A Phase II Study of MEDI4736 in Patients with Glioblastoma

Full Title

A Phase 2 Study to Evaluate the Clinical Efficacy and Safety of MEDI4736 in Patients with Glioblastoma (GBM)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug MEDI4736 in patients with glioblastoma. MEDI4736 is an antibody designed to boost the body’s immune system by targeting a protein on tumor cells called PD-L1.

PD-L1 normally maintains the balance of the immune system. In cancer, PD-L1 helps tumors escape detection and destruction by the immune system. MEDI4736 may increase the immune system’s ability to identify and destroy cancer cells. It is given intravenously (by vein).

This clinical trial will enroll three separate groups of patients:

  • Those with previously untreated glioblastoma will receive MEDI4736 in combination with radiation therapy.
  • Patients whose glioblastoma came back after treatment with bevacizumab will receive MEDI4736 plus bevacizumab.
  • Those whose glioblastoma came back and who never had bevacizumab will receive MEDI4736 alone.

Eligibility

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

  • Patients must have either previously untreated (newly diagnosed) glioblastoma or recurrent glioblastoma.
  • Patients may not have had prior therapies that targeted PD-1 or PD-L1.
  • 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. Thomas Kaley at 212-639-5122 or the Brain Tumor Hotline at 212-639-6767.

Protocol

14-258

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators