A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock. (NCT02960854) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Composite of Vital Signs and Electrocardiogram (ECG)
Timeframe: Screening up to 90 days (Discharge)
3
Peak Nivolumab Serum Concentration (Cmax)
Timeframe: Day 1 and subsequent days after, up to 90 days
4
Trough Nivolumab Serum Concentration (Cmin)
Timeframe: Day 1 and subsequent days after, up to 90 days
5
Average Nivolumab Serum Concentration (Cavg)
Timeframe: Day 1 and subsequent days after, up to 90 days
6
Time of Maximum Observed Concentration (Tmax)
Timeframe: 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)]