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

Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856451
• Other study ID #: CA209-567
• Status: Completed
• Start date: December 9, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Encephalitis

Intervention

Biological:
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year
Primary	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	1 year

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form