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

April 8, 2024 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

250

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 Stage II or III esophageal cancer (EC) or gastroesophageal junction cancer (GEJC) that participated in the Bristol-Myers Squibb Patient Support Program (PSP) in Canada, GEORge PSP (GastroEsophageal Opdivo in Resected patients with residual pathological disease).

Description

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 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 treated with adjuvant nivolumab
Drug: Nivolumab
As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participant comorbidities
Time Frame: Baseline
Baseline
Participant Eastern Cooperative Oncology Group (ECOG) score
Time Frame: Baseline
Baseline
Participant tumour location
Time Frame: Baseline
Baseline
Participant sociodemographics
Time Frame: Baseline
Baseline
Participant histology results
Time Frame: Baseline
Baseline
Date of tumour resection
Time Frame: Baseline
Baseline
Participant primary upper gastrointestinal cancer diagnosis
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
Time Frame: Up to 484 days
Up to 484 days
Nivolumab dosage modification
Time Frame: Up to 484 days
Up to 484 days
Nivolumab treatment duration
Time Frame: Up to 484 days
Up to 484 days
Reason for participant discharge
Time Frame: Up to 484 days
Up to 484 days
Participant adverse events (AEs)
Time Frame: Up to 484 days
Up to 484 days
Management of participant adverse events (AEs)
Time Frame: Up to 484 days
Up to 484 days

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

  • CA209-1442

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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