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

Severe Sepsis Clinical Trial

Official title:

Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936558 (Nivolumab) in Participants With Severe Sepsis or Septic Shock.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960854
• Other study ID #: CA209-923
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2016
• Est. completion date: January 5, 2018

Study information

• Verified date: April 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 5, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Shock, Septic
• Toxemia

Intervention

Biological:
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
United States	University of Michigan, Division of Acute Care Surgery	Ann Arbor	Michigan
United States	Pulmonary And Critical Care Of Atlanta	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Univ. Of Colorado Health	Colorado Springs	Colorado
United States	The Ohio State University	Columbus	Ohio
United States	Denver Health Medical Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	University Of Florida	Gainesville	Florida
United States	University Of Kentucky	Lexington	Kentucky
United States	Osf Saint Francis Medical Center	Peoria	Illinois
United States	UPMC	Pittsburgh	Pennsylvania
United States	Uc Davis Medical Center	Sacramento	California
United States	Washington University School Of Medicine	Saint Louis	Missouri
United States	Harborview Medical Center	Seattle	Washington
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	Screening up to 90 days (Discharge)
Primary	Peak Nivolumab Serum Concentration (Cmax)	Participants peak nivolumab serum concentration	Day 1 and subsequent days after, up to 90 days
Primary	Trough Nivolumab Serum Concentration (Cmin)	Participant trough nivolumab serum concentration	Day 1 and subsequent days after, up to 90 days
Primary	Average Nivolumab Serum Concentration (Cavg)	Participant average nivolumab serum concentration	Day 1 and subsequent days after, up to 90 days
Primary	Time of Maximum Observed Concentration (Tmax)	Participant observed time of maximum concentration	Day 1 and subsequent days after, up to 90 days
Primary	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	Day 1 and subsequent days after, up to 90 days
Primary	Total Clearance (CLT)	Total clearance of serum concentration of nivolumab	Day 1 and subsequent days after, up to 90 days
Primary	Volume of Distribution (Vd)	Vlume of distribution of nivolumab serum concentration	Day 1 and subsequent days after, up to 90 days
Primary	Half-life (T1/2)	Half-Life of nivolumab derived from serum concentration	Day 1 and subsequent days after, up to 90 days
Secondary	Receptor Occupancy	Receptor occupancy on T cells at baseline and after study treatment administration at planned sampling time points	Day 1 and up to day 90 (discharge)
Secondary	Number of Participants With Detectable Anti-nivolumab Antibodies	Participant with positive anti-drug antibody detection	Baseline and subsequent days after, up to 90 days
Secondary	Number of Participants With Any Detectable Anti-drug Antibodies		Baseline and subsequent days after, up to 90 days

External Links

•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form