A Phase IIB Study of Nivolumab Alone or with Ipilimumab in Patients with Recurrent Glioblastoma

Protocol
14-009
Full Title
A Randomized Phase IIb Open Label Study of Nivolumab or Nivolumab in Combination with Ipilimumab versus Bevacizumab in Adult Subjects with Recurrent Glioblastoma (GBM)
Phase
II
Disease Status
Relapsed/Refractory
Purpose

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.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have grade IV glioblastoma that has returned despite initial treatment which included temozolomide and radiation therapy.
  • Patients must be experiencing a first recurrence of their 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.

Disease(s)
Brain Tumors, Primary: Gliomas
Locations
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