Real-World Use of Adjuvant Nivolumab in Patients With Upper Gastrointestinal Cancer in Canada

Completed

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

• Registration Number: NCT06361563
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this observational study is to describe the patient, disease and treatment characteristics of eligible participants with upper gastrointestinal cancer treated with adjuvant 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: 250

Inclusion Criteria

• Enrolled in Bristol-Myers Squibb GastroEsophageal Opdivo in Resected Patients with Residual Pathological Disease Patient Support Program (GEORge PSP) in Canada
• Patients who have consented to the use of their de-identified data generated from information collected in the course of the GEORge PSP

Exclusion Criteria

• Aged <18 years
• Did not receive concurrent chemoradiotherapy prior to surgery
• Positive margins following resection
• No residual disease following complete resection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants treated with adjuvant nivolumab	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Participant primary upper gastrointestinal cancer diagnosis	Baseline
Participant comorbidities	Baseline
Date of tumour resection	Baseline
Participant Eastern Cooperative Oncology Group (ECOG) score	Baseline
Participant tumour location	Baseline
Participant sociodemographics	Baseline
Participant histology results	Baseline

Secondary Outcome Measures

Name	Time	Method
Number of nivolumab treatments received	Up to 484 days
Participant adverse events (AEs)	Up to 484 days
Initial nivolumab dosage prescribed to participants	Index date
Nivolumab treatment duration	Up to 484 days
Nivolumab dosage modification	Up to 484 days
Reason for participant discharge	Up to 484 days
Management of participant adverse events (AEs)	Up to 484 days

Trial Locations

Locations (1)

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