A Phase II Study of Temozolomide and Radiation Therapy with Nivolumab Immunotherapy or a Placebo in Patients Newly Diagnosed with Glioblastoma

Full Title

A Randomized Phase 2 Single Blind Study of Temozolomide Plus Radiation Therapy Combined with Nivolumab or Placebo in Newly Diagnosed Adult Subjects with MGMT-Methylated (tumor O6-methylguanine DNA methyltransferase) Glioblastoma

Purpose

Temozolomide plus radiation therapy is a standard treatment for glioblastoma (brain cancer), but the cancer often comes back. In this study, researchers want to see if giving the immunotherapy drug nivolumab with radiation therapy and temozolomide is more effective than the standard treatment.

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. It is used to treat several types of cancer; its use in this study is considered investigational.

Patients will be randomly assigned to receive temozolomide and radiation either with nivolumab or with a placebo (inactive drug). Temozolomide is taken orally (by mouth), and nivolumab is given intravenously (by vein).

Eligibility

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

  • Patients must be newly diagnosed with glioblastoma with methylated MGMT. The "methylated" MGMT marker means the tumor is more likely to respond to temozolomide.
  • Patients may have had prior surgery for glioblastoma, but no other therapy.
  • This study is for 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.

Protocol

16-453

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators