Clinical trial for Newly Diagnosed Glioblastoma
Official title New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study
ClinicalTrials.gov ID: NCT06622434
What this study is testing
What is immunization?
immunization is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for newly diagnosed glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- Karnofsky Performance Status ≥ 60%
You likely can't join 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
See the full eligibility criteria
- 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...
- 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
- Life expectancy ≥ 3 months
- Adequate organ function laboratory values within 15 days before initiation of treatment (see table in section 6.1)
- Women or Male of childbearing potential (WOCBP) must use contraceptive methods during and for 180 days after the last dose of temozolomide or up to 120 days after the last dose of vaccine, whichever is longer (see...
- Patient affiliated to the social security scheme
- 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...)
- Previous treatment with bevacizumab or other Vascular Endothelial Growth Factor (VEGF) antagonists
- Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study.
- Uncontrolled active systemic fungal, bacterial, viral, or other infection within the previous 4 weeks or requirement for intravenous (IV) antibiotics within the last two weeks
- Breast-feeding or pregnant women.
- Contra-indications to IRM
- Contra-indications to investigational medicinal product and/or to auxiliary medicinal products
- Participation to another treatment clinical trial, clinical investigation or another treatment study or being in the exclusion period at the end of a previous study
- Patient unable to follow the procedures and constraints of the protocol
- Patient under legal protection (protection of the court, or in curatorship or guardianship).
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Idf, France
- Marseille, Provence-Alpes-Côte d'Azur Region, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Idf, France; Marseille, Provence-Alpes-Côte d'Azur Region, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.