A Phase I Study of Immunotherapy with Anti-LAG-3 or Anti-CD137 Given Alone and with Nivolumab in Patients with Recurrent Glioblastoma Multiforme

Full Title

A Phase I Trial of Anti-LAG-3 or Anti-CD137 Alone and in Combination with Anti-PD-1 in Patients with Recurrent GBM (ABTC 1501)

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy drugs anti-LAG-3 and anti-CD137 that can be given in patients with recurrent glioblastoma multiforme (brain cancer) when each is given alone or in combination with the drug nivolumab. Anti-LAG-3 and anti-CD137 target molecules that block the immune response, thereby boosting the immune system's ability to find and kill cancer cells.

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 anti-LAG-3 or anti-CD137. Some patients will also receive nivolumab. All of these drugs 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 glioblastoma that has come back despite prior treatment that included radiation therapy and temozolomide.
  • Patients must be experiencing their first recurrence.
  • 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

16-374

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators