Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02960854
Recruitment Status : Completed
First Posted : November 10, 2016
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Severe Sepsis Biological: Nivolumab Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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.
Actual Study Start Date : December 7, 2016
Actual Primary Completion Date : January 5, 2018
Actual Study Completion Date : January 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab 1
Dose 1
Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558

Experimental: Nivolumab 2
Dose 2
Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558




Primary Outcome Measures :
  1. Composite 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 ]
  2. Composite of vital signs, electrocardiogram (ECG), and clinical laboratory abnormalities [ Time Frame: Screening, day -1, day 1 and subsequent days after, up to 90 days ]
  3. Peak nivolumab serum concentration (Cmax) [ Time Frame: Day 1 and subsequent days after, up to 90 days ]
  4. Trough nivolumab serum concentration (Cmin) [ Time Frame: Day 1 and subsequent days after, up to 90 days ]
  5. Average nivolumab serum concentration (Cavg) [ Time Frame: Day 1 and subsequent days after, up to 90 days ]
  6. Time of maximum observed concentration (Tmax) [ Time Frame: Day 1 and subsequent days after, up to 90 days ]
  7. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Day 1 and subsequent days after, up to 90 days ]
  8. Total clearance (CLT) [ Time Frame: Day 1 and subsequent days after, up to 90 days ]
  9. Volume of distribution (Vd) [ Time Frame: Day 1 and subsequent days after, up to 90 days ]
  10. Half-life (T1/2) [ Time Frame: Day 1 and subsequent days after, up to 90 days ]

Secondary Outcome Measures :
  1. Receptor occupancy [ Time Frame: Day 1 and subsequent days after, up to 90 days ]
  2. Number of participants with detectable anti-nivolumab antibodies [ Time Frame: Baseline and subsequent days after, up to 90 days ]
  3. Number of participants with any detectable anti-drug antibodies [ Time Frame: Baseline and subsequent days after, up to 90 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960854


Locations
Layout table for location information
United States, California
Uc Davis Medical Center
Sacramento, California, United States, 95817
United States, Colorado
Univ. Of Colorado Health
Colorado Springs, Colorado, United States, 80909
Denver Health Medical Center
Denver, Colorado, United States, 80204
United States, Florida
University Of Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Pulmonary And Critical Care Of Atlanta
Atlanta, Georgia, United States, 30303
United States, Illinois
Osf Saint Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Kentucky
University Of Kentucky
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States, 02215
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
University of Michigan, Division of Acute Care Surgery
Ann Arbor, Michigan, United States, 48109-5008
United States, Missouri
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15261-2500
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02960854     History of Changes
Other Study ID Numbers: CA209-923
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents