Newly diagnosed HLA-A2-positive MGMT-methylated glioblastoma patients will be vaccinated with a Multi peptide vaccination with Pam3Cys-GDPKHPKSF (XS15) as an immunomodulator in addition to standard postoperative radiation therapy and temozolomide chemotherapy to assess immunogenicity, efficacy, safety of the combination of multipeptide vaccination and the immune modulator XS15 emulsified in Montanide ISA 51 VG
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The vaccine will be applied by subcutaneous injection into the abdominal skin of the study patient. Vaccination will take place monthly (V1, V2 and V3). A total of three vaccinations will be performed. Peptide vaccines should be injected into the skin at the lower part of the abdomen of the patients. The exact site of vaccination (right or left) will be determined at the time of first vaccination and should not be changed during subsequent vaccinations.
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, Germany
Adevrse Events
The assessment of safety of the IMP will be accomplished by documentation of adverse events and grading according to CTCAE from first vaccination throughout the end of treatment, until 30 days after last vaccination.
Time frame: at 12 months after last vaccination
Change of immunogenicity parameter from baselien
The assessment of immunogenicity is the central biological efficacy endpoint of the clinical trial. Measurements of the induction of T-cell response after vaccination at 30 days, 60 days and 90 days from first vaccination and at 12 months after last vaccinationcompared to baseline as determined by ELISpot
Time frame: at 30 days, 60 days and 90 days from first vaccination and at 12 months after last vaccination
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