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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Encephalitis

Treatments: Biological: Nivolumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02856451

CA209-567

Details and patient eligibility

About

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.

Enrollment: 486 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

486 participants in 1 patient group

Patients Treated with Nivolumab followed by Encephalitis Event

Description:

Case series reported to the sponsor from various health care facilities

Treatment:

Biological: Nivolumab