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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06361576
Enrollment
700
Registered
2024-04-12
Start date
2023-09-05
Completion date
2024-01-25
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Gastrointestinal Cancer

Brief 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.

Interventions

DRUGNivolumab

As per product label

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Particpant sociodemographicsBaseline
Participant Eastern Cooperative Oncology Group (ECOG) scoreBaseline
Participant HER2 statusBaseline
Participant comorbiditiesBaseline
Participant tumour locationBaseline
Participant treatment historyBaseline

Secondary

MeasureTime frame
Reason for participant dischargeUp to 75 weeks
Initial nivolumab dosage prescribed to participantsIndex date
Management of participant adverse events (AEs)Up to 75 weeks
Participant adverse events (AEs)Up to 75 weeks
Number of nivolumab treatments received by participantsUp to 75 weeks
Planned combination chemotherapy treatmentIndex date
Nivolumab treatment initiation dateIndex date
Nivolumab dosage modificationUp to 75 weeks
Participant treatment durationUp to 75 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026