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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Severe Sepsis

Treatments: Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02960854

CA209-923

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Nivolumab 1

Experimental group

Description:

Dose 1

Treatment:

Biological: Nivolumab

Nivolumab 2

Experimental group

Description:

Dose 2

Treatment:

Biological: Nivolumab