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

Completed

• Conditions: Encephalitis
• Interventions: Biological: Nivolumab

• Registration Number: NCT02856451
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-09
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-04
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 486

Inclusion Criteria

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

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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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Treated with Nivolumab followed by Encephalitis Event	Nivolumab	Case series reported to the sponsor from various health care facilities

Primary Outcome Measures

Name	Time	Method
Outcomes of Encephalitis	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	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

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Princeton, New Jersey, United States