A Phase II Study of Nivolumab plus Radiation Therapy and Bevacizumab for Recurrent Glioblastoma

Full Title

A Phase II Trial of the PD-1 Antibody Nivolumab in Combination with Hypofractionated Re-irradiation and Bevacizumab for Recurrent MGMT Methylated Glioblastoma

Purpose

Additional radiation therapy (“re-radiation therapy”) and bevacizumab are treatments used for people with recurrent glioblastoma (GBM). In this study, researchers want to see if adding nivolumab immunotherapy to re-radiation is safe and enhances treatment effectiveness for patients with recurrent GBM. Some of the patients enrolled in this study will also undergo additional cancer surgery.

Nivolumab targets 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 mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. By blocking PD-1, nivolumab enhances the body’s ability to detect and destroy cancer cells.

Bevacizumab is often used in combination with radiation therapy as a treatment for patients whose glioblastoma grows during or after initial therapy. In this study, nivolumab is being added to this combination to find out if this treatment is more effective than bevacizumab and/or radiation therapy.

Patients in this study will receive nivolumab, bevacizumab, and radiation therapy with or without surgery. Nivolumab and bevacizumab are 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 have grade IV MGMT-methylated glioblastoma that has grown despite one prior regimen of treatment with radiation therapy and temozolomide.
  • Patients may not have already received immunotherapy or bevacizumab.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Christian Grommes at 212-639-4058.

Protocol

18-400

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators