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

April 8, 2024 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5K 2L3
        • Bayshore Specialty Rx Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population is comprised of individuals diagnosed with HER2 negative, unresectable, advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma (GC/GEJC/EAC) that participated in the Bristol-Myers Squibb Patient Support Program (PSP) in Canada, GEORgiA PSP (GastroEsophageal Opdivo in non-Resectable, advanced or metastatic Adenocarcinoma)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants enrolled and treated with nivolumab in the metastatic setting
Drug: Nivolumab
As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participant comorbidities
Time Frame: Baseline
Baseline
Particpant sociodemographics
Time Frame: Baseline
Baseline
Participant Eastern Cooperative Oncology Group (ECOG) score
Time Frame: Baseline
Baseline
Participant HER2 status
Time Frame: Baseline
Baseline
Participant tumour location
Time Frame: Baseline
Baseline
Participant treatment history
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Initial nivolumab dosage prescribed to participants
Time Frame: Index date
Index date
Number of nivolumab treatments received by participants
Time Frame: Up to 75 weeks
Up to 75 weeks
Planned combination chemotherapy treatment
Time Frame: Index date
Index date
Nivolumab treatment initiation date
Time Frame: Index date
Index date
Nivolumab dosage modification
Time Frame: Up to 75 weeks
Up to 75 weeks
Participant treatment duration
Time Frame: Up to 75 weeks
Up to 75 weeks
Reason for participant discharge
Time Frame: Up to 75 weeks
Up to 75 weeks
Participant adverse events (AEs)
Time Frame: Up to 75 weeks
Up to 75 weeks
Management of participant adverse events (AEs)
Time Frame: Up to 75 weeks
Up to 75 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Actual)

January 25, 2024

Study Completion (Actual)

January 25, 2024

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-1443

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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