CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma

Summary

People who develop a type of skin cancer known as 'melanoma' are often treated with immunotherapy. The type of immunotherapy used for patients with melanoma is known as Immune Checkpoint Inhibitors (ICI). While ICI is very successful, it can lead to negative side effects that are known as 'immune related adverse events' (irAEs). These irAEs can affect any part of the body and can range in severity from mild symptoms to death.

There has been a lot of research on irAEs that occur during ICI, but less is known about how irAEs can affect people in the long-term.

Although irAEs are common from ICI, acute irAEs affecting the heart (cardiac irAEs) are uncommon. However, as they relate to the heart, they are often serious and have a higher rate of death compared to other types of irAEs. Little is known regarding the long-term effects of ICI on the heart. However, there is some evidence to suggest that ICI may also cause long-term cardiac irAEs such as accelerating a build-up of fatty materials in the arteries known as 'atherosclerosis' and inflammation of plaque in the heart. This can lead to an increased risk of heart attack.

Although there are guidelines for patients on ICI treatment to receive investigations to look for irAEs, including cardiac irAEs, there are no guidelines for monitoring long-term survivors.

The aim of the CARD-IO study is to establish if it is possible to investigate in long-term follow-up cardiac side-effects in patients who received ICI for melanoma. The data for this study would be used to support a larger study in the same patient population. Potentially, this could lead to a change in guidelines and long-term follow-up care for melanoma patients who have received ICI.

Conditions

• Melanoma Stage III or IV

Interventions

DIAGNOSTIC_TEST

12-Lead ECG

Participants will undergo a standard 12-lead ECG in order to record the electrical activity of the heart. This typically takes a few minutes and the ECG is read by a cardiologist This is a Standard of Care test being performed at a non Standard of Care timepoint

DIAGNOSTIC_TEST

Transthoracic Echocardiogram

A transthoracic echocardiogram will be performed in accordance to standard British Society of Echocardiography guidelines. This will involve undertaking an ultrasound scan of the participant's heart with ultrasound jelly to obtain information including left ventricular function and valvular function. This is a Standard of Care test being performed at a non Standard of Care timepoint

DIAGNOSTIC_TEST

Cardiac MRI

A cardiac MRI scan will be performed in order to assess the morphology and function of the heart in accordance with international guidelines. Data that will be derived includes biventricular volumes and function and myocardial strain data. This is a Standard of Care test being performed at a non Standard of Care timepoint

DIAGNOSTIC_TEST

Cardiac Biomarker Screening

* Cardiac Troponin I, * NTproBNP\], * lipid profile, * HbA1c * ferritin These are Standard of Care tests being performed at a non Standard of Care timepoint

OTHER

Basic Observations

* Heart rate * Blood pressure * Oxygen SAT * Respiratory rate These are Standard of Care observations being performed at a non Standard of Care timepoint

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• Royal Marsden NHS Foundation Trust

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-26

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• United Kingdom

Study Locations