CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Nivolumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03493932
NCT03493932Phase 1Completed

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

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Apr 11, 2018·Updated Jul 24, 2024

In Brief

A Phase 1 clinical trial evaluating Nivolumab and BMS-986016 for Glioblastoma. Completed, enrolled 21 participants across 2 sites.

Detailed Summary

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. ...

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedApr 11, 2018
Enrollment StartSep 24, 2018
Primary CompletionApr 21, 2023
Study CompletionJun 27, 2023
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 8.2 years ago

Interventions

Nivolumabdrug

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-986016drug

Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb