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

Bristol-Myers Squibb (BMS) logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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