Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade

Part of paid clinical trials in Atlanta, Georgia.

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Study ID: NCT03493932
Phase: PHASE1
Status: Completed

Conditions

Glioblastoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Nivolumab — DRUG
OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
BMS-986016 — DRUG
Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb

Study Details

Background: Glioblastoma (GBM) brain tumors almost always return after treatment. When that happens the tumor can never completely be removed by surgery, so most people also receive drugs. Researchers want to see if combining the drugs nivolumab and BMS-986016 may help. Objectives: To study how nivolumab affects the brain s immune system in people who have had glioblastoma brain tumors return. To study how nivolumab and BMS-986016 affect brain tumors. Eligibility: Adults age 18 and older who have had a return of GBM Design: Participants will be screened with: Medical history Physical exam Cheek swab Heart, blood and urine tests Chest x-ray Magnetic resonance imaging (MRI) brain scan. Participants will lie on a table that slides in and out of a cylinder in a strong magnetic field. A contrast agent will be injected in an arm vein. Participants will stay in the hospital. They will: Have surgery. A tube will be inserted into the back. Brain tumor and bone marrow samples will be taken. Tubes will be inserted into the brain. Have a computed tomography brain scan. Stay in Intensive Care (ICU) 7 days. Fluid from the brain and back will be collected every few hours. In the ICU, participants will get nivolumab by IV for 30 minutes. Have surgery to remove the tubes. Have standard surgery to remove as much of the GBM as possible. Bone marrow will be removed. After leaving the hospital, participants will have visits every 2 weeks to get the study drugs by IV and have physical exams and blood tests. Participants will have a brain MRI once a month. ...