A Study to Assess Overall Survival and Treatment Patterns for Advanced Liver Cancer Participants Who Received Nivolumab Therapy

NCT ID: NCT04161911

Last Updated: 2019-11-13

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

1426 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-29

Study Completion Date

2018-11-19

Brief Summary

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A study to describe real-world treatment patterns and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy

Detailed Description

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The central aims of this study are descriptive and designed to describe the patient demographics, clinical characteristics, treatment patterns, and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy in the real-world setting.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Advanced Hepatocellular Carcinoma (aHCC) cohort

aHCC cohort selected from the Flatiron Health Oncology electronic health record (EHR) data from January 2011 to the most recent data available. The index date will be defined as the start of second or third line nivolumab therapy for aHCC between January 1, 2011 and the most recent data available.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult aHCC participants in the Flatiron database as defined by:
* Diagnosed with HCC International Classification of Diseases (ICD)-9 155.x or ICD-10 C22.x)
* Pathology consistent with advanced HCC
* Age 18 years or older at index
* At least two clinic encounters on different days in the Flatiron database occurring on or after January 1, 2011
* Participants who received second or third line nivolumab monotherapy or combination therapy for aHCC

Exclusion Criteria

* Participants with \<1 month of medical data (any clinic visits, medication administrations or oral medication prescriptions) following and including the index date
* Participants with clinical study drug during prior or post study index periods
Minimum Eligible Age

18 Years

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

Locations

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Bristol Myers Squibb, CORDS Research

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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CA209-79L

Identifier Type: -

Identifier Source: org_study_id

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