RecruitingPhase 1Phase 2NCT06622434

New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study

New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study (NAVIG-1)


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

35 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

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 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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new personalized cancer vaccine for people with glioblastoma (an aggressive brain tumor) who have already completed standard treatment (radiation plus chemotherapy with temozolomide). The vaccine is designed to train the immune system to recognize and attack leftover tumor cells. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with glioblastoma confirmed by biopsy - You completed radiation (at least 45 Gy) and temozolomide chemotherapy, finishing 28–45 days before starting the study - You have reasonable physical functioning (Karnofsky score 60% or above) - You have adequate organ function - (Phase 1 only) You have a specific immune marker called HLA-A2 and a particular protein (PTPRZ1) expressed in your tumor **You may NOT be eligible if...** - Your cancer is not confirmed glioblastoma - You have not completed the required prior treatment - Your organ function is inadequate - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALimmunization

One month after completion of concurrent radiochemotherapy, patients will be immunized during the adjuvant phase of monthly temozolomide with subcutaneous injections of the vaccine formulation (D0, W2, W4, W6, and then every 2 months until progression) consisting of 2 tumor antigens (TERT and PTPRZ1) adjuvanted with synthetic melanin and a TLR9 agonist (CpG-ODN).


Locations(5)

Department of Neurology, University Hospital of Besançon

Besançon, Bourgogne-Franche-Comté, France

Medical Oncology Department, Eugène Marquis Centre

Rennes, Brittany Region, France

Department of Neurology, Hopital de la Salpêtrière

Paris, Idf, France

Neuro-oncology Department, La Timone Hospital

Marseille, Provence-Alpes-Côte d'Azur Region, France

Department of Neurology, Hopital Saint louis (APHP)

Paris, France

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NCT06622434


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