This study is for patients 22 and older with a glioblastoma (a type of brain tumor) that has grown back (recurred) or not gotten better after being treated with bevacizumab. The purpose of this study is to test any good and bad effects of adding bevacizumab to a type of therapy for brain tumors called Optune. Optune is a portable device that produces electrical signals, called Tumor Treating Fields ("TTFields"). Optune is a portable device worn on the patients head that send wave-like electric signals directly to their tumor. The device will be worn continuously throughout the day for at least 18 hours a day with breaks allowed for personal needs.
You are invited to volunteer for a research study because you previously consented to participate in a companion study BMS 498, but did not meet eligibility criteria for MGMT status; therefore, you are newly diagnosed with glioblastoma and the tumor has a specific profile that is referred to as MGMT methylated.
This study will test the effectiveness, safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow your body's immune system to work against tumor cells.You will also receive standard radiation therapy in unison with temozolomide and the study drug treatment, nivolumab or placebo.
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells. The effectiveness of nivolumab in glioblastoma (GBM or brain cancer) will be determined by comparing the survival of subjects who receive the investigational drug nivolumab combined with radiotherapy to those who receive temozolomide with radiotherapy, an accepted therapy for newly diagnosed GBM.
If you agree to be in this study, a biopsy of your tumor will tested for a specific gene. If you have that gene, you will be eligible to participate in the study. In addition to taking either nivolumab or temozolomide in combination with radiotherapy you will be asked to complete other study procedures. Those study procedures may include physical exams, medical history, blood draws, MRI scans, questionnaires.
The main purpose of this study is to research the investigational drug (not yet approved by the Food and Drug Administration), ABT414. Human studies have shown ABT-414 can shrink EGFR (epidermal growth factor receptor)-amplified glioblastomas (GBM's) in some people whose tumors were growing despite earlier RT (radiation) and chemotherapy treatment. This investigational drug will be given at the same with radiation therapy and the FDA approved chemotherapy drug, temozolomide.
If the subject meets the study requirements and agrees to volunteer, they will be on the study for approximately 2 years, and will be asked to go to study visits every 2 weeks.
Approximately 720 subjects will be asked to take part, 8 of them will be at MUSC.