A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.
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.
1 other identifier
interventional
38
1 country
16
Brief Summary
A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in participants with severe sepsis or septic shock.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2016
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2016
CompletedFirst Posted
Study publicly available on registry
November 10, 2016
CompletedStudy Start
First participant enrolled
December 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2018
CompletedResults Posted
Study results publicly available
April 4, 2019
CompletedApril 23, 2019
April 1, 2019
1.1 years
November 8, 2016
January 5, 2019
April 19, 2019
Conditions
Outcome Measures
Primary Outcomes (10)
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)
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)
Peak Nivolumab Serum Concentration (Cmax)
Participants peak nivolumab serum concentration
Day 1 and subsequent days after, up to 90 days
Trough Nivolumab Serum Concentration (Cmin)
Participant trough nivolumab serum concentration
Day 1 and subsequent days after, up to 90 days
Average Nivolumab Serum Concentration (Cavg)
Participant average nivolumab serum concentration
Day 1 and subsequent days after, up to 90 days
Time of Maximum Observed Concentration (Tmax)
Participant observed time of maximum concentration
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
Day 1 and subsequent days after, up to 90 days
Total Clearance (CLT)
Total clearance of serum concentration of nivolumab
Day 1 and subsequent days after, up to 90 days
Volume of Distribution (Vd)
Vlume of distribution of nivolumab serum concentration
Day 1 and subsequent days after, up to 90 days
Half-life (T1/2)
Half-Life of nivolumab derived from serum concentration
Day 1 and subsequent days after, up to 90 days
Secondary Outcomes (3)
Receptor Occupancy
Day 1 and up to day 90 (discharge)
Number of Participants With Detectable Anti-nivolumab Antibodies
Baseline and subsequent days after, up to 90 days
Number of Participants With Any Detectable Anti-drug Antibodies
Baseline and subsequent days after, up to 90 days
Study Arms (2)
Nivolumab 1
EXPERIMENTALDose 1
Nivolumab 2
EXPERIMENTALDose 2
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Uc Davis Medical Center
Sacramento, California, 95817, United States
Univ. Of Colorado Health
Colorado Springs, Colorado, 80909, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
University Of Florida
Gainesville, Florida, 32610, United States
Pulmonary And Critical Care Of Atlanta
Atlanta, Georgia, 30303, United States
Osf Saint Francis Medical Center
Peoria, Illinois, 61637, United States
University Of Kentucky
Lexington, Kentucky, 40536, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Michigan, Division of Acute Care Surgery
Ann Arbor, Michigan, 48109-5008, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Ohio State University
Columbus, Ohio, 43210, United States
UPMC
Pittsburgh, Pennsylvania, 15261-2500, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 31576433DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2016
First Posted
November 10, 2016
Study Start
December 7, 2016
Primary Completion
January 5, 2018
Study Completion
January 5, 2018
Last Updated
April 23, 2019
Results First Posted
April 4, 2019
Record last verified: 2019-04