Hepatocellular CarcinomaNCT04161911
A Study to Assess Overall Survival and Treatment Patterns for Advanced Liver Cancer Participants Who Received Nivolumab Therapy
An observational study of Hepatocellular Carcinoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 1,426 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to 19 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Bristol Myers Squibb, CORDS Research
Princeton, New Jersey, 08543
About this study
Official title: Overall Survival and Treatment Patterns for Advanced Hepatocellular Carcinoma Patients Who Received Second or Third Line 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
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Hepatocellular Carcinoma (aHCC) cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From start date of 2L and 3L nivolumab therapy to the date of death (Up to 7.75 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start29 Oct 2018
- Primary completion15 Nov 2018
- Study completion19 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161911
- Sponsor's protocol ID
- CA209-79L
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overall Survival and Treatment Patterns for Advanced Hepatocellular Carcinoma Patients Who Received Second or Third Line Nivolumab Therapy
- ClinicalTrials.gov ID
- NCT04161911
- Acronym / sponsor ID
- CA209-79L
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,426 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Hepatocellular Carcinoma (aHCC) cohort | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment patterns (time frame: From aHCC diagnosis date to first nivolumab treatment (Up to 7.75 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.