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

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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Key information

Conditions

Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases Neuroinflammatory Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Nivolumab

Biological

Specified dose on specified days

Primary outcomes

Outcomes of Encephalitis

Time frame: 1 year

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)
Risk factors of Encephalitis

Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Case Series Analyses of the Risk Factors and Outcomes of Immune-Mediated Encephalitis Following Exposure to Nivolumab

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2020
First posted: Aug 4, 2016
Registry last updated: Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed