CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma

Launched by ROYAL MARSDEN NHS FOUNDATION TRUST · Sep 18, 2024

Keywords

ClinConnect Summary

The ATRIUM study is a clinical trial that aims to explore the long-term effects of immunotherapy, specifically a treatment called immune checkpoint inhibitors (ICI), on the heart of patients who have been treated for advanced melanoma (a type of skin cancer). While ICI treatments can be very effective, they sometimes cause side effects known as immune-related adverse events (irAEs), which can affect various parts of the body. This study is particularly interested in understanding the potential long-term heart-related side effects that can occur after treatment, as these can be serious and increase the risk of heart problems.

To be eligible for the trial, participants must be at least 18 years old, have a confirmed diagnosis of melanoma at a high risk or advanced stage, and have previously received ICI treatment. They should also be in regular follow-up care, at least 2 years after completing their immunotherapy. Participants in the study will undergo evaluations to check for any heart-related issues that may have developed over time due to their treatment. This research could help improve guidelines for monitoring the heart health of melanoma patients after their immunotherapy, ensuring they receive the best possible care as they move forward.

Gender

ALL

Eligibility criteria

• 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.