An observational study in Melanoma Stage III or IV, sponsored by Royal Marsden NHS Foundation Trust. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Royal Marsden NHS Foundation Trust · Observational
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.
Primary aim • To establish the feasibility of conducting a study to investigate late cardiac side effects caused by immunotherapy in patients with melanoma in order to generate data to support a larger study in this patient population.
Secondary aims
Primary endpoint
Secondary endpoints
The planned sample size is 60 participants.
The project will assess 3 groups of patients at different timepoints during their standard of care surveillance, at 2-4, 5-7 and 8-10 years following the completion of their immunotherapy treatment for melanoma. Patients on routine follow-up, at 2 to 10 years following the completion of immunotherapy treatment for melanoma will be identified by searching through database of patients with melanoma who received immune checkpoint inhibitors (ICI). Patients respecting the inclusion criteria will be invited to take to part to the study.
Patients included in the study will undergo screening blood tests including cardiac biomarkers (troponin I, NTproBNP, lipid profile, HbA1c, ferritin), a 12 lead ECG and transthoracic echocardiography, a cardiac MRI alongside completing a questionnaire about cardiac events and risk factors. Patients will have blood tests done at Royal Marsden or Royal Free, while all the other cardiac investigations (ECG, transthoracic echocardiography, cardiac MRI) will be performed at the Royal Brompton Hospital. Surveillance imaging performed as per standard of care at the Royal Marsden or at the Royal Free will be reviewed for evidence of atherosclerosis by the team at the Royal Brompton. The cardiology team at the Royal Brompton will review cardiac investigations' results and abnormal results will be flagged.
A summary report will be generated and sent to the patients, their GPs, and the Site irrespective of the results found, and abnormal results will be investigated as per standard of care. The prevalence of cardiac adverse events will be summarised.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's planned enrollment of 60 is below the median of 187 across 488 observational studies indexed under Melanoma.
Browse Melanoma studies →Royal Marsden NHS Foundation Trust is the lead sponsor of 273 studies on the registry; 53 are open to participants now.
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Patients from The Royal Marsden NHS Foundation Trust (RMH) and the Royal Free London NHS Trust (RFH) who are in follow up after receiving immunotherapy for melanoma 2-10+ years prior to enrolment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients on routine follow-up 2-4 years after the completion of immunotherapy treatment for melanoma
Diagnostic Test: 12-Lead ECG · Diagnostic Test: Transthoracic Echocardiogram · Diagnostic Test: Cardiac MRI · Diagnostic Test: Cardiac Biomarker Screening · Other: Basic Observations
Patients on routine follow-up 5-7 years after the completion of immunotherapy treatment for melanoma
Diagnostic Test: 12-Lead ECG · Diagnostic Test: Transthoracic Echocardiogram · Diagnostic Test: Cardiac MRI · Diagnostic Test: Cardiac Biomarker Screening · Other: Basic Observations
Patients on routine follow-up 8-10+ years after the completion of immunotherapy treatment for melanoma
Diagnostic Test: 12-Lead ECG · Diagnostic Test: Transthoracic Echocardiogram · Diagnostic Test: Cardiac MRI · Diagnostic Test: Cardiac Biomarker Screening · Other: Basic Observations
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
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
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
* Cardiac Troponin I, * NTproBNP\], * lipid profile, * HbA1c * ferritin These are Standard of Care tests being performed at a non Standard of Care timepoint
* Heart rate * Blood pressure * Oxygen SAT * Respiratory rate These are Standard of Care observations being performed at a non Standard of Care timepoint
Acceptance rate
total number of patients consented divided by the number of patients invited for the study
Time frame: 12 months
Adherence rate
proportion of patients completing all the scheduled cardiac screening tests divided by the number of patients enrolled in the study
Time frame: 12 months
Recruitment rate
Number of patients recruited on average per month in each site, and overall
Time frame: 12 months
Reasons for non-adherence or declining to consent
Reasons for non-adherence or declining to consent
Time frame: 12 months
Difference in adherence rates
Difference in adherence rates between adjuvant early disease setting and metastatic setting
Time frame: 12 months
Proportion of patients who experience cardiovascular irAEs
Proportion of patients who experience cardiovascular irAEs during long-term follow-up, post-treatment
Time frame: 12 months
Prevalence of cardiac irAEs
Prevalence of cardiac irAEs
Time frame: 12 months
Plan to share: No — This is a feasibility study to support the application of a larger more complex study by the same team on the same topic. Sharing of IPD would require additional consents and level of complexity in the Data Plan which current resource restraints does not allow. This will be considered for future studies based on this research.
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