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

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT04161911
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-10-29
• Primary Completion: 2018-11-15
• Study Completion: 2018-11-19
• Status Verified: 2019-11
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-12
• Last Update Submitted: 2019-11-12
• Study First Posted: 2019-11-13
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1426

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

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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

Other protocol-defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment patterns	From aHCC diagnosis date to first nivolumab treatment (Up to 7.75 years)	Nivolumab second and third lines of therapy will be described including prior lines of therapy, duration of nivolumab therapy and time from aHCC diagnosis date to first nivolumab treatment
Overall Survival	From start date of 2L and 3L nivolumab therapy to the date of death (Up to 7.75 years)	The initial second or third line nivolumab therapy date will be used as the start date for the OS analysis. Occurrence of death will be considered as event and the duration for event will be calculated as time from 2L or 3L nivolumab therapy date to death date. Patients who survived will be censored and their duration period will be the time between the initial 2L or 3L nivolumab therapy date and the last date of their post-period follow up

Trial Locations

Locations (1)

Bristol Myers Squibb, CORDS Research; 🇺🇸 Princeton, New Jersey, United States