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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | From start date of 2L and 3L nivolumab therapy to the date of death (Up to 7.75 years) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply
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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:
Participants will be excluded if:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol Myers Squibb, CORDS Research | Princeton | New Jersey | 08543 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |