OncoMatch/Clinical Trials/NCT06622434
New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study
Is NCT06622434 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies immunization for newly diagnosed glioblastoma.
Treatment: immunization — This phase I/II trial evaluates the safety and the immunological efficacy of a cancer vaccine against 2 glioma-associated antigens in newly-diagnosed glioblastomas. The objectives of this study are as follows: Primary objective * phase 1: * to assess the maximum tolerated dose (MTD) and select the recommend Phase 2a dose * phase 2a: * to assess anti- TERT specific T cell responses at 2 months at the selected dose level Secondary objectives: * To assess Short and long-time immunological safety * To assess Evolution of anti-PTPRZ1 and anti-TERT immune T cell responses over time * To assess Progression free survival (RANO 2.0 criteria) * To assess Overall survival * To assess Quality of life by EORTC QLQ30 and BN20 questionnaires as well as objective of ancillary study: to determine the mechanism of action of potential tumour escape in GBM (T-cell lymphocyte phenotype; antigen expression and checkpoint inhibitors on tumour cells at relapse, if available), analysis of circulating antibodies against TERT epitope and/or melanin, and identification of predictive biomarkers of response. Ultimately, this trial together will lead to the implementation of future phase III trial in GBM. All patients enrolled in the study will receive standard treatment consisting of surgical resection of the tumor followed by radio-chemotherapy. Immunotherapy will begin 4 weeks after the completion of radiotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: HLA-A A2 positive
Phase 1 only: Patients must be human leukocyte antigen (HLA)-A2 positive.
Required: PTPRZ1 expression
Phase 1 only: PTPRZ1 expression in the tumor
Prior therapy
Must have received: radiation therapy — concurrent with temozolomide
Patients previously treated with concurrent radiotherapy (at least 45 Gy) with concomitant temozolomide, before the beginning of the 6 additional monthly cycles of temozolomide. Radiation therapy must have been completed 28 to 45 days prior to the first study treatment
Must have received: alkylating agent (temozolomide) — concurrent with radiotherapy
Patients previously treated with concurrent radiotherapy (at least 45 Gy) with concomitant temozolomide, before the beginning of the 6 additional monthly cycles of temozolomide.
Cannot have received: VEGF antagonist (bevacizumab)
Previous treatment with bevacizumab or other Vascular Endothelial Growth Factor (VEGF) antagonists
Cannot have received: nitrosourea (carmustine wafers (GliadelR))
Carmustine wafers (GliadelR) implantation during surgery
Lab requirements
Blood counts
Adequate organ function laboratory values within 15 days before initiation of treatment (see table in section 6.1)
Kidney function
Adequate organ function laboratory values within 15 days before initiation of treatment (see table in section 6.1)
Liver function
Adequate organ function laboratory values within 15 days before initiation of treatment (see table in section 6.1)
Adequate organ function laboratory values within 15 days before initiation of treatment (see table in section 6.1)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify