Phase 1
N=31
A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.
Severe Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT02960854 ↗Enrolled (actual)
31
Serious AEs
25.8%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths — 6.7; 43.8; 93.3; 87.5 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nivolumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths |
6.7; 43.8; 93.3; 87.5; 53.3; 81.3 | — |
| PRIMARY Composite of Vital Signs and Electrocardiogram (ECG) |
-18.0; -29.0; 61.5; 58.5; 116.5; 105.5 | — |
| PRIMARY Peak Nivolumab Serum Concentration (Cmax) |
123; 246 | — |
| PRIMARY Trough Nivolumab Serum Concentration (Cmin) |
21.6; 43.2 | — |
| PRIMARY Average Nivolumab Serum Concentration (Cavg) |
42.7; 85.4 | — |
| PRIMARY Time of Maximum Observed Concentration (Tmax) |
1.67; 1.53 | — |
| PRIMARY Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] |
18099; 32130 | — |
| PRIMARY Total Clearance (CLT) |
0.025; 0.027 | — |
| PRIMARY Volume of Distribution (Vd) |
12.0; 13.3 | — |
| PRIMARY Half-life (T1/2) |
353; 378 | — |
| SECONDARY Receptor Occupancy |
0.00; 0.00; 81.272; 71.14 | — |
| SECONDARY Number of Participants With Detectable Anti-nivolumab Antibodies |
73.3; 75.0 | — |
| SECONDARY Number of Participants With Any Detectable Anti-drug Antibodies |
26.7; 56.3 | — |
Summary
A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in participants with severe sepsis or septic shock.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02960854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.