New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study (NCT06622434) | Clinical Trial Compass
RecruitingPhase 1/2
New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study
France35 participantsStarted 2024-11-08
Plain-language 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
* 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cycles of temozolomide. Radiation therapy must have been completed 28 to 45 days prior to the first study treatment
* Karnofsky Performance Status ≥ 60%
* Phase 1 only: Patients must be human leukocyte antigen (HLA)-A2 positive.
* Phase 1 only: PTPRZ1 expression in the tumor
* Available tumor tissue for post hoc (retrospective) assessment of TERT promoter mutations and MGMT promoter methylation status
* Life expectancy ≥ 3 months
* Adequate organ function laboratory values within 15 days before initiation of treatment (see table in section 6.1)
* Women or Male of childbearing potential (WOCBP) must use contraceptive methods during and for 180 days after the last dose of temozolomide or up to 120 days after the last dose of vaccine, whichever is longer (see section 6.3). No sperm donation during the study and until 7 months after the end of the treatment period.
* Patient affiliated to the social security scheme
Exclusion Criteria:
* 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
* Patients receivin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) for Phase 1
Timeframe: 2 months
2
anti-TERT specific T cell responses (safety/efficay) for Phase 2