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Cancer immunotherapy can attack the heart: massive data hunt seeks who is most vulnerable

NCT ID NCT04294771

Knowledge-focused Sponsor: Groupe Hospitalier Pitie-Salpetriere Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Immune checkpoint inhibitors help the body's immune system fight cancer, but in some patients they trigger dangerous heart inflammation and other cardiovascular problems. Researchers are combing through the World Health Organization's global drug safety database, two French national health databases, and an international registry of myocarditis cases linked to these drugs. The goal is to identify which patients face the highest risk and what factors, such as the specific drug, dose, or drug combinations, might explain it. This is an observational study of existing records, not a test of a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
immune checkpoint inhibitors, a class of cancer immunotherapy drugs that includes ipilimumab, nivolumab, pembrolizumab, durvalumab, avelumab and atezolizumab
What this could lead to
If researchers pinpoint who faces the highest heart risk from these cancer drugs, doctors could monitor those patients more closely and catch dangerous heart inflammation earlier.
What could go wrong
This study looks back at existing reports and records rather than testing a treatment, so it can show patterns but not prove cause and effect. The findings may not apply to every patient or every cancer drug in the class.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2019

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients treated with an ICI for a cancer

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2025 * Case reported in the APHP Entrepot de Données de Santé (EDS) database of individual safety case reports to 01/01/2025 * Case reported in the Système National Des Données de Santé (SNDS) Database of individual safety case reports to 01/01/2025 * Case reported in a retrospective international multicenter registry of ICI-associated myocarditis to 01/01/2025 * Adverse event reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT) * Patients treated with ICIs included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), Cemiplimab (L01XC33) Exclusion Criteria: * Chronology not compatible between the drug and the toxicity

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Conditions

The condition(s) this trial relates to.

cardiomyopathy cardiovascular disorder heart disorder myocarditis pericarditis vasculitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiomyopathies Cardiovascular diseases Heart diseases Myocarditis Pericarditis Vasculitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.

    RECRUITING

    Paris, 75013, France

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