CClinicalTrials.gg
CompletedNCT06361576Updated Apr 12, 2024

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

An observational study in Upper Gastrointestinal Cancer, sponsored by Bristol-Myers Squibb. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
700
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Upper Gastrointestinal Cancer
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In context

Gastrointestinal Neoplasms

778 studies on the registry are indexed under Gastrointestinal Neoplasms; 230 are open to participants now.

This study's enrollment of 700 is above the median of 197 across 176 observational studies indexed under Gastrointestinal Neoplasms.

Browse Gastrointestinal Neoplasms studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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)

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

Exclusion Criteria:

  • Aged \<18 years
  • HER2 positive status
  • Untreated brain metastases
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
700 participants (actual)
Patient registry
No

Groups and cohorts

  • Participants enrolled and treated with nivolumab in the metastatic setting

    Drug: Nivolumab

Interventions

  • DrugNivolumab

    As per product label

06

What researchers measure

Primary outcomes

  1. Particpant sociodemographics

    Time frame: Baseline

  2. Participant Eastern Cooperative Oncology Group (ECOG) score

    Time frame: Baseline

  3. Participant HER2 status

    Time frame: Baseline

  4. Participant comorbidities

    Time frame: Baseline

  5. Participant tumour location

    Time frame: Baseline

  6. Participant treatment history

    Time frame: Baseline

Secondary outcomes

  1. Initial nivolumab dosage prescribed to participants

    Time frame: Index date

  2. Number of nivolumab treatments received by participants

    Time frame: Up to 75 weeks

  3. Planned combination chemotherapy treatment

    Time frame: Index date

  4. Nivolumab treatment initiation date

    Time frame: Index date

  5. Nivolumab dosage modification

    Time frame: Up to 75 weeks

  6. Participant treatment duration

    Time frame: Up to 75 weeks

  7. Reason for participant discharge

    Time frame: Up to 75 weeks

  8. Participant adverse events (AEs)

    Time frame: Up to 75 weeks

  9. Management of participant adverse events (AEs)

    Time frame: Up to 75 weeks

07

Study locations

1 site
  • Bayshore Specialty Rx Ltd.
    Mississauga, Ontario L5K 2L3, Canada
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06361576
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Apr 12, 2024
Start date
Sep 5, 2023
Primary completion
Jan 25, 2024
Completion
Jan 25, 2024
Last update
Apr 12, 2024

Study contacts

Bristol Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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