New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study
Recruiting
Phase 1
Phase 2
Interventional Study
Newly Diagnosed Glioblastoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 35 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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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 a…
Trial Locations
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Eligibility Criteria
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 cycle…
Contacts