New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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 * To evaluate cardiac safety and monitor for the potential development of anti-melanin antibodies in a cohort of 8 patients enrolled in the Phase 2a study 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.
Sponsor: Assistance Publique - Hôpitaux de Paris
You may qualify if…
- ✓ age between 18 and 75 years old
- ✓ free, informed and written consent signed
- ✓ Histologically confirmed glioblastoma
- ✓ 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
- ✓ Karnofsky Performance Status ≥ 60%
- ✓ Phase 1 only: Patients must be human leukocyte antigen (HLA)-A2 positive.
- ✓ Phase 1 only: PTPRZ1 expression in the tumor
- ✓ Available tumor tissue for post hoc (retrospective) assessment of TERT promoter mutations and MGMT promoter methylation status
You may not qualify if…
- ✕ Known extracranial metastatic or leptomeningeal disease
- ✕ Grade 4 astrocytoma IDH mutant
- ✕ Steroid requirement \>10 mg prednisone daily (or equivalent) at time of inclusion
- ✕ Patients with prior malignancy active within the last 3 years
- ✕ Patients receiving immunomodulatory or immunosuppressive therapy
- ✕ Carmustine wafers (GliadelR) implantation during surgery
- ✕ Phase 1 only: patient eligible and willing to be treated with Optune (TTF fields)
- ✕ History of autoimmune disease (lupus, rheumatoid arthritis, inflammatory bowel disease...)
Source: ClinicalTrials.gov · NCT06622434 · last updated 2026-06-11