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

NCT06361563 | Completed FDA Drug

• 1 other identifier: CA209-1442
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (7)

• Initial nivolumab dosage prescribed to participants

  Index date

• Number of nivolumab treatments received

  Up to 484 days

• Nivolumab dosage modification

  Up to 484 days

• Nivolumab treatment duration

  Up to 484 days

• Reason for participant discharge

  Up to 484 days

Study Arms (1)

Participants treated with adjuvant nivolumab

Drug: Nivolumab

Interventions

Nivolumab DRUG

As per product label

Participants treated with adjuvant nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is comprised of individuals diagnosed with Stage II or III esophageal cancer (EC) or gastroesophageal junction cancer (GEJC) that participated in the Bristol-Myers Squibb Patient Support Program (PSP) in Canada, GEORge PSP (GastroEsophageal Opdivo in Resected patients with residual pathological disease).

You may qualify if:

• 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

You may not qualify if:

• Aged \<18 years
• Did not receive concurrent chemoradiotherapy prior to surgery
• Positive margins following resection
• No residual disease following complete resection

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Bayshore Specialty Rx Ltd.

Mississauga, Ontario, L5K 2L3, Canada

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: September 5, 2023
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)