This trial is active, not recruiting.

Condition encephalitis
Treatment nivolumab
Target PD-1
Sponsor Bristol-Myers Squibb
Start date January 2016
End date December 2021
Trial size 60 participants
Trial identifier NCT02856451, CA209-567


A case series analyses of encephalitis events reported to the Sponsor for patients treated with nivolumab to assess the risk factors and outcomes of immune-mediated encephalitis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Case series reported to the sponsor from various health care facilities
Specified dose on specified days

Primary Outcomes

Outcomes of Encephalitis
time frame: 1 year
Risk factors of Encephalitis
time frame: 1 year

Eligibility Criteria

Male or female participants of any age.

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 could apply

Additional Information

Official title Case Series Analyses of the Risk Factors and Outcomes of Immune-Mediated Encephalitis Following Exposure to Nivolumab
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.