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 the drugs nivolumab and ipilimumab in patients with glioblastoma that has returned despite temozolomide and radiation therapy.
Nivolumab is an investigational drug that 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 is approved for treating melanoma. Studies of the combination of ipilimumab and nivolumab have also demonstrated their effectiveness against melanoma and other types of cancer.
Patients in this study will be randomly assigned to receive nivolumab alone, or nivolumab plus ipilimumab. Both drugs are given intravenously (by vein). There is no placebo given in this study.