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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologically confirmed, newly diagnosed IDH1-wildtype glioblastoma (astrocytoma WHO grade IV)
. MGMT gene promoter methylation
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adevrse Events

Timeframe: at 12 months after last vaccination

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

Trial details

NCT IDNCT04842513

SponsorUniversity Hospital Tuebingen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Glioblastoma Multiforme of Brain trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologically confirmed, newly diagnosed IDH1-wildtype glioblastoma (astrocytoma WHO grade IV)
. MGMT gene promoter methylation
. 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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria