Full TitleA Randomized Phase III 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
Temozolomide and radiation therapy are standard treatments for a form of brain cancer called glioblastoma. Yet despite this combination of therapies, many patients experience continued growth of the tumor. In this study, researchers are assessing the safety and effectiveness of incorporating the drugs nivolumab and ipilimumab in the treatment of patients with glioblastoma.
Nivolumab boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this shut-down mechanism by activating PD-1, enabling them to escape attack by the body’s white blood cells. Nivolumab binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.
Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that an antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune response that may help the body to destroy cancer cells. Ipilimumab and nivolumab are approved for treating melanoma. Nivolumab is also used to treat non-small cell lung cancer and previously treated advanced renal cell cancer. Studies of the combination of ipilimumab and nivolumab have also demonstrated their effectiveness against melanoma and other types of cancer.
In the first part of this study, nivolumab and the combination of nivolumab and ipilimumab were investigated in patients whose glioblastoma had come back and were compared to bevacizumab, a standard treatment for this disease. We have finished enrolling patients in that part of the study. We are now investigating the addition of nivolumab to the initial standard treatment for glioblastoma.
Patients in this study will receive nivolumab in combination with radiation therapy and temozolomide. Depending on the molecular features of each patient’s tumor, nivolumab may be combined with radiation therapy alone. Nivolumab is given intravenously (by vein). This portion of the study is not randomized, and there is no placebo.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have grade IV glioblastoma.
- Patients must be planning to receive initial standard treatments for glioblastoma.
- This study is open to patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Antonio Omuro at 212-639-7523.