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RECRUITING
NCT06622434
PHASE1/PHASE2

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2024-11-08

Completion Date

2028-03-08

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

immunization

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