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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
The purpose of this study is to assess the effectiveness, safety, and actual treatment status of first-line nivolumab plus chemotherapy in participants with untreated advanced / recurrent gastric cancer in a Japanese real-world setting.
The Time Perspective for this observational study is defined as 'Retrospective and Prospective'.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with previously untreated advanced/recurrent gastric cancer (GC) |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Up to approximately 4 years | |
| Objective response rate (ORR) | Up to approximately 4 years | |
| Incidence of all immune-related adverse events (irAE) according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Up to approximately 4 years | |
| Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Up to approximately 4 years | |
| Duration of response (DOR) | Up to approximately 4 years | |
| Duration of treatment (DOT) |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include participants who received nivolumab plus chemotherapy as first-line treatment for unresectable advanced or recurrent gastric cancer at least once between nivolumab plus chemotherapy approval and December 31, 2022.
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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 | Minato-ku | Tokyo | 1050001 | Japan |
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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 |
|---|---|
| D013274 | Stomach Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Up to approximately 4 years |
| Time to next treatment (TNT) | Up to approximately 4 years |
| Number of participants who have received subsequent therapy | Up to approximately 4 years |
| Incidence of Adverse Events (AEs) | Up to approximately 4 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |