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OpenTrials
Completed

NCT Number: NCT06361576

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

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Key information

Conditions

Upper Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayshore Specialty Rx Ltd.

Mississauga, Ontario, L5K 2L3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

As per product label

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2024
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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