A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.

Phase 1

Completed

Conditions: Severe Sepsis

Registration Number: NCT02960854

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in participants with severe sepsis or septic shock.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

Inclusion Criteria

Men and women ages ≥ 18 years old
Documented or suspected infection
Severe sepsis or septic shock for at least 24 hours
Sepsis-induced immunosuppression
In Intensive Care Unit (ICU) with no plans to discharge in next 24 hours

Exclusion Criteria

Previous episode of severe sepsis or septic shock with ICU admission during the current hospitalization
Autoimmune disease
Organ or bone marrow transplant
Cancer treatment in the past 6 weeks
Human immunodeficiency virus (HIV) infection and not on therapy prior to this episode of sepsis; hepatitis C virus(HCV) infection and still has virus (not cured); Chronic hepatitis B virus (HBV) infection and not on treatment

Other protocol defined inclusion/exclusion criteria could apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths	Screening, day -1, day 1 and subsequent days after, up to 90 days
Composite of Vital Signs and Electrocardiogram (ECG)	Screening up to 90 days (Discharge)	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.
Peak Nivolumab Serum Concentration (Cmax)	Day 1 and subsequent days after, up to 90 days	Participants peak nivolumab serum concentration
Trough Nivolumab Serum Concentration (Cmin)	Day 1 and subsequent days after, up to 90 days	Participant trough nivolumab serum concentration
Time of Maximum Observed Concentration (Tmax)	Day 1 and subsequent days after, up to 90 days	Participant observed time of maximum concentration
Average Nivolumab Serum Concentration (Cavg)	Day 1 and subsequent days after, up to 90 days	Participant average nivolumab serum concentration
Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]	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
Total Clearance (CLT)	Day 1 and subsequent days after, up to 90 days	Total clearance of serum concentration of nivolumab
Volume of Distribution (Vd)	Day 1 and subsequent days after, up to 90 days	Vlume of distribution of nivolumab serum concentration
Half-life (T1/2)	Day 1 and subsequent days after, up to 90 days	Half-Life of nivolumab derived from serum concentration

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Any Detectable Anti-drug Antibodies	Baseline and subsequent days after, up to 90 days
Number of Participants With Detectable Anti-nivolumab Antibodies	Baseline and subsequent days after, up to 90 days	Participant with positive anti-drug antibody detection
Receptor Occupancy	Day 1 and up to day 90 (discharge)	Receptor occupancy on T cells at baseline and after study treatment administration at planned sampling time points

Trial Locations

Locations (16): Uc Davis Medical Center
🇺🇸
Sacramento, California, United States
Univ. Of Colorado Health
🇺🇸
Colorado Springs, Colorado, United States
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
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Uc Davis Medical Center
🇺🇸Sacramento, California, United States