Upper Gastrointestinal CancerNCT06361563
Real-World Use of Adjuvant Nivolumab in Patients With Upper Gastrointestinal Cancer in Canada
An observational study of Upper Gastrointestinal Cancer, run by Bristol-Myers Squibb at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Cancer
- What is being tested?
- Nivolumab
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 5 Sep 2023to 25 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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).
Who may be able to join
- 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
Who cannot join
- Aged <18 years
- Did not receive concurrent chemoradiotherapy prior to surgery
- Positive margins following resection
- No residual disease following complete resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients With Upper Gastrointestinal Cancer Enrolled in a Patient Support Program to Receive Nivolumab in the Adjuvant Setting: Real World Data From Canada
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
- Being tested
- Nivolumab
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with adjuvant nivolumab | Not described Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant sociodemographics
Measured: Baseline
Participant Eastern Cooperative Oncology Group (ECOG) score
Measured: Baseline
Participant histology results
Measured: Baseline
Participant comorbidities
Measured: Baseline
Participant tumour location
Measured: Baseline
Date of tumour resection
Measured: Baseline
Participant primary upper gastrointestinal cancer diagnosis
Measured: Baseline
Secondary outcomes (7)
Initial nivolumab dosage prescribed to participants
Measured: Index date
Number of nivolumab treatments received
Measured: Up to 484 days
Nivolumab dosage modification
Measured: Up to 484 days
Nivolumab treatment duration
Measured: Up to 484 days
Reason for participant discharge
Measured: Up to 484 days
Participant adverse events (AEs)
Measured: Up to 484 days
Management of participant adverse events (AEs)
Measured: Up to 484 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start5 Sep 2023
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361563
- Sponsor's protocol ID
- CA209-1442
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Upper Gastrointestinal Cancer Enrolled in a Patient Support Program to Receive Nivolumab in the Adjuvant Setting: Real World Data From Canada
- ClinicalTrials.gov ID
- NCT06361563
- Acronym / sponsor ID
- CA209-1442
- Conditions
- Upper Gastrointestinal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants treated with adjuvant nivolumab | – | Drug: Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Aged <18 years
- Did not receive concurrent chemoradiotherapy prior to surgery
- Positive margins following resection
- No residual disease following complete resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAs per product label | Drug | Participants treated with adjuvant nivolumab |
Primary outcome
Participant sociodemographics
Time frame: Baseline
Participant Eastern Cooperative Oncology Group (ECOG) score
Time frame: Baseline
Participant histology results
Time frame: Baseline
Participant comorbidities
Time frame: Baseline
Participant tumour location
Time frame: Baseline
Date of tumour resection
Time frame: Baseline
Participant primary upper gastrointestinal cancer diagnosis
Time frame: Baseline
7 secondary outcomes
Initial nivolumab dosage prescribed to participants
Time frame: Index date
Number of nivolumab treatments received
Time frame: Up to 484 days
Nivolumab dosage modification
Time frame: Up to 484 days
Nivolumab treatment duration
Time frame: Up to 484 days
Reason for participant discharge
Time frame: Up to 484 days
Participant adverse events (AEs)
Time frame: Up to 484 days
Management of participant adverse events (AEs)
Time frame: Up to 484 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gastrointestinal Cancer, run by Bristol-Myers Squibb at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant sociodemographics (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.