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

Multi Peptide Vaccination with Pam3Cys-GDPKHPKSF (XS15) As an Immunomodulator in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed HLA-A2-positive MGMT-methylated Glioblastoma

NCT04842513•University Hospital Tuebingen

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects meeting all of the following criteria will be considered for admission to the trial:
•For screening phase: (Consent C1)
•1\. .Must be ≥ 18 years at the time of signing the informed consent 2. Suspected Glioblastoma (presenting with a MRI suggestive of glioblastoma and eligible for gross or subtotal resection and standard radiotherapy with temozolomide) For Vaccination phase (Consent C2)
•1. Histologically confirmed, newly diagnosed IDH1-wildtype glioblastoma (astrocytoma WHO grade IV)
•2. MGMT gene promoter methylation
•3. HLA phenotype HLA-A\*02:01 (as determined by a PCR-based 4-digit typing method)
•4. Gross or subtotal resection (20%, as determined by MRI)
•5. Postoperative MRI
•6. KPS ≥70%
•7. Life expectancy \> 6 months
+17 more criteria

Exclusion Criteria

•Subjects presenting with any of the following criteria will not be included in the trial:
•1. Karnofsky performance score (KPS) \< 70%
•2. Patient who cannot undergo MRI assessments
•3. Only Biopsy available
•4. Women during pregnancy and lactation.
•5. 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.
•6. Participation in other clinical trials or observation period of competing trials.
•7. Platelet count decrease \< 75 x109/L
•8. Bilirubin \> 1.5 x ULN (upper limit of normal according to the performing lab's reference range)
•9. ALT4 \> 3 x ULN
+17 more criteria

Locations (1)

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

Key Dates

Start Date

May 3, 2021

Primary Completion Date

July 31, 2024

Completion Date

July 31, 2024

Last Updated

January 10, 2025

Enrollment

ACTUAL participants

Conditions

Glioblastoma Multiforme of Brain

Interventions

Multipeptide plus XS15

DRUG

Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas

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GlioblastomaGlioblastoma Multiforme+2 more

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SUSPENDEDPHASE1

Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas

Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)

Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma

Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme