Actively Recruiting
New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-20
35
Participants Needed
5
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Signed free, informed, and written consent
- Histologically confirmed glioblastoma
- Completed concurrent radiotherapy (at least 45 Gy) with temozolomide before starting 6 additional monthly temozolomide cycles
- Radiotherapy completed 28 to 45 days before first study treatment
- Karnofsky Performance Status of 60% or higher
- Phase 1 only: HLA-A2 positive
- Phase 1 only: PTPRZ1 expression present in tumor tissue
- Available tumor tissue for retrospective analysis of TERT promoter mutations and MGMT promoter methylation
- Life expectancy of 3 months or more
- Adequate organ function laboratory tests within 15 days before treatment start
- Women or men of childbearing potential must use contraception during and up to 180 days after last temozolomide dose or up to 120 days after last vaccine dose, whichever is longer
- No sperm donation during study and until 7 months after treatment ends
- Affiliated to social security scheme
You will not qualify if you...
- Known extracranial metastatic or leptomeningeal disease
- Grade 4 astrocytoma with IDH mutation
- Steroid use greater than 10 mg prednisone daily at inclusion
- Active malignancy within last 3 years
- Receiving immunomodulatory or immunosuppressive therapy
- Carmustine wafers implanted during surgery
- Phase 1 only: eligible and willing to use Optune (TTF fields)
- History of autoimmune diseases such as lupus, rheumatoid arthritis, or inflammatory bowel disease
- Previous treatment with bevacizumab or other VEGF antagonists
- Medical or psychiatric conditions making patient unsuitable
- Uncontrolled active systemic infections within 4 weeks or requiring IV antibiotics within 2 weeks
- Pregnant or breastfeeding women
- Contraindications to MRI or investigational and auxiliary medicinal products
- Participation in another interventional clinical trial or study exclusion period
- Inability to follow study procedures and requirements
- Under legal protection or guardianship
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Trial Site Locations
Total: 5 locations
1
Department of Neurology, University Hospital of Besançon
Besançon, Bourgogne-Franche-Comté, France, 25030
Not Yet Recruiting
2
Medical Oncology Department, Eugène Marquis Centre
Rennes, Brittany Region, France, 35000
Not Yet Recruiting
3
Department of Neurology, Hopital de la Salpêtrière
Paris, Idf, France, 75013
Actively Recruiting
4
Neuro-oncology Department, La Timone Hospital
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
Not Yet Recruiting
5
Department of Neurology, Hopital Saint louis (APHP)
Paris, France, 75010
Actively Recruiting
Research Team
A
Antoine CARPENTIER, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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