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

Primary Purpose

Severe Sepsis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nivolumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Severe Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uc Davis Medical Center
  • Univ. Of Colorado Health
  • Denver Health Medical Center
  • University Of Florida
  • Pulmonary And Critical Care Of Atlanta
  • Osf Saint Francis Medical Center
  • University Of Kentucky
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center (BIDMC)
  • Baystate Medical Center
  • University of Michigan, Division of Acute Care Surgery
  • Washington University School Of Medicine
  • Duke University Medical Center
  • The Ohio State University
  • UPMC
  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nivolumab 1

Nivolumab 2

Arm Description

Dose 1

Dose 2

Outcomes

Primary Outcome Measures

Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths
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.
Peak Nivolumab Serum Concentration (Cmax)
Participants peak nivolumab serum concentration
Trough Nivolumab Serum Concentration (Cmin)
Participant trough nivolumab serum concentration
Average Nivolumab Serum Concentration (Cavg)
Participant average nivolumab serum concentration
Time of Maximum Observed Concentration (Tmax)
Participant observed time of maximum concentration
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
Total Clearance (CLT)
Total clearance of serum concentration of nivolumab
Volume of Distribution (Vd)
Vlume of distribution of nivolumab serum concentration
Half-life (T1/2)
Half-Life of nivolumab derived from serum concentration

Secondary Outcome Measures

Receptor Occupancy
Receptor occupancy on T cells at baseline and after study treatment administration at planned sampling time points
Number of Participants With Detectable Anti-nivolumab Antibodies
Participant with positive anti-drug antibody detection
Number of Participants With Any Detectable Anti-drug Antibodies

Full Information

First Posted
November 8, 2016
Last Updated
April 19, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02960854
Brief Title
A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 7, 2016 (Actual)
Primary Completion Date
January 5, 2018 (Actual)
Study Completion Date
January 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab 1
Arm Type
Experimental
Arm Description
Dose 1
Arm Title
Nivolumab 2
Arm Type
Experimental
Arm Description
Dose 2
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
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
Title
Composite of Vital Signs and Electrocardiogram (ECG)
Description
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)
Title
Peak Nivolumab Serum Concentration (Cmax)
Description
Participants peak nivolumab serum concentration
Time Frame
Day 1 and subsequent days after, up to 90 days
Title
Trough Nivolumab Serum Concentration (Cmin)
Description
Participant trough nivolumab serum concentration
Time Frame
Day 1 and subsequent days after, up to 90 days
Title
Average Nivolumab Serum Concentration (Cavg)
Description
Participant average nivolumab serum concentration
Time Frame
Day 1 and subsequent days after, up to 90 days
Title
Time of Maximum Observed Concentration (Tmax)
Description
Participant observed time of maximum concentration
Time Frame
Day 1 and subsequent days after, up to 90 days
Title
Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
Description
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
Title
Total Clearance (CLT)
Description
Total clearance of serum concentration of nivolumab
Time Frame
Day 1 and subsequent days after, up to 90 days
Title
Volume of Distribution (Vd)
Description
Vlume of distribution of nivolumab serum concentration
Time Frame
Day 1 and subsequent days after, up to 90 days
Title
Half-life (T1/2)
Description
Half-Life of nivolumab derived from serum concentration
Time Frame
Day 1 and subsequent days after, up to 90 days
Secondary Outcome Measure Information:
Title
Receptor Occupancy
Description
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)
Title
Number of Participants With Detectable Anti-nivolumab Antibodies
Description
Participant with positive anti-drug antibody detection
Time Frame
Baseline and subsequent days after, up to 90 days
Title
Number of Participants With Any Detectable Anti-drug Antibodies
Time Frame
Baseline and subsequent days after, up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Uc Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Univ. Of Colorado Health
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
University Of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Pulmonary And Critical Care Of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Osf Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
University Of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (BIDMC)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Michigan, Division of Acute Care Surgery
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5008
Country
United States
Facility Name
Washington University School Of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261-2500
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31576433
Citation
Hotchkiss RS, Colston E, Yende S, Crouser ED, Martin GS, Albertson T, Bartz RR, Brakenridge SC, Delano MJ, Park PK, Donnino MW, Tidswell M, Mayr FB, Angus DC, Coopersmith CM, Moldawer LL, Catlett IM, Girgis IG, Ye J, Grasela DM. Immune checkpoint inhibition in sepsis: a Phase 1b randomized study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of nivolumab. Intensive Care Med. 2019 Oct;45(10):1360-1371. doi: 10.1007/s00134-019-05704-z. Epub 2019 Oct 1.
Results Reference
derived
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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