CompletedPhase 1

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

United States38 participantsStarted 2016-12-07

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths

Timeframe: Screening, day -1, day 1 and subsequent days after, up to 90 days

Composite of Vital Signs and Electrocardiogram (ECG)

Timeframe: Screening up to 90 days (Discharge)

Peak Nivolumab Serum Concentration (Cmax)

Timeframe: Day 1 and subsequent days after, up to 90 days

Trough Nivolumab Serum Concentration (Cmin)

Timeframe: Day 1 and subsequent days after, up to 90 days

Average Nivolumab Serum Concentration (Cavg)

Timeframe: Day 1 and subsequent days after, up to 90 days

Time of Maximum Observed Concentration (Tmax)

Timeframe: 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)]

Timeframe: Day 1 and subsequent days after, up to 90 days

Trial details

NCT IDNCT02960854

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-01-05

Results submitted2019-01-05

View on ClinicalTrials.gov More Severe Sepsis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths

Timeframe: Screening, day -1, day 1 and subsequent days after, up to 90 days

Composite of Vital Signs and Electrocardiogram (ECG)

Timeframe: Screening up to 90 days (Discharge)

Peak Nivolumab Serum Concentration (Cmax)

Timeframe: Day 1 and subsequent days after, up to 90 days

Trough Nivolumab Serum Concentration (Cmin)

Timeframe: Day 1 and subsequent days after, up to 90 days

Average Nivolumab Serum Concentration (Cavg)

Timeframe: Day 1 and subsequent days after, up to 90 days

Time of Maximum Observed Concentration (Tmax)

Timeframe: 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)]

Timeframe: Day 1 and subsequent days after, up to 90 days