Clinical trial · Observational
CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma
CARD-IO - CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma Stage III or IV | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 12-Lead ECG | Diagnostic Test | — | UNRESOLVED |
| Basic Observations | Other | — | UNRESOLVED |
| Cardiac Biomarker Screening | Diagnostic Test | — | UNRESOLVED |
| Cardiac MRI | Diagnostic Test | — | UNRESOLVED |
| Transthoracic Echocardiogram | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 2-4 years
- description
- Patients on routine follow-up 2-4 years after the completion of immunotherapy treatment for melanoma
- interventionNames
- Diagnostic Test: 12-Lead ECG
- Diagnostic Test: Transthoracic Echocardiogram
- Diagnostic Test: Cardiac MRI
- Diagnostic Test: Cardiac Biomarker Screening
- Other: Basic Observations
- label
- 5-7
- description
- Patients on routine follow-up 5-7 years after the completion of immunotherapy treatment for melanoma
- interventionNames
- Diagnostic Test: 12-Lead ECG
- Diagnostic Test: Transthoracic Echocardiogram
- Diagnostic Test: Cardiac MRI
- Diagnostic Test: Cardiac Biomarker Screening
- Other: Basic Observations
- label
- 8-10+
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available