NCT06361576
Completed
Not Applicable
Patients With Upper Gastrointestinal Adenocarcinoma Enrolled in a Patient Support Program to Receive Nivolumab in the Metastatic Setting: Real-World Data From Canada
Overview
- Phase
- Not Applicable
- Intervention
- Nivolumab
- Conditions
- Upper Gastrointestinal Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Particpant sociodemographics
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this observational study is to describe the demographics, and disease characteristics of participants with metastatic upper gastrointestinal cancer, along with the treatment characteristics of these patients when treated with nivolumab.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Enrolled in the Bristol-Myers Squibb GastroEsophageal Opdivo in non-Resectable, advanced or metastatic Adenocarcinoma Patient Support Program (GEORgiA PsP) in Canada
- •Have consented to the use of their de-identified data generated from information collected during the course of the GEORgiA PsP
Exclusion Criteria
- •Aged \<18 years
- •HER2 positive status
- •Untreated brain metastases
Arms & Interventions
Participants enrolled and treated with nivolumab in the metastatic setting
Intervention: Nivolumab
Outcomes
Primary Outcomes
Particpant sociodemographics
Time Frame: Baseline
Participant comorbidities
Time Frame: Baseline
Participant tumour location
Time Frame: Baseline
Participant treatment history
Time Frame: Baseline
Participant Eastern Cooperative Oncology Group (ECOG) score
Time Frame: Baseline
Participant HER2 status
Time Frame: Baseline
Secondary Outcomes
- Participant adverse events (AEs)(Up to 75 weeks)
- Management of participant adverse events (AEs)(Up to 75 weeks)
- Initial nivolumab dosage prescribed to participants(Index date)
- Number of nivolumab treatments received by participants(Up to 75 weeks)
- Planned combination chemotherapy treatment(Index date)
- Nivolumab treatment initiation date(Index date)
- Nivolumab dosage modification(Up to 75 weeks)
- Participant treatment duration(Up to 75 weeks)
- Reason for participant discharge(Up to 75 weeks)
Study Sites (1)
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