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

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bristol Myers Squibb, CORDS Research

Princeton, New Jersey, 08543, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Treatment patterns

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Overall Survival and Treatment Patterns for Advanced Hepatocellular Carcinoma Patients Who Received Second or Third Line Nivolumab Therapy

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Nov 13, 2019
Registry last updated: Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed