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This study uses existing cancer registry and health record data to understand how nivolumab is used in routine care in the Netherlands for adults with advanced cancers of the esophagus, gastroesophageal junction, or stomach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced/metastatic EAC/GEJAC/GAC participants | Participants diagnosed with HER2-negative unresectable advanced (cT4B) or synchronous metastatic (cM1) esophageal adenocarcinoma (EAC), gastro-esophageal junction adenocarcinoma (GEJAC), or gastric adenocarcinoma (GAC) | ||
| Cohort 2: Participants eligible for first-line nivolumab | Subset of Cohort 1 who are eligible for nivolumab treatment according to the European Medicines Association (EMA) approved indication | ||
| Cohort 3: Participants treated with first-line nivolumab | Subset of Cohort 2 who received nivolumab as part of first-line treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | As per product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) among participants treated with first-line nivolumab | Time from start of first-line nivolumab to death from any cause among participants in Cohort 3. Associations between baseline demographic, clinical, and treatment characteristics and overall survival will be evaluated using Cox proportional hazards models. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who underwent Programmed cell Death Ligand 1 (PD-L1) testing prior to treatment initiation | Associations between baseline demographic and clinical characteristics and likelihood of PD-L1 testing will be evaluated using logistic regression models. | Baseline |
| Number of participants by Programmed cell Death Ligand 1 (PD-L1) diagnostic antibody |
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Inclusion Criteria:
Exclusion Criteria:
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Adults in the Netherlands diagnosed with HER2-negative unresectable advanced or synchronous metastatic Esophageal Adenocarcinoma (EAC), Gastro-esophageal Junction Adenocarcinoma (GEJAC), or Gastric Adenocarcinoma (GAC) diagnosed between 01-Aug-2022 and 31-Jul-2024
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Amsterdam | Netherlands |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Baseline |
| Number of participants tested for Programmed cell Death Ligand1 (PD-L1) who meet Combined Positive Score (CPS) thresholds | Baseline |
| Number of participants eligible for first-line nivolumab treatment | Baseline |
| Number of eligible participants who received first-line nivolumab treatment | Associations between baseline demographic and clinical characteristics and receipt of first-line nivolumab will be evaluated using logistic regression models. | Up to 24 months |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |