New cancer vaccine for glioblastoma patients
New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study (NAVIG-1)
This study is testing a new cancer vaccine for people with newly diagnosed glioblastoma to see if it can help boost their immune response after standard treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | bevacizumab, Radiation, prednisone, chemotherapy, Immunotherapy |
| Locations | 5 sites (Besançon, Bourgogne-Franche-Comté and 4 other locations) |
| Trial ID | NCT06622434 on ClinicalTrials.gov |
What this trial studies
This phase 1/2a trial evaluates the safety and immunological efficacy of a cancer vaccine targeting two glioma-associated antigens in patients with newly diagnosed glioblastoma. Participants will undergo standard treatment, including surgical resection and radio-chemotherapy, followed by immunotherapy starting four weeks after radiotherapy. The vaccine is designed to induce strong cellular immune responses and will be administered through subcutaneous injections over a 12-month period. Efficacy will be assessed through T cell responses and MRI evaluations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed glioblastoma who have completed initial radiotherapy and are HLA-A2 positive.
Not a fit: Patients with glioblastoma who do not express PTPRZ1 in their tumors or have a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could enhance the immune response against glioblastoma, potentially improving patient outcomes.
How similar studies have performed: While there have been studies on cancer vaccines, this specific approach targeting TERT and PTPRZ1 in glioblastoma is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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 * 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 section 6.3). No sperm donation during the study and until 7 months after the end of the treatment period. * Patient affiliated to the social security scheme Exclusion Criteria: * 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 interventional clinical trial, clinical investigation or another interventional 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).
Where this trial is running
Besançon, Bourgogne-Franche-Comté and 4 other locations
- Department of Neurology, University Hospital of Besançon — Besançon, Bourgogne-Franche-Comté, France (Not_yet_recruiting)
- Medical Oncology Department, Eugène Marquis Centre — Rennes, Brittany Region, France (Not_yet_recruiting)
- Department of Neurology, Hopital de la Salpêtrière — Paris, Idf, France (Recruiting)
- Neuro-oncology Department, La Timone Hospital — Marseille, Provence-Alpes-Côte d'Azur Region, France (Not_yet_recruiting)
- Department of Neurology, Hopital Saint louis (APHP) — Paris, France (Recruiting)
Study contacts
- Study coordinator: Antoine CARPENTIER, Pr
- Email: antoine.carpentier@aphp.fr
- Phone: 0171207466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.