August 13 2021
NRG-BN010: A Safety Run-In and Phase II Study Evaluating the Efficacy, Safety, and Impact on the Tumor Microenvironment of the Combination of Tocilizumab, Atezolizumab, and Fractionated Stereotactic Radiotherapy in Recurrent Glioblastoma
The NRG Oncology clinical trial NRG-BN010 consists of two parts, a safety run-in and a phase II trial constructed to determine the efficacy, safety, and impact of a specific drug combination in people with recurrent glioblastoma. The safety run-in of the trial will ascertain the maximum-tolerated dose (MTD) of tocilizumab and atezolizumab in combination with stereotactic radiotherapy. The phase II portion of the trial will study the efficacy of the combination of the study drugs tocilizumab and atezolizumab in combination with stereotactic radiotherapy. Phase I of the NRG-BN010 trial is currently enrolling and is open to all National Cancer Institute National Clinical Trials Network (NCTN) sites for patient accrual.
“People who have glioblastoma that returns after standard frontline treatment typically only have a survival time of less than 1 year. There is also a severe lack of effective treatment options for this population ,” stated Stephen J. Bagley, MD, MSCE, of the Hospital of the University of Pennsylvania and the Principal Investigator of the NRG-BN010 trial. “NRG-BN010 was designed to explore alternative options that may prolong survival with tolerable side effects in patients with recurrent glioblastoma.”
Patients enrolled into the NRG-BN010 safety run-in will receive tocilizumab or a combination of tocilizumab and atezolizumab followed by fractionated stereotactic radiotherapy (FSRT) and lastly, they will take tocilizumab or a combination of atezolizumab and tocilizumab every 4 weeks for 2 years. The goal of the safety run-in is to determine which of three sequential dose levels is the MTD.
Patient enrolled into the phase II portion of NRG-BN010 will be stratified into groups based on if surgical resection is or is not clinically indicated. If surgical resection is not clinically indicated, patients will receive tocilizumab or a combination of tocilizumab and atezolizumab followed by fractionated stereotactic radiotherapy (FSRT), followed by tocilizumab or a combination of atezolizumab and tocilizumab every 4 weeks for up to 2 years. If surgical resection is clinically indicated, patients will be randomized to either Arm 1 or Arm 2 of the second group. Patients on Arm 1 will receive tocilizumab or a combination of tocilizumab and atezolizumab followed by FSRT, followed by surgical resection. Patients on Arm 2 will receive atezolizumab alone, followed by FSRT, followed by surgical resection. Patients on both surgical Arm 1 and surgical Arm 2 will resume tocilizumab or a combination of atezolizumab and tocilizumab postoperatively and will continue on this treatment every 4 weeks for up to 2 years. The phase II portion of the study will also be open to all NCTN sites; however, the surgical arms will be limited to participation from select sites.
Researchers will be assessing objective radiographic response rate, progression-free survival, overall survival, and adverse events from the treatment provided during this trial. They will also conduct correlative studies to determine how tocilizumab, atezolizumab, and FSRT affect the glioblastoma immune microenvironment.
Learn more about this trial on ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website.