Real-World Use of Nivolumab for the Treatment of Patients... | NCT06361576

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

NCT06361576

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Apr 12, 2024Actual

Enrollment

700Actual

Phase

Not provided

Conditions

Upper Gastrointestinal Cancer

Interventions

Nivolumab

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2023Actual

Primary Completion Date

Jan 25, 2024Actual

Completion Date

Jan 25, 2024Actual

First Submitted Date

Apr 8, 2024

First Submission Date that Met QC Criteria

Apr 8, 2024

First Posted Date

Apr 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2024

Last Update Posted Date

Apr 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

700Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants enrolled and treated with nivolumab in the metastatic setting			Drug: Nivolumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Drug	As per product label	Participants enrolled and treated with nivolumab in the metastatic setting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Initial nivolumab dosage prescribed to participants		Index date
Number of nivolumab treatments received by participants		Up to 75 weeks
Planned combination chemotherapy treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bayshore Specialty Rx Ltd.		Mississauga	Ontario	L5K 2L3	Canada

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
FDA Safety Alerts and Recalls	View source

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins