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An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma

 

Summary

This phase III, randomized, double-blinded, placebo-controlled clinical trial evaluates the efficacy of nivolumab (an immunotherapy drug) in combination with temozolomide (TMZ; a common chemotherapy drug) and radiation therapy, for treating patients with newly diagnosed glioblastoma. Patients must have glioblastoma that is MGMT-methylated, a specific molecular feature used to further characterize tumor types, to be eligible.

Nivolumab is an antibody-based immunotherapy that helps energize a patient’s immune system against tumor cells. It’s been approved for use in several cancers, and is currently being investigated for glioblastoma.

Nivolumab is designed to block the activity of PD-1, a protein that normally protects the body from attacking itself. PD-1 prevents immune cells from attacking by detecting a molecular signal (called PD-L1) made by various cells across the body. Some cancer cells take advantage of this protection mechanism making the protective signal themselves. Nivolumab directly binds PD-L1, thus blocking the activity of PD-1. This allows the immune system to activate its T-cells and recognize the tumor as cells to be attacked.

Chemotherapy drugs, like TMZ, work in different ways to stop tumor growth, either by killing the cells or stopping them from dividing. Using a combination of immunotherapy and chemotherapy drugs may be effective in attacking tumor cells via multiple mechanisms. Specifically, this phase III trial will compare the effects of the following two groups:

  • Experimental Group: Nivolumab + TMZ + radiation therapy
  • Placebo Comparator: Placebo + TMZ + radiation therapy

 

Inclusion Criteria
  1. Males and females, age ≥ 18 years old
  2. Newly diagnosed glioblastoma (GBM)
  3. Karnofsky performance status of ≥ 70 (able to take care of self)
  4. Substantial recovery from surgery resection
  5. Tumor test result shows MGMT methylated or indeterminate tumor subtype

For a full description of criteria, please visit clinicaltrials.gov.

Exclusion Criteria
  1. Biopsy-only of GBM with less than 20% of tumor removed
  2. Prior treatment for GBM (other than surgical resection)
  3. Any known tumor outside of the brain
  4. Recurrent or secondary GBM
  5. Active known or suspected autoimmune disease

For a full description of criteria, please visit clinicaltrials.gov.

Investigator(s)

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