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The purpose of this observational study is to assess the effectiveness and safety of nivolumab in participants with previously untreated advanced or metastatic Gastric Cancer (GC), Gastro-oesophageal Junction (GEJ) Adenocarcinoma, or Oesophageal Adenocarcinoma (EAC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with previously untreated advanced or metastatic gastric cancer (GC), gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma (EAC) |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Defined as time since initial diagnosis and treatment with nivolumab to either the first disease progression date or last known tumour assessment date, or death due to any cause, whichever occurs first. | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include participants with previously untreated advanced or metastatic GC, GEJ adenocarcinoma or EAC that will be enrolled continuously.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Hamburg | 20246 | Germany |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009362 | Neoplasm Metastasis |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Overall response rate (ORR) | Defined as investigator assessed complete response, partial response, stable disease, or progressive disease. | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months |
| Duration of response | Defined as time from response to progression | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months |
| Incidence of Adverse Events (AEs) | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months |
| Overall Survival (OS) | Defined as time since initial diagnosis and treatment with nivolumab until date of death due to any cause. | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months |
| OS measured by Programmed Death-Ligand 1 (PD-L1) combined positive score (CPS) | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |