Skip to main content
OpenTrials
Completed

NCT Number: NCT02960854

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Uc Davis Medical Center, Sacramento, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

Specified dose on specified days

Other names: BMS-936558

Primary outcomes

  1. 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

  2. Composite of Vital Signs and Electrocardiogram (ECG)

    Time frame: Screening up to 90 days (Discharge)

    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.

  3. Peak Nivolumab Serum Concentration (Cmax)

    Time frame: Day 1 and subsequent days after, up to 90 days

    Participants peak nivolumab serum concentration

  4. Trough Nivolumab Serum Concentration (Cmin)

    Time frame: Day 1 and subsequent days after, up to 90 days

    Participant trough nivolumab serum concentration

  5. Average Nivolumab Serum Concentration (Cavg)

    Time frame: Day 1 and subsequent days after, up to 90 days

    Participant average nivolumab serum concentration

  6. Time of Maximum Observed Concentration (Tmax)

    Time frame: Day 1 and subsequent days after, up to 90 days

    Participant observed time of maximum concentration

  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

    Area under the serum concentration-time curve from time zero to time of last quantifiable concentration

  8. Total Clearance (CLT)

    Time frame: Day 1 and subsequent days after, up to 90 days

    Total clearance of serum concentration of nivolumab

  9. Volume of Distribution (Vd)

    Time frame: Day 1 and subsequent days after, up to 90 days

    Vlume of distribution of nivolumab serum concentration

  10. Half-life (T1/2)

    Time frame: Day 1 and subsequent days after, up to 90 days

    Half-Life of nivolumab derived from serum concentration

Secondary outcomes

  1. Receptor Occupancy

    Time frame: Day 1 and up to day 90 (discharge)

    Receptor occupancy on T cells at baseline and after study treatment administration at planned sampling time points

  2. Number of Participants With Detectable Anti-nivolumab Antibodies

    Time frame: Baseline and subsequent days after, up to 90 days

    Participant with positive anti-drug antibody detection

  3. Number of Participants With Any Detectable Anti-drug Antibodies

    Time frame: Baseline and subsequent days after, up to 90 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 10, 2016
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.