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Multi Peptide Vaccination with XS15 in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed Glioblastoma

NCT04842513 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-01-10

No results posted yet for this study

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

Conditions

  • Glioblastoma Multiforme of Brain

Interventions

DRUG

Multipeptide plus XS15

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.

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Ghazaleh Tabatabai, Prof · University Hospital Tuebingen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2024-07-31
Completion
2024-07-31

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 NCT04842513 on ClinicalTrials.gov