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A Phase 3 Randomized Double-blind, Controlled Study of ICT-107 With Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy
ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells.
Details
| Lead sponsor | Precision Life Sciences Group |
|---|---|
| Phase | Phase 3 |
| Status | SUSPENDED |
| Enrolment | 234 |
| Start date | 2024-12 |
| Completion | 2025-12 |
Conditions
- Glioblastoma Multiforme
Interventions
- ICT-107
- Placebo
Primary outcomes
- Overall survival — 46 months
Overall survival (OS) of subjects treated with ICT-107 and standard of care (radiation (RT) and TMZ) vs. placebo control and standard of care (RT and TMZ)
Countries
United States, Austria, Canada