Tecentriq® (every three weeks, q3w) starting four weeks after completion of RT. The first 3 vaccines will be given bi-weekly (q2w) in combination with RT. One dose of vaccination will be given at the beginning of recovery (RE) period following RT. Vaccines 5-11 (q6w) will be initiated with Atezolizumab after completion of RE. The H3K27M peptide vaccine is administered in combination with topical Imiquimod that serves as an adjuvant. For safety reasons, the first three patients will be enrolled sequentially: Each patient will receive the first vaccination at the earliest 28 days after the previous patient has received the first vaccination.

Primary Outcome Measure

Assessment of safety of repeated fixed dose vaccinations with the H3K27M peptide vaccine administered with radiotherapy and Atezolizumab in patients with H3K27M-mutant gliomas. Primary safety endpoint is the Regime Limiting Toxicity (RLT). [ Time Frame: Through study completion, an average of one year ]