A Phase Ia/b Study of FPA008 plus Nivolumab Immunotherapy to Treat Persistent Glioblastoma

Full Title

A Phase 1a/b Study of FPA008 in Combination with Nivolumab in Patients with Selected Advanced Cancers

Purpose

The purpose of this study is to assess the safety of the combination of two immunotherapy drugs against glioblastoma that has continued to grow despite standard therapy. The two drugs are FPA008 and nivolumab.

FPA008 is an antibody designed to trigger an immune response against cancer by binding to a protein on cancer cells called CSF1R. It is an investigational drug. Nivolumab enhances the immune system's ability to detect and destroy cancer cells by blocking a protein on white blood cells called PD-1. Nivolumab is approved to treat a variety of cancers; its use against glioblastoma is considered investigational.

Both FPA008 and nivolumab 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 continued to grow despite standard therapy.
  • At least 2 weeks must pass between the completion of prior treatments and entry into the study.
  • 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 about this study and to inquire about eligibility, please contact Dr. Mariza Daras at 212-610-0239.

Protocol

16-753

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators