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

Part of paid clinical trials in Sacramento, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02960854
Phase
PHASE1
Status
Completed

Conditions

  • Severe Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days

Study Details

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

Key Dates

Start date
Dec 7, 2016
Status verified
Apr 2019
Primary completion
Jan 5, 2018
Completion
Jan 5, 2018

Study Design

Enrollment
38 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Nivolumab 1
    Dose 1
  • Experimental: Nivolumab 2
    Dose 2

Primary Outcome Measure

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 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Uc Davis Medical CenterSacramentoCalifornia95817-
Univ. Of Colorado HealthColorado SpringsColorado80909-
Denver Health Medical CenterDenverColorado80204-
University Of FloridaGainesvilleFlorida32610-
Pulmonary And Critical Care Of AtlantaAtlantaGeorgia30303-
Osf Saint Francis Medical CenterPeoriaIllinois61637-
University Of KentuckyLexingtonKentucky40536-
Beth Israel Deaconess Medical Center (BIDMC)BostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Baystate Medical CenterSpringfieldMassachusetts01199-
University of Michigan, Division of Acute Care SurgeryAnn ArborMichigan48109-5008-
Washington University School Of MedicineSt LouisMissouri63110-
Duke University Medical CenterDurhamNorth Carolina27710-
The Ohio State UniversityColumbusOhio43210-
UPMCPittsburghPennsylvania15261-2500-
Harborview Medical CenterSeattleWashington98104-

Find similar trials in Sacramento, CA

By research site
Uc Davis Medical Center· Sacramento, CAUniv. Of Colorado Health· Colorado Springs, CODenver Health Medical Center· Denver, COUniversity Of Florida· Gainesville, FLPulmonary And Critical Care Of Atlanta· Atlanta, GAOsf Saint Francis Medical Center· Peoria, IL

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