Overview

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

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

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

Primary Outcomes

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

Eligibility Criteria

All 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 January 2017.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.