Newswise — CHAPEL HILL, N.C. – UNC Health is now 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 biotech company Imvax. UNC Health is one of multiple academic healthcare systems across the country participating in the randomized trial that aims to enroll 93 patients with newly diagnosed brain tumors.
“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. Patients will still come to UNC Hospitals in Chapel Hill, NC for weekly treatments, if they are enrolled in the study.
GBM is the most common and aggressive primary brain tumor. Patients diagnosed with GBM have a five-year survival rate of only 6.8%. Despite the aggressive nature of these tumors, the standard of care remains 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 a 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, at UNC Health.
As well as being division chief of the Division of Neuro-Oncology and member of Lineberger Comprehensive Cancer Center, Sengupta is a physician-scientist specializing in brain tumor treatment and research with over 90 publications on clinical trials, lab-based research, healthcare policy and case reports.
Dominique Higgins, MD, PhD, assistant professor of neurosurgery and member of Lineberger Comprehensive Cancer Center, and Carlos David, MD, professor of neurosurgery, both specializing in brain tumor treatment and members of the multidisciplinary neuro-oncology clinic at UNC Health, will be involved in the trial.
Higgins is a neurosurgical oncologist whose research and clinical focus is on the treatment of malignant brain tumors, including glioblastoma. David’s range of expertise includes all skull base and complex brain tumors and endoscopic skull base surgery.
Imvax, Inc. is a clinical-stage biotechnology company with a unique platform technology, Goldspire™, focused on delivering personalized, whole tumor-derived immunotherapies across a range of solid tumors. The primary endpoint of the trial is progression-free survival and key secondary endpoints include overall survival and safety in GBM patients. Prior Phase 1b results were promising and showed that IGV-001 was safe and well tolerated.
About UNC School of Medicine The UNC School of Medicine (SOM) is the state’s largest medical school, graduating more than 180 new physicians each year. It is consistently ranked among the top medical schools in the US, including 5th overall for primary care by US News & World Report, and 6th for research among public universities. More than half of the school’s 1,700 faculty members served as principal investigators on active research awards in 2021. Two UNC SOM faculty members have earned Nobel Prize awards.
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