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OpenTrials
Completed

NCT Number: NCT06361563

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

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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 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

Treatment and study plan

Nivolumab

Drug

As per product label

Primary outcomes

  1. Participant sociodemographics

    Time frame: Baseline

  2. Participant Eastern Cooperative Oncology Group (ECOG) score

    Time frame: Baseline

  3. Participant histology results

    Time frame: Baseline

  4. Participant comorbidities

    Time frame: Baseline

  5. Participant tumour location

    Time frame: Baseline

  6. Date of tumour resection

    Time frame: Baseline

  7. Participant primary upper gastrointestinal cancer diagnosis

    Time frame: Baseline

Secondary outcomes

  1. Initial nivolumab dosage prescribed to participants

    Time frame: Index date

  2. Number of nivolumab treatments received

    Time frame: Up to 484 days

  3. Nivolumab dosage modification

    Time frame: Up to 484 days

  4. Nivolumab treatment duration

    Time frame: Up to 484 days

  5. Reason for participant discharge

    Time frame: Up to 484 days

  6. Participant adverse events (AEs)

    Time frame: Up to 484 days

  7. Management of participant adverse events (AEs)

    Time frame: Up to 484 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Patients With Upper Gastrointestinal Cancer Enrolled in a Patient Support Program to Receive Nivolumab in the Adjuvant 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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