A Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy in Participants With Untreated Advanced/Recurrent Gastric Cancer
NCT ID: NCT05334719
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
500 participants
OBSERVATIONAL
2022-06-29
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Cohort 1
Participants with previously untreated advanced/recurrent gastric cancer (GC)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Have initiated or are confirmed to receive nivolumab plus chemotherapy as the first-line therapy between the date of approval of nivolumab plus chemotherapy and December 31, 2022. For combination chemotherapy, SOX, CapeOX, or FOLFOX is acceptable
* Have signed a written informed consent form of their own free will after they have been given an adequate explanation and a full understanding of this study before enrolling in this study.
Exclusion Criteria
* Confirmed to be positive for HER2
* Diagnosed with gastric cancer and have previously received investigational drugs with anti-tumor effects
* Initiated with nivolumab plus chemotherapy as the first-line treatment for advanced or recurrent gastric cancer at a site other than the study site and were later hospitalized at the study site.
* Judged by the investigators to be inappropriate for enrollment in this study
20 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0001
Minato-ku, Tokyo, Japan
Countries
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Related Links
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BMS Clinical Trial Information
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-6HP
Identifier Type: -
Identifier Source: org_study_id
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