A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in participants with severe sepsis or septic shock.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
38
Specified dose on specified days
Uc Davis Medical Center
Sacramento, California, United States
Univ. Of Colorado Health
Colorado Springs, Colorado, United States
Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths
Time frame: Screening, day -1, day 1 and subsequent days after, up to 90 days
Composite of Vital Signs and Electrocardiogram (ECG)
Includes body temperature, respiratory rate, blood pressure and heart rate. Blood pressure and heart rate should be measured after the participant has been resting quietly for at least 5 minutes.
Time frame: Screening up to 90 days (Discharge)
Peak Nivolumab Serum Concentration (Cmax)
Participants peak nivolumab serum concentration
Time frame: Day 1 and subsequent days after, up to 90 days
Trough Nivolumab Serum Concentration (Cmin)
Participant trough nivolumab serum concentration
Time frame: Day 1 and subsequent days after, up to 90 days
Average Nivolumab Serum Concentration (Cavg)
Participant average nivolumab serum concentration
Time frame: Day 1 and subsequent days after, up to 90 days
Time of Maximum Observed Concentration (Tmax)
Participant observed time of maximum concentration
Time frame: Day 1 and subsequent days after, up to 90 days
Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration
Time frame: Day 1 and subsequent days after, up to 90 days
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Denver Health Medical Center
Denver, Colorado, United States
University Of Florida
Gainesville, Florida, United States
Pulmonary And Critical Care Of Atlanta
Atlanta, Georgia, United States
Osf Saint Francis Medical Center
Peoria, Illinois, United States
University Of Kentucky
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
...and 6 more locations
Total Clearance (CLT)
Total clearance of serum concentration of nivolumab
Time frame: Day 1 and subsequent days after, up to 90 days
Volume of Distribution (Vd)
Vlume of distribution of nivolumab serum concentration
Time frame: Day 1 and subsequent days after, up to 90 days
Half-life (T1/2)
Half-Life of nivolumab derived from serum concentration
Time frame: Day 1 and subsequent days after, up to 90 days
Receptor Occupancy
Receptor occupancy on T cells at baseline and after study treatment administration at planned sampling time points
Time frame: Day 1 and up to day 90 (discharge)
Number of Participants With Detectable Anti-nivolumab Antibodies
Participant with positive anti-drug antibody detection
Time frame: Baseline and subsequent days after, up to 90 days
Number of Participants With Any Detectable Anti-drug Antibodies
Time frame: Baseline and subsequent days after, up to 90 days