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

Completed

Conditions studied: Encephalitis

In brief

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.

Key facts

Study ID

NCT02856451

Run by

Bristol-Myers Squibb

People needed

486

Starts

2015-12-09

Expected to finish

2020-12-31

Last updated by the study team

2022-06-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Local Institution — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.