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

N/ACompletedNCT04161911

Bristol-Myers Squibb1,426 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

1,426

Conditions

Hepatocellular Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bristol Myers Squibb, CORDS Research

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Treatment patterns

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

Time frame: From aHCC diagnosis date to first nivolumab treatment (Up to 7.75 years)

Overall Survival

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

Time frame: From start date of 2L and 3L nivolumab therapy to the date of death (Up to 7.75 years)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.