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

Upper Gastrointestinal Cancer Clinical Trial

Official title:

Patients With Upper Gastrointestinal Cancer Enrolled in a Patient Support Program to Receive Nivolumab in the Adjuvant Setting: Real World Data From Canada

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06361563
• Other study ID #: CA209-1442
• Status: Completed
• Start date: September 5, 2023
• Est. completion date: January 25, 2024

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Neoplasms
• Upper Gastrointestinal Cancer

Intervention

Drug:
• Nivolumab
As per product label

Locations

Country	Name	City	State
Canada	Bayshore Specialty Rx Ltd.	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant sociodemographics		Baseline
Primary	Participant Eastern Cooperative Oncology Group (ECOG) score		Baseline
Primary	Participant histology results		Baseline
Primary	Participant comorbidities		Baseline
Primary	Participant tumour location		Baseline
Primary	Date of tumour resection		Baseline
Primary	Participant primary upper gastrointestinal cancer diagnosis		Baseline
Secondary	Initial nivolumab dosage prescribed to participants		Index date
Secondary	Number of nivolumab treatments received		Up to 484 days
Secondary	Nivolumab dosage modification		Up to 484 days
Secondary	Nivolumab treatment duration		Up to 484 days
Secondary	Reason for participant discharge		Up to 484 days
Secondary	Participant adverse events (AEs)		Up to 484 days
Secondary	Management of participant adverse events (AEs)		Up to 484 days

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls