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

Upper Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06361576
• Other study ID #: CA209-1443
• 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 demographics, and disease characteristics of participants with metastatic upper gastrointestinal cancer, along with the treatment characteristics of these patients when treated with nivolumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• 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 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

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	Particpant sociodemographics		Baseline
Primary	Participant Eastern Cooperative Oncology Group (ECOG) score		Baseline
Primary	Participant HER2 status		Baseline
Primary	Participant comorbidities		Baseline
Primary	Participant tumour location		Baseline
Primary	Participant treatment history		Baseline
Secondary	Initial nivolumab dosage prescribed to participants		Index date
Secondary	Number of nivolumab treatments received by participants		Up to 75 weeks
Secondary	Planned combination chemotherapy treatment		Index date
Secondary	Nivolumab treatment initiation date		Index date
Secondary	Nivolumab dosage modification		Up to 75 weeks
Secondary	Participant treatment duration		Up to 75 weeks
Secondary	Reason for participant discharge		Up to 75 weeks
Secondary	Participant adverse events (AEs)		Up to 75 weeks
Secondary	Management of participant adverse events (AEs)		Up to 75 weeks

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls