New cancer vaccine for glioblastoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Neurology, Hopital de la Salpêtrière
  Paris, Idf, France Recruiting
• Department of Neurology, Hopital Saint louis (APHP)
  Paris, France Recruiting
• Neuro-oncology Department, La Timone Hospital
  Marseille, Provence-Alpes-Côte d'Azur Region, France Not yet recruiting

Study contacts

• Study coordinator: Antoine CARPENTIER, Pr
• Email: antoine.carpentier@aphp.fr
• Phone: 0171207466

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Silevertinib plus temozolomide for newly diagnosed GBM with unmethylated MGMT and EGFRvIII

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• Anterior (front) temporal lobe removal for temporal glioblastoma

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• Nivolumab with or without relatlimab for newly diagnosed IDH‑wildtype glioblastoma

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  Recruiting at 4 sites Phase 2 Duke University · New York, New York and 3 other locations · NCT06816927

• Personalized drug screening for glioblastoma treatment

  This study is testing if personalized combinations of FDA-approved drugs can improve treatment for people with newly diagnosed glioblastoma when used with standard therapy.

  Recruiting Early Phase 1 Swedish Medical Center · Seattle, Washington · NCT05380349

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.