Clinical Trial Investigating a Combo Therapy in Brain Cancer Now Enrolling Patients

The study authors plan to enroll 24 patients with glioblastoma, an aggressive brain tumor, to assess the efficacy an investigational drug plus Libtayo prior to surgery to remove the tumor.

Researchers at the University of Cincinnati Health in Ohio and Dana-Farber Cancer Institute in Boston are investigating the use of an investigational drug in combination with Libtayo (cemiplimab-rwlc) prior to surgery in patients with glioblastoma, an aggressive brain tumor, according to a press release.

As long as it is visible and doesn’t affect the portion of the brain that controls function, a brain tumor can be surgically treated. However, as the press release highlighted, tiny remnants of the cancerous tissue always remain.

As a result, most treatment regimens for glioblastoma consist of surgery, radiation and chemotherapy. However, as Dr. Mario Zuccarello cautioned, this treatment method isn’t all that effective.

“Unfortunately the end result, which is an inability to cure the patient, has remained,” Zuccarello, the John M. Tew MD endowed chair in Neurosurgical Oncology at the University of Cincinnati College of Medicine and director of the University of Cincinnati Health Brain Tumor Center, said in the release. “We try to prolong life as much as possible, but the quality of life is a big problem, because these patients are not only subjected to surgical procedures, and sometimes repeated surgical procedures, but also chemotherapy and radiation.”

Providers from the University of Cincinnati Health and Dana-Farber Cancer Institute are collaborating on a phase 1 trial investigating the appropriate dosing levels and effect of Libtayo combined with the investigational drug ASP8374 both in patients whose disease has recurred after initial treatment as well as those who have not yet received surgery.

Enrolled patients must be at least 18 years old, have grade 4 disease (patients with grade 3 recurrent disease will only be enrolled onto the first portion of the trial), have previously received at least radiotherapy and be at their first or second relapse. Of note, the study authors have defined a relapse as the progression of disease following an initial therapy of radiation with or without chemotherapy. In patients who received therapy for a low-grade glioma, a diagnosis of a high-grade glioma during surgery will be considered the first relapse.

Dr. Soma Sengupta, the study’s principal investigator at the University of Cincinnati, noted that previous research has shown that single-agent immunotherapy has failed at treating this patient population and, as a result, led the research team to want to assess a combination therapy.

“There are many questions which are not answered, and we hope that we may be part of something big,” Zuccarello said in the release.

The study authors plan to enroll 24 patients with an estimated study completion date of December 2022.

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