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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Hepatocellular Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT04161911

CA209-79L

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,426 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria could apply

Trial design

1,426 participants in 1 patient group

Advanced Hepatocellular Carcinoma (aHCC) cohort

Description:

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.