A Pilot Study of Pembrolizumab Immunotherapy in Patients with Recurrent Glioblastoma Who Need Surgery

Full Title

A Phase Ib clinical trial to evaluate early immunologic pharmacodynamic parameters for the PD-1 checkpoint inhibitor, pembrolizumab (MK-3475), in patients with surgically accessible recurrent/progressive glioblastoma

Purpose

People with glioblastoma that comes back after initial therapy with radiation therapy and/or temozolomide sometimes have surgery followed by additional chemotherapy. In this study, researchers are evaluating the effectiveness of the immunotherapy drug pembrolizumab in patients with recurrent glioblastoma when given after surgery compared with treatment that begins before surgery.

Patients will be randomly assigned to one of two groups. One group will have pembrolizumab prior to surgery as well as every three weeks after surgery. The second group will have surgery followed by pembrolizumab every three weeks.

Pembrolizumab is a form of immunotherapy. It works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. Pembrolizumab is already approved to treat other cancers; its use in this study is considered investigational. It is 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 came back despite initial therapy that included radiation therapy.
  • Patients must recover from the serious side effects of previous therapies.
  • 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

16-1493

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators