The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

Many people with malignant brain tumors will have their tumors come back after standard therapy. This is called a recurrence. There is no standard accepted therapy for these tumors once they have come back. Nivolumab is a drug that stimulates the immune system. Another experimental drug, BMS-986016 also works on the immune system. The safety and the effect of this drug combination on the immune system in the brain and on brain tumors is unknown.

The purpose of this study (18-N-0077) is to explore the effects of nivolumab on the brain’s immune system in people who have a recurrence of glioblastoma brain tumors. The study also will look at the safety and effects of nivolumab and BMS-986016 on the brain tumor. We will also evaluate the safety of experimental microdialysis catheters. These are thin tubes placed in the brain temporarily to monitor brain immune function

Ten participants will enroll in this study and be screened with a physical examination; a review of their medical history; a neurological exam; questions about their symptoms and quality of life; and a blood draw. Participants also may have magnetic resonance imaging (MRI) or computed tomography (CT) scans.

Eligible participants will be hospitalized for 2 weeks and will have 2 surgeries. During the first surgery, which is for research purposes only, the study team will take a tissue sample of the tumor and insert small tubes called microdialysis catheters into the brain to collect brain fluids and molecules.  Two days after the first surgery, participants will receive a single dose of nivolumab. The second surgery will occur one week later during which the study team will remove as much of the tumor as possible as well as the microdialysis catheters. All surgical procedures will be done while participants are under general anesthesia. After the second surgery, participants will be given nivolumab and BMS-986016 every 2 weeks and monitored for recurrence of the tumor or any side effects.

After leaving the hospital, participants will have outpatient visits lasting about 5 hours every other week until there are signs that the tumor has returned.

Knowledge gained from this research may lead to future advances in the treatment of recurrent malignant brain tumors.

Travel assistance may be provided within the U.S.

All research related care and experimental treatment provided at no cost.

Eligibility Criteria:

Inclusion

You may be eligible for this study if you:

  • Are 18 years of age or older
  • Have a recurrent glioblastoma that can be safely taken out.
  • Are willing to undergo surgery for this lesion.
  • Are eligible for and willing to consent for our “Evaluation and Treatment of Neurosurgical Disorders” protocol
  • Are willing to use an effective method of contraception during the clinical study

Exclusion

You may not be eligible for this research study if you:

  • Have a bleeding disorder
  • Are pregnant or breastfeeding
  • Have metal in your body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if you were a welder or metal worker, since you may small metal fragments in the eye.
  • Are uncomfortable in small closed spaces (you have claustrophobia) so that you would feel uncomfortable in the MRI machine.
  • Are not able to lie comfortably on your back for up to 60 minutes
  • Have an immune system that is not working
  • Have a history of organ or tissue transplants
  • Are currently undergoing treatment with another therapeutic agent

Study Design:

Interventional, Pharmacodynamics

Study Location:

Maryland