Title: Phase 3 Randomized, Double-blind, Controlled Study of ICT-107 in Glioblastoma1
Description: For this randomized phase 3 study (ClinicalTrials.gov Identifier: NCT02546102), researchers are attempting to determine the clinical efficacy of ICT-107, a dendritic cell vaccine, among patients with newly diagnosed glioblastoma. ICT-107 may be effective for activating cytotoxic T cells to target tumor cells.
There are 2 trial arms: in arm 1, patients will receive ICT-107 with temozolomide; in arm 2, patients will receive temozolomide with placebo.
The primary outcome is overall survival. Secondary outcomes include progression-free survival and frequency/variety of adverse events.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/study/NCT02546102.
Status: This study is open and recruiting patients as of February 24, 2017.
This study is sponsored by ImmunoCellular Therapeutics, Ltd in collaboration with Novella Clinical. Phase 1 trial data about the efficacy of ICT-107 can be found in an article published in Cancer Immunology, Immunotherapy.2
- Clinicaltrials.gov. 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. NCT02546102. https://clinicaltrials.gov/ct2/show/study/NCT02546102. Accessed February 24, 2017.
- Phuphanich S, Wheeler CJ, Rudnick JD, et al. Phase I trial of a multi-epitope-pulsed dendritic cell vaccine for patients with newly diagnosed glioblastoma. Cancer Immunol Immunother. 2013;62(1):125-35. doi: 10.1007/s00262-012-1319-0