Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or… (NCT05938387) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma
Belgium, Germany37 participantsStarted 2023-06-01
Plain-language summary
This study is an open-label, first-in-human, dose-escalation study of CV09050101 mRNA vaccine (CVGBM) in patients with newly diagnosed "MGMT-unmethylated" Glioblastoma (GBM). Patients with isocitrate dehydrogenase (IDH)-wildtype astrocytoma with a molecular signature of "unmethylated" GBM are also eligible.
After surgical resection and completion of radiotherapy for GBM with or without chemotherapy, patients will receive CVGBM i.e. as monotherapy after radiotherapy with or without chemotherapy.
The study consists of a dose-escalation part (Part A) which completes enrollment in February 2024 and a dose-expansion part (Part B) which is anticipated to begin enrolling in June/July 2024.
Patients will receive a total of 7 administrations of CVGBM on Days 1, 8, 15, 29, 43, 57, and 71. At the discretion of the Investigator in alignment with the Sponsor's medical monitor the vaccinations may continue beyond Day 71 every 6 weeks until one year after the first CVGBM vaccination or upon disease progression or undue toxicity.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed, newly diagnosed GBM (CNS WHO Grade 4) and IDH-wildtype astrocytoma with a molecular signature of "unmethylated" GBM.
✓. Specific HLA genotype.
✓. Gross total or partial resection (i.e., ≥50% of tumor volume resected).
✓. Having completed radiotherapy with or without chemotherapy post-surgery at least 2 weeks before study treatment initiation with no signs of disease progression. Patients must have recovered from any radiotherapy or chemotherapy related side effects to ≤ Grade 1 (with the exception of ALC and WBC as per eligibility criteria). Pretreatment (and concomitant treatment) with TTFields therapy for GBM is allowed.
✓. Age ≥18 years.
✓. Karnofsky Performance Status (KPS) ≥70%.
✓. Life expectancy \>6 months.
✓. Absolute lymphocyte count (ALC) \>0.5 x109/L.
Exclusion criteria
✕. Abnormal (≥Grade 2 NCI-CTCAE v5.0) laboratory values for hematology, liver and renal function (serum creatinine). The following values apply as exclusion criteria:
What they're measuring
1
Incidence of treatment-related adverse events (TRAEs)
Timeframe: 1 year
2
Incidence of treatment-emergent adverse events (TEAEs)
Timeframe: 1 year
3
Incidence of serious adverse events (SAEs)
Timeframe: 1 year
4
Incidence of immune related adverse events (irAEs)
Timeframe: 1 year
5
Incidence of injection site reactions (ISRs)
Timeframe: 1 year
6
Incidence of clinically significant laboratory abnormalities per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0
Timeframe: 1 year
7
Incidence dose-limiting toxicities (DLTs)
Timeframe: Through the first 2 weeks of treatment
8
Severity of DLTs (Unit: Grading via NCI-CTCAE v5.0)