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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

February 15, 2023

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

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.

Trial Locations (8)

1307

Clinic and Polyclinic for Neurosurgery, University Hospital Carl Gustav Carus Dresden, Dresden

10117

Department of Neurosurgery with Pediatric Neurosurgery, Berlin

45147

Neurooncology Department, University Hospital Essen, Essen

53127

Clinical Neuro-Oncology Section, University Hospital Bonn (UKB), Bonn

60528

Dr. Senckenberg Institute for Neurooncology, University Hospital Frankfurt, Frankfurt am Main

68167

University Medical Center Mannheim, Department of Neurology, Mannheim

69120

Department of Neurology and Polyclinic, Universitiy Clinic Heidelberg, Heidelberg

72076

University Clinic Tuebingen, Neurological Clinic, Department of Neurology, Tübingen

All Listed Sponsors
collaborator

Johannes Gutenberg University Mainz

OTHER

collaborator

Charite University, Berlin, Germany

OTHER

collaborator

Roche Pharma AG

INDUSTRY

collaborator

German Cancer Aid

OTHER

lead

German Cancer Research Center

OTHER