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Clinical trial

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

ID
Name
CA209-1442
Description
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.
Trial arms
Trial start
2023-09-05
Estimated PCD
2024-01-25
Trial end
2024-01-25
Status
Completed
Treatment
Nivolumab
As per product label
Arms:
Participants treated with adjuvant nivolumab
Size
250
Primary endpoint
Participant sociodemographics
Baseline
Participant Eastern Cooperative Oncology Group (ECOG) score
Baseline
Participant histology results
Baseline
Participant comorbidities
Baseline
Participant tumour location
Baseline
Date of tumour resection
Baseline
Participant primary upper gastrointestinal cancer diagnosis
Baseline
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 250, 'type': 'ACTUAL'}}
Updated at
2024-04-12

1 organization

1 product

1 indication

Organization
Bristol-Myers Squibb
Product
Nivolumab
Indication
Upper Gastrointestinal Cancer