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CompletedNCT02856451Updated Jun 30, 2022

Risk Factors and Outcomes of Immune-Mediated Encephalitis Following Exposure to Nivolumab

An observational study in Encephalitis, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-06-30.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
486
Sex
All
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Study summary

A case series analysis of encephalitis events reported to the Sponsor for patients treated with nivolumab to assess the risk factors and outcomes of immune-mediated encephalitis.

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Conditions studied

  • Encephalitis

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03

In context

Encephalitis

284 studies on the registry are indexed under Encephalitis; 56 are open to participants now.

This study's enrollment of 486 is above the median of 205 across 94 observational studies indexed under Encephalitis.

Browse Encephalitis studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Case series reported to the sponsor from various health care facilities

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Moderate, severe, life-threatening or fatal encephalitis events occurring in patients treated with nivolumab and reported to the Sponsor

Exclusion criteria

Exclusion Criteria:

  • Encephalitis cases identified through literature reviews and not reported to the Sponsor
  • Encephalitis cases identified from company-sponsored observational studies with secondary data collection
  • Spontaneous reports not submitted directly to the Sponsor

Other protocol-defined inclusion/exclusion criteria apply

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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
486 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients Treated with Nivolumab followed by Encephalitis Event

    Case series reported to the sponsor from various health care facilities

    Biological: Nivolumab

Interventions

  • BiologicalNivolumab

    Specified dose on specified days

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What researchers measure

Primary outcomes

  1. Outcomes of Encephalitis

    Time since onset of immune-mediated encephalitis to the date of outcome assessment (days) and outcomes defined as: resolved, resolving, death, physical disability (specified), cognitive disability (specified)

    Time frame: 1 year

  2. Risk factors of Encephalitis

    Potential risk factors include but are not limited to medical history including event associated signs/symptoms, and data from brain imaging diffusion, results from lumbar puncture analyses, results from serum sample analyses and results from neurologic examinations

    Time frame: 1 year

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Study locations

1 site
  • Local Institution
    Princeton, New Jersey 08540, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02856451
Responsible party
Sponsor
First posted
Aug 4, 2016
Start date
Dec 9, 2015
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Jun 30, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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