New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study
Condition(s) studied
Investigational drug(s) / intervention(s)
immunization: One month after glioblastoma patients have completed the initial phase of treatment with concurrent radiochemotherapy, patients will be immunized during the adjuvant phase of monthly temozolomide (5 days per month for 6 months). Immunizations will follow the standard schedule of a priming phase (D0, W2, W4, and W6) followed by a boost phase with one immunization every 2 months until progression, unacceptable toxicity, withdrawal of consent, or study end (at 12 months), whichever occurs first.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Maximum tolerated dose (MTD) for Phase 1 — 2 months
the maximum tolerated dose (MTD) based on the occurrence of dose limiting toxicity (DLT) - anti-TERT specific T cell responses (safety/efficay) for Phase 2 — 2 months
anti-TERT specific T cell responses by using IFN-gamma ELISPOT
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Neurology, Hopital de la Salpêtrière | Paris | Idf | Recruiting |
| Neuro-oncology Department, La Timone Hospital | Marseille | Provence-Alpes-Côte d'Azur Region | Not Yet Recruiting |
| Department of Neurology, Hopital Saint louis (APHP) | Paris | France | Recruiting |
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06622434 on ClinicalTrials.gov ↗ ← All trials in France