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

NCT06622434 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Newly Diagnosed Glioblastoma

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).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Antoine CARPENTIER, Pr · APHP- Hôpital Saint Louis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-08
Primary Completion
2028-03-08
Completion
2028-03-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06622434 on ClinicalTrials.gov