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

NCT ID: NCT02856451

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

486 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-09

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Encephalitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients Treated with Nivolumab followed by Encephalitis Event

Case series reported to the sponsor from various health care facilities

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Princeton, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA209-567

Identifier Type: -

Identifier Source: org_study_id

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