Health TrialsbyHealthPanel

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

ConditionNewly Diagnosed Glioblastoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 * To evaluate cardiac safety and monitor for the potential development of anti-melanin antibodies in a cohort of 8 patients enrolled in the Phase 2a study

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • immunization

    Biological/Vaccine

    One month after glioblastoma patients have completed the initial phase of treatment with concurrent radiochemotherapy, patients will be immunized during the adjuvant phase of monthly temozolomide (5 days per month for 6 months). Immunizations will follow the standard schedule of a priming phase (D0, W2, W4, and W6) followed by a boost phase with one immunization every 2 months until progression, unacceptable toxicity, withdrawal of consent, or study end (at 12 months), whichever occurs first.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: A52-Mel; A49-Mel (for Phase1 only) and Litenimod, as an adjuvantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD) for Phase 1

the maximum tolerated dose (MTD) based on the occurrence of dose limiting toxicity (DLT)

Time frame
2 months
2

anti-TERT specific T cell responses (safety/efficay) for Phase 2

anti-TERT specific T cell responses by using IFN-gamma ELISPOT

Time frame
2 months

Secondary outcomes

1

Evolution of anti-PTPRZ1 specific T cell responses

anti-PTPRZ1 specific T cell responses by using IFN-gamma ELISPOT

Time frame
over time
2

Overall survival

The time interval from the start of treatment to the date of death from any cause.

Time frame
12 months
3

Progression free survival

Tumor response will be assessed using RANO 2.0 criteria

Time frame
12 months
4

the evaluation of quality of life

EORTC-QLQC30 questionnaire and BN20 module will be completed by each patient (Not all= 1; A little=2; Quite a bit= 3 ; Very Much=4)

Time frame
5 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

ALTEVAX SAS

Collaborator

Source ClinicalTrials.gov
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