CompletedNCT03644498Updated Jan 18, 2024

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 in Cancer, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.

Sponsored by Bristol-Myers Squibb · Observational

Study type: Observational
Model: Case-control
Time perspective: Retrospective
Enrollment: 1,056
Ages: 18 Years and older
Sex: All

Study summary

A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells

Conditions studied

Cancer

Keywords

influenza
myositis
myocarditis
rhabdomyolysis
checkpoint inhibitors

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Less than 18 years of age

Other protocol defined inclusion/exclusion criteria could apply

Study design

Observational model: Case-control
Time perspective: Retrospective
Enrollment: 1,056 participants (actual)
Patient registry: No

Groups and cohorts

Adults treated with a CPI therapy for cancer
Other: Non-Interventional

Interventions

OtherNon-Interventional
Non-Interventional

What researchers measure

Primary outcomes

Incidence of myocarditis
Time frame: Approximately 7 years
Incidence of myositis
Time frame: Approximately 7 years
Incidence of rhabdomyolysis
Time frame: Approximately 7 years

Study locations

1 site

Local Institution
Princeton, New Jersey 08540, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03644498
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Aug 23, 2018
Start date: May 2, 2018
Primary completion: Oct 16, 2018
Completion: Oct 17, 2018
Last update: Jan 18, 2024

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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