Glioblastoma Multiforme of BrainPhase 1GLIO-XS15NCT04842513
Multi Peptide Vaccination with XS15 in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed Glioblastoma
A Phase 1 study testing Multipeptide plus XS15 in people with Glioblastoma Multiforme of Brain, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme of Brain
- What is being tested?
- Multipeptide plus XS15
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2021to 31 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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)
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- 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
- Patient is not on steroids or on stable or decreasing steroid levels not exceeding 2 mg/day dexamethasone (or equivalent doses of other steroids) during the last 3 days prior to first dose of IMP (Vaccination 1)
- Absolute lymphocyte count (ALC) >0.5 x109/L (re-screening of lymphocyte counts is allowed at day of vaccination)
- Ability of subject to understand and the willingness to sign written informed consent for study participation prior to any study related assessments/procedures. Able to adhere to the study visit schedule and other protocol requirements.
- Female Patient of childbearing potential1 and male patients with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during treatment and for 30 days after the end of treatment. According to the CTFG Recommendations highly effective contraceptive methods are:
- combined hormonal contraceptive associated with inhibition of ovulation (oral,-intravaginal,-transdermal)
- progestogen-only hormonal contraception associated with inhibition of ovulation (pral injectable, implantable)
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion,
- vasectomized partner2,
- sexual abstinence3.
- Negative Covid 19 Quick Test
- Female subjects must abstain from breastfeeding during study participation and 30 days after study drug discontinuation.
- Male subjects must refrain from donating semen or sperm while on study
- All subjects must agree to refrain from donating blood while on study drug and for 30 days after discontinuation from this study treatment.
- All subjects must agree not to share medication.
Who cannot join
- Subjects presenting with any of the following criteria will not be included in the trial:
- 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.
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- Participation in other clinical trials or observation period of competing trials.
- Platelet count decrease < 75 x109/L
- Bilirubin > 1.5 x ULN (upper limit of normal according to the performing lab's reference range)
- ALT4 > 3 x ULN
- AST5 > 3 x ULN
- GGT > 2.5 x ULN
- Serum creatinine increased > 1.5 x ULN
- HIV infection or active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients' blood or tissue (e.g. rabies).
- Prior therapy for glioma (except surgery and steroids) including but not limited to carmustine wafers and immunotherapy. Note: History of low grade glioma that did not require prior treatment with chemotherapy or radiotherapy is not an exclusion criterion.
- Clinically relevant autoimmune diseases (with the exception of thyroid diseases).
- Immunosuppression, not related to prior treatment for malignancy, or prior drug reaction
- Other vaccinations with active or attenuated viruses should be restricted during the peptide vaccination period.
- Enzyme-inducing antiepileptic drugs
- Patients with prior stem cell transplantation or solid organ transplantation.
- Any condition that in the judgment of the investigator interferes with the probability that an individual patient may receive and benefit from APVAC vaccinations (e.g. high risk of early disease progression / recurrence; immunocompromised status; anticipated compliance problems)
- Serious illness or condition, which according to the investigator, poses an undue risk for the patient when participating in the trial, including, but not limited to, any of the following:
- Clinically symptomatic cardiovascular disease:(New York Heart Association class III-IV congestive heart failure)
- Symptomatic peripheral vascular disease (Definition z.B. > Stage III)
- Severe pulmonary dysfunction (Definition: z.B. requirement for oxygen supplement
- Severe diabetes
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 5 years unless the patient has been disease-free for 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Multipeptide plus XS15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multipeptide plus XS15Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Multipeptide plus XS15 | Experimental | 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. Receives: Drug: Multipeptide plus XS15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: at 30 days, 60 days and 90 days from first vaccination and at 12 months after last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start3 May 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme of BrainStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghazaleh Tabatabai, Prof, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842513
- Sponsor's protocol ID
- 2020-003357-30
- Acronym
- GLIO-XS15
- Status last verified
- Dec 2023
- First submitted
- 1 Mar 2021
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04842513
- Acronym / sponsor ID
- GLIO-XS15 / 2020-003357-30
- Conditions
- Glioblastoma Multiforme of Brain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multipeptide plus XS15 | Experimental | Drug: Multipeptide plus XS15The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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)
- Histologically confirmed, newly diagnosed IDH1-wildtype glioblastoma (astrocytoma WHO grade IV)
- MGMT gene promoter methylation
Key exclusion criteria (27 listed)
- Subjects presenting with any of the following criteria will not be included in the trial:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multipeptide plus XS15The 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. | Drug | Multipeptide plus XS15 |
Primary outcome
Adevrse Events
Time frame: at 12 months after last vaccination
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.
Change of immunogenicity parameter from baselien
Time frame: at 30 days, 60 days and 90 days from first vaccination and at 12 months after last vaccination
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghazaleh Tabatabai, Prof principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multipeptide plus XS15 in people with Glioblastoma Multiforme of Brain, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adevrse Events (time frame: at 12 months after last vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.