University of North Carolina (UNC) Health is enrolling patients as part of a multicenter clinical trial for patients who have been newly diagnosed with glioblastoma (GBM). The Phase 2b clinical study administers IGV-001, a combination immunotherapy developed by the biotech company, Imvax, Inc. UNC Health is one of multiple academic healthcare systems participating in the randomized trial that aims to enroll 93 patients with newly diagnosed brain tumors.
GBM is the most common and aggressive primary brain tumor. Despite the aggressive nature of these tumors, the standard of care has remained unchanged since 2005. UNC Health has a robust brain tumor research program and is currently conducting multiple clinical trials for GBM patients.
The purpose of the study is to assess the safety and efficacy of combination immunotherapy for newly diagnosed glioblastoma patients. The multicenter trial is a randomized, double-blind, placebo-controlled Phase 2b study. After surgical resection of the tumor at UNC Health, participants in the trial will be implanted for approximately 48 hours with small biodiffusion chambers containing either IGV-001—which is designed to induce a broad and durable immune response against tumors—or placebo. Six weeks after treatment, all patients will then proceed with standard-of-care treatment, adjuvant chemotherapy, and radiotherapy.
“UNC Health is the only site for this unique trial in North Carolina and in the South, making it a unique treatment option for newly diagnosed GBM patients,” said Soma Sengupta, MD, MBA, PhD, vice chair of the Department of Neurology and the principal investigator of the study at UNC Health.
In addition to UNC Health’s main campus in Chapel Hill, UNC Health will add 14 satellite sites within the state of North Carolina to allow patients who do not live close to the centrally located Chapel Hill to be assessed and potentially enrolled in the study.
- This press release was originally published on the UNC Health and UNC School of Medicine website