Real-World Use of Nivolumab for the Treatment of Patients With Metastatic Upper Gastrointestinal Cancer in Canada

Completed

• Conditions: Upper Gastrointestinal Cancer
• Interventions: Drug: Nivolumab

• Registration Number: NCT06361576
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-05
• Primary Completion: 2024-01-25
• Study Completion: 2024-01-25
• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants enrolled and treated with nivolumab in the metastatic setting	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Participant comorbidities	Baseline
Participant tumour location	Baseline
Participant treatment history	Baseline
Participant Eastern Cooperative Oncology Group (ECOG) score	Baseline
Participant HER2 status	Baseline
Particpant sociodemographics	Baseline

Secondary Outcome Measures

Name	Time	Method
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
Participant adverse events (AEs)	Up to 75 weeks
Management of participant adverse events (AEs)	Up to 75 weeks

Trial Locations

Locations (1)

Bayshore Specialty Rx Ltd.; 🇨🇦 Mississauga, Ontario, Canada