A Randomized Phase 3 Open Label Study of Nivolumab versus Bevacizumab and Multiple Phase 1 Safety Cohorts of Nivolumab or Nivolumab in Combination with Ipilimumab Across Different Lines of Glioblastoma
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test the safety and tolerability of an investigational drug called nivolumab (also known as BMS-936558 or Opdiva) in patients diagnosed with glioblastoma. 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 and is not approved for the treatment of glioblastoma. Nivolumab is not approved for commercial use by the U.S. Food and Drug Administration FDA). The FDA is allowing the use of nivolumab in this study. The purpose of Cohorts 1c and 1d Part B is to see if temozolomide (a chemotherapy agent) has any enhancing or limiting effect on nivolumab therapy.NOTE: Enrollment to Cohorts 1, 1b, 2 and to Part A of Cohorts 1c and 1d has been completed and patients continue to be monitored on an ongoing basis.
Subjects participating in Part B of Cohort 1c or 1d have been newly diagnosed with a glioblastoma whose tumor has a certain biomarker profile that is referred to as unmethylated 06-methylguanine-DNA methyltransferase (MGMT) status.
Depending on your assignment to Cohort 1c or 1d, you will receive surgical treatment and radiation therapy with (Cohort 1c) or without (Cohort 1d) the chemotherapy agent temozolomide in addition to nivolumab (both Cohorts 1c and 1d) during the trial. Patients with unmethylated MGMT tumors appear to be less responsive to treatment with temozolomide.
06/26/2016 05:03 AM