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Immunotherapy's hidden danger: study probes blood vessel damage

NCT ID NCT07535944

Knowledge-focused Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will follow 200 cancer patients starting immune checkpoint inhibitors (ICIs) to see if these drugs stiffen the arteries. Researchers will measure pulse wave velocity before treatment, after 6-8 weeks, and at one year. The goal is to better understand vascular side effects like vasculitis and blood clots, which may become more common as ICI use grows.

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 (ICIs) such as nivolumab, pembrolizumab, atezolizumab, ipilimumab, cemiplimab, and others
What this could lead to
If successful, this study could help doctors understand and monitor blood vessel problems caused by immunotherapy, leading to better safety guidelines.
What could go wrong
This is an early observational study with no treatment being tested. It only measures changes in artery stiffness, so it may not capture all vascular risks or lead to direct patient benefits.

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 200 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

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 Immune Checkpoint Inhibitor (ICI) as monotherapy (curative or as an adjunct to surgery) or a combination of ICIs in the dermatology oncology department

Ages

18 years and older

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: * Patient treated with an ICI (nivolumab, pembrolizumab, atezolizumab, ipilimumab, cemiplima, or any novel antibody directed against PD-1, PD-L1, CTLA-4, or LAG-3) as monotherapy or in combination with another ICI or with radiotherapy, * Patient over 18 years of age, * WHO performance status: 0 to 2, * Oral informed consent, * Patient affiliated with or beneficiary of a social security scheme. Exclusion Criteria: * History of ICI treatment, * History of chemotherapy or targeted therapy within the last 4 weeks, * Stage 4 PAD, * Severe Raynaud's syndrome, * Removal of both hands and/or both feet, * Removal of the right hand/left foot or the left hand/right foot, * Patient deprived of liberty by an administrative or judicial decision or patient under legal protection, guardianship, or curatorship, * Pregnant or breastfeeding woman, * Patient unable to understand the study for any reason or to comply with the trial requirements (language barrier, psychological, geographical, etc.).

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Conditions

The condition(s) this trial relates to.

vascular disorder

As listed by the trial registrant

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

Vascular complications

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

  • CHU de ROUEN

    Rouen, 76031, France

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