Real-World Use of Adjuvant Nivolumab in Patients With Upp... | NCT06361563

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

NCT06361563

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Apr 12, 2024Actual

Enrollment

250Actual

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 patient, disease and treatment characteristics of eligible participants with upper gastrointestinal cancer treated with adjuvant 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

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants treated with adjuvant nivolumab			Drug: Nivolumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Drug	As per product label	Participants treated with adjuvant nivolumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Initial nivolumab dosage prescribed to participants		Index date
Number of nivolumab treatments received		Up to 484 days
Nivolumab dosage modification

Other Outcomes

Not provided

Eligibility Module

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

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 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).

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