A Longitudinal Assessment of Tumor Evolution in Patients with Brain Cancer

Patients having a clinically planned surgical procedure (biopsy or cytoreduction) for a suspected diagnosis of glioblastoma will be approached for participation in this study. Tumor tissue obtained from surgery will be used for histological diagnosis and clinical molecular profiling, and excess tumor tissue will be collected for potential correlative studies. A small sample of blood and CSF for research will also be collected.
Once a diagnosis of glioblastoma is confirmed, the patient will be randomized 1:1:1 to Treatment Arm 1 standard of care (radiation + chemotherapy), Treatment Arm 2 (nivolumab), or Treatment Arm 3 (nivolumab + ipilimumab). Treatment will be started approximately 7-42 days following surgery once the patient has recovered from surgery. Routine clinical evaluations will be performed prior to treatment initiation and throughout treatment as clinically indicated. Radiographic brain imaging will be performed approximately 21-42 after treatment initiation and then routinely for medical management. Tumor response will be assessed according to immunotherapy Response Assessment in Neuro-Oncology (iRANO) Working Group criteria.
Treatment may continue until the patient experiences unacceptable toxicity or clear disease progression. The determination of whether to stop treatment due to disease progression will be based on the investigator’s evaluation of the patient’s clinical and radiographic condition, taking into consideration the interpretation of localized inflammatory responses that can mimic radiographic features of tumor progress. Patients discontinuing treatment will be directed by their treating physician for the next step in their medical management – such as a clinically-indicated cytoreductive surgery, standard radiation chemotherapy if assigned to study arm 2 or 3, or a different treatment regimen. If another treatment is started, clinical evaluations and response assessments will continue as clinically-indicated; blood and CSF will be collected after the first month, then every three to six months.

Participate in a Clinical Trial

Learn More