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

NCT06361576 | Completed FDA Drug

• 1 other identifier: CA209-1443
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (6)

• Particpant sociodemographics

  Baseline

• Participant Eastern Cooperative Oncology Group (ECOG) score

  Baseline

• Participant HER2 status

  Baseline

• Participant comorbidities

  Baseline

• Participant tumour location

  Baseline

• Participant treatment history

  Baseline

Secondary Outcomes (9)

• Initial nivolumab dosage prescribed to participants

  Index date

• Number of nivolumab treatments received by participants

  Up to 75 weeks

• Planned combination chemotherapy treatment

  Index date

• Nivolumab treatment initiation date

  Index date

• Nivolumab dosage modification

  Up to 75 weeks

Study Arms (1)

Participants enrolled and treated with nivolumab in the metastatic setting

Drug: Nivolumab

Interventions

Nivolumab DRUG

As per product label

Participants enrolled and treated with nivolumab in the metastatic setting

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 HER2 negative, unresectable, advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma (GC/GEJC/EAC) that participated in the Bristol-Myers Squibb Patient Support Program (PSP) in Canada, GEORgiA PSP (GastroEsophageal Opdivo in non-Resectable, advanced or metastatic Adenocarcinoma)

You may qualify if:

• 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

You may not qualify if:

• Aged \<18 years
• HER2 positive status
• Untreated brain metastases

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)