Multi Peptide Vaccination with XS15 in Addition to Standard Postoperative Radiation Therapy and T… (NCT04842513) | Clinical Trial Compass
CompletedPhase 1
Multi Peptide Vaccination with XS15 in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed Glioblastoma
Germany15 participantsStarted 2021-05-03
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. HLA phenotype HLA-A\*02:01 (as determined by a PCR-based 4-digit typing method)
✓. Gross or subtotal resection (20%, as determined by MRI)
✓. Postoperative MRI
✓. KPS ≥70%
✓. Life expectancy \> 6 months
✓. Patient is a candidate for and willing to receive standard radiation therapy with TMZ followed by maintenance TMZ cycles
Exclusion criteria
✕. Karnofsky performance score (KPS) \< 70%
✕. Patient who cannot undergo MRI assessments
✕. Only Biopsy available
✕. Women during pregnancy and lactation.
✕. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
✕. Participation in other clinical trials or observation period of competing trials.
What they're measuring
1
Adevrse Events
Timeframe: at 12 months after last vaccination
2
Change of immunogenicity parameter from baselien
Timeframe: at 30 days, 60 days and 90 days from first vaccination and at 12 months after last vaccination