CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma

NCT06605833 | Enrolling By Invitation

• 1 other identifier: CCR6063
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

melanoma; cardiac toxicity; immune related adverse events; immunotherapy treatment

Outcome Measures

Primary Outcomes (1)

• Acceptance rate

  total number of patients consented divided by the number of patients invited for the study

  12 months

Secondary Outcomes (6)

• Adherence rate

  12 months

• Recruitment rate

  12 months

• Reasons for non-adherence or declining to consent

  12 months

• Difference in adherence rates

  12 months

• Proportion of patients who experience cardiovascular irAEs

  12 months

Study Arms (3)

2-4 years

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

5-7

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

8-10+

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

Interventions

12-Lead ECG DIAGNOSTIC_TEST

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

2-4 years; 5-7; 8-10+

Transthoracic Echocardiogram DIAGNOSTIC_TEST

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

2-4 years; 5-7; 8-10+

Cardiac MRI DIAGNOSTIC_TEST

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

2-4 years; 5-7; 8-10+

Cardiac Biomarker Screening DIAGNOSTIC_TEST

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

2-4 years; 5-7; 8-10+

Basic Observations OTHER

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

2-4 years; 5-7; 8-10+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Written informed consent
• Age 18 years or older
• Confirmed diagnosis of melanoma
• Stage IIB or IIC or stage III or stage IV melanoma
• Previous immunotherapy with immune-checkpoint inhibitors (anti PD-(L)1 +/- anti CTLA-4) for melanoma
• On standard of care surveillance, at 2 to 10+ years following the completion of immunotherapy treatment

You may not qualify if:

• Medical or psychological condition that would preclude informed consent.
• Known contraindications to MRI, such as claustrophobia, pregnancy, or indwelling metallic implant which is not MR conditional
• Current active treatment with systemic therapy for any malignancy.
• Active treatment with systemic therapy for any malignancy started after the completion of immunotherapy for melanoma.
• Subjects unable to comply with the study or sample schedule.
• Planned participation in a drug trial receiving investigational agents.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Royal Free Hospital NHS Foundation Trust: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW6 3JJ, United Kingdom

Location

MeSH Terms

Conditions

Melanoma; Cardiotoxicity

Interventions

Electrocardiography; Echocardiography

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: September 26, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)