We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi Peptide Vaccination With XS15 in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed Glioblastoma (GLIO-XS15)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04842513
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief 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

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme of Brain Drug: Multipeptide plus XS15 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 3, 2021
Estimated Primary Completion Date : May 2, 2023
Estimated Study Completion Date : May 2, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  8. Patient is a candidate for and willing to receive standard radiation therapy with TMZ followed by maintenance TMZ cycles
  9. 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)
  10. Absolute lymphocyte count (ALC) >0.5 x109/L (re-screening of lymphocyte counts is allowed at day of vaccination)
  11. 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.
  12. 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.
  13. Negative Covid 19 Quick Test
  14. Female subjects must abstain from breastfeeding during study participation and 30 days after study drug discontinuation.
  15. Male subjects must refrain from donating semen or sperm while on study
  16. All subjects must agree to refrain from donating blood while on study drug and for 30 days after discontinuation from this study treatment.
  17. All subjects must agree not to share medication.

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
    10. AST5 > 3 x ULN
    11. GGT > 2.5 x ULN
    12. Serum creatinine increased > 1.5 x ULN
    13. 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).
    14. 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.
    15. Clinically relevant autoimmune diseases (with the exception of thyroid diseases).
    16. Immunosuppression, not related to prior treatment for malignancy, or prior drug reaction
    17. Other vaccinations with active or attenuated viruses should be restricted during the peptide vaccination period.
    18. Enzyme-inducing antiepileptic drugs
    19. Patients with prior stem cell transplantation or solid organ transplantation.
    20. 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)
    21. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842513


Contacts
Layout table for location contacts
Contact: Ghazaleh Tabatabai, Prof +497071/29-83269 ghazaleh.tabatabai@uni-tuebingen.de

Locations
Layout table for location information
Germany
University Hospital Tübingen Recruiting
Tübingen, BW, Germany, 72076
Contact: Ghazaleh Tabatabai, Prof    0049707129 ext 83269    ghazaleh.tabatabai@uni-tuebingen.de   
Contact: Ghazaleh P Tabatabai, Prof         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Layout table for investigator information
Principal Investigator: Ghazaleh Tabatabai, Prof University Hospital Tuebingen
Layout table for additonal information
Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04842513    
Other Study ID Numbers: 2020-003357-30
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue