Clinical trial NCT04161911: A Study to Assess Overall Survival and Treatment Patterns for Advanced Liver Cancer Participants Who Received Nivolumab Therapy
Official title: Overall Survival and Treatment Patterns for Advanced Hepatocellular Carcinoma Patients Who Received Second or Third Line Nivolumab Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-11-13
Enrollment: 1426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study cohort will be selected from the Flatiron database according to the inclusion and exclusion criteria.

Participants will be eligible for inclusion in this study if:

1. Diagnosed with advanced Hepatocellular Carcinoma (aHCC) in the Flatiron database;
2. Aged 18 years or older at index date; and
3. Received second or third line nivolumab monotherapy or combination therapy for aHCC.

Participants will be excluded if:

1. Received clinical study drugs prior to, on, or post the index date;
2. Have less than 1 month of medical data following and including the index date. Those meeting the inclusion and exclusion criteria will be further stratified by lines of therapy and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment patterns
timeFrame: From aHCC diagnosis date to first nivolumab treatment (Up to 7.75 years)
measure: Overall Survival
timeFrame: From start date of 2L and 3L nivolumab therapy to the date of death (Up to 7.75 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bristol Myers Squibb, CORDS Research
state: New Jersey
Study officials:
References: