CancerNCT03644498
Study to Determine if the Flu Vaccine Increases the Risk of Muscle Damage in Participants Taking Drugs That Block Certain Proteins Made by Some Types of Immune System Cells
An observational study of Cancer, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Non-Interventional
- How many people
- 1,056 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2018to 17 Oct 2018
- 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: All participants in this study will be enrolled in the PharMetrics or MarketScan database and will have exposure to at least one checkpoint inhibitor
Who may be able to join
- Treatment with a checkpoint inhibitor (CPI)
- Age greater than or equal to 18 years on date of first claim for a CPI
- ICD-9 or ICD-10 code for a malignancy within 180 days prior to the first claim for any CPI, and
- Greater than or equal to 180 days of continuous pharmaceutical and medical benefit enrollment in the database prior to the first claim for any CPI
Who cannot join
- Less than 18 years of age
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Muscle Damage in Cancer Patients Exposed to the Influenza Vaccine While Receiving Checkpoint Inhibitor Therapies: A Nested Case Control Study Using Claims Data
A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells
- Conditions
- Cancer
- Being tested
- Non-Interventional
- Keywords
- influenza, myositis, myocarditis, rhabdomyolysis, checkpoint inhibitors
- Medical subject headings
- Neoplasms, Influenza, Human, Myositis, Myocarditis, Rhabdomyolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Adults treated with a CPI therapy for cancer | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of myocarditis
Measured: Approximately 7 years
Incidence of myositis
Measured: Approximately 7 years
Incidence of rhabdomyolysis
Measured: Approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start2 May 2018
- Primary completion16 Oct 2018
- Study completion17 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,056 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
- NCT03644498
- Sponsor's protocol ID
- CA209-99J
- Status last verified
- Jan 2024
- First submitted
- 22 Aug 2018
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Muscle Damage in Cancer Patients Exposed to the Influenza Vaccine While Receiving Checkpoint Inhibitor Therapies: A Nested Case Control Study Using Claims Data
- ClinicalTrials.gov ID
- NCT03644498
- Acronym / sponsor ID
- CA209-99J
- Conditions
- Cancer
- Keywords
- influenza, myositis, myocarditis, rhabdomyolysis, checkpoint inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,056 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 May 2018 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 23 Aug 2018 (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.
A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults treated with a CPI therapy for cancer | – | Other: Non-Interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants in this study will be enrolled in the PharMetrics or MarketScan database and will have exposure to at least one checkpoint inhibitor
Key inclusion criteria (4 listed)
- Treatment with a checkpoint inhibitor (CPI)
- Age greater than or equal to 18 years on date of first claim for a CPI
- ICD-9 or ICD-10 code for a malignancy within 180 days prior to the first claim for any CPI, and
- Greater than or equal to 180 days of continuous pharmaceutical and medical benefit enrollment in the database prior to the first claim for any CPI
Key exclusion criteria (2 listed)
- Less than 18 years of age
- Other protocol defined inclusion/exclusion criteria could apply
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 |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Adults treated with a CPI therapy for cancer |
Primary outcome
Incidence of myocarditis
Time frame: Approximately 7 years
Incidence of myositis
Time frame: Approximately 7 years
Incidence of rhabdomyolysis
Time frame: Approximately 7 years
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 18 Jan 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
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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 Cancer, run by Bristol-Myers Squibb at 1 site in United States.
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 4 inclusion and 2 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 18 Jan 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 United States. 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?
Incidence of myocarditis (time frame: Approximately 7 years). The study lists 3 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 18 Jan 2024.