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

Phase 1

Completed

• Conditions: Severe Sepsis
• Interventions: Biological: Nivolumab

• 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

Study Timeline

• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-10
• Study Start: 2016-12-07
• Primary Completion: 2018-01-05
• Study Completion: 2018-01-05
• Results First Submitted: 2019-01-05
• Results First Submitted QC: 2019-01-05
• Status Verified: 2019-04
• Results First Posted: 2019-04-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nivolumab 1	Nivolumab	Dose 1
Nivolumab 2	Nivolumab	Dose 2

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 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
Number of Participants With Any Detectable Anti-drug Antibodies	Baseline and subsequent days after, up to 90 days

Trial Locations

Locations (16)

Univ. Of Colorado Health; 🇺🇸 Colorado Springs, Colorado, United States

Pulmonary And Critical Care Of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Osf Saint Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

Washington University School Of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University Of Florida; 🇺🇸 Gainesville, Florida, United States

University Of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Beth Israel Deaconess Medical Center (BIDMC); 🇺🇸 Boston, Massachusetts, United States

Uc Davis Medical Center; 🇺🇸 Sacramento, California, United States

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Michigan, Division of Acute Care Surgery; 🇺🇸 Ann Arbor, Michigan, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States