In an ongoing phase II trial, researchers are investigating several targeted agents for use in the treatment of patients with glioblastoma (GBM).
The study, known as the INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT; NCT02977780), will randomize patients to 1 of 4 arms—either the control arm of standard-of-care agent temozolomide (Temodar), or 1 of 3 experimental arms. The experimental arms are abemaciclib in combination with temozolomide, neratinib (Nerlynx) with temozolomide, and CC-115 alone. All 4 arms include daily radiation for a maximum of 49 days.
Temozolomide is FDA approved for the treatment of patients with GBM, while abemaciclib, neratinib, and CC-115 are all currently experimental in this landscape.
Primary outcomes of the study, which is currently accruing patients, are overall survival in the experimental arms compared with standard temozolomide, and secondary endpoints among the experimental arms include incidence of treatment-emergent adverse events, and progression-free survival.
Eligible patients must have evidence that their tumor MGMT promoter is unmethylated and must be immunohistochemically negative for IDH1 R132H mutations.
In an interview with OncLive, principal investigator Brian M. Alexander, MD, disease center leader, Radiation Oncology, Center for Neuro-Oncology, senior physician, associate professor of radiation oncology, Harvard Medical School, Dana-Farber Cancer Institute, discusses the significance of the INSIGhT trial in GBM.
Click HERE to read the interview.