Increasing Patient Access
Phase 2b Clinical Trial, IGV-001, for Patients with Newly Diagnosed Brain Cancer/Glioblastoma (ndGBM)
Today, the End Brain Cancer Initiative (EBCI) and I want to make you aware of an ongoing-clinical trial for newly diagnosed (initial diagnosis) patients with GBM (ndGBM). This trial is for patients aged 18 to 70 years old that are newly diagnosed and BEFORE they have resection/surgery to remove the tumor and before they start Standard of Care (SOC) radiation/chemo/treatment. To learn more, fill out our “IMVAX Trial Interest Form” so that our Clinical Trial Coordinator/Patient Navigator, can reach directly back out to you to give you more info and/or “Directly Connect” you to this trial’s sponsor and/or the Principal Investigator for this trial.
The trial is a randomized, multicenter, double-blind, placebo-controlled Phase 2b study designed to assess the safety and efficacy of IGV-001, an autologous biologic-device combination product, in ndGBM patients. The trial is expected to enroll up to 93 participants in a 2:1 randomization across approximately 25 sites in the United States. After surgical resection, participants in the IGV-001 arm will be implanted with biodiffusion chambers containing a combination of personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001); in the placebo arm, the chambers will contain an inactive solution only. In both arms, the biodiffusion chambers will be explanted approximately 48 hours later, and after six weeks all patients will be treated with standard of care (adjuvant radiotherapy and temozolomide followed by maintenance temozolomide.
The primary endpoint of the trial is progression-free survival and key secondary endpoints include overall survival and safety.
To learn more, the full patient inclusion/exclusion criteria for this trial can be found at www.clinicaltrials.gov, NCT04485949, and general information on Imvax and IGV-001 can be found at the End Brain Cancer website and the Imvax website.
Dellann Elliott Mydland
Board Chair, President & CEO
The EndBrainCancer Initiative | Chris Elliott Fund
16150 NE 85th St #201
Redmond WA 98052
