A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.
NCT ID: NCT02960854
Last Updated: 2019-04-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2016-12-07
2018-01-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Nivolumab 1
Dose 1
Nivolumab
Specified dose on specified days
Nivolumab 2
Dose 2
Nivolumab
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Uc Davis Medical Center
Sacramento, California, United States
Univ. Of Colorado Health
Colorado Springs, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
University Of Florida
Gainesville, Florida, United States
Pulmonary And Critical Care Of Atlanta
Atlanta, Georgia, United States
Osf Saint Francis Medical Center
Peoria, Illinois, United States
University Of Kentucky
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Michigan, Division of Acute Care Surgery
Ann Arbor, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
UPMC
Pittsburgh, Pennsylvania, United States
Harborview Medical Center
Seattle, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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CA209-923
Identifier Type: -
Identifier Source: org_study_id
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