IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma

While immune checkpoint inhibitors (ICIs) are widely used in young melanoma patients and may cause immune-related side effects, their impact on human gonadal function is unknown. Eligible patients will be identified by their oncologist and provide informed consent. Menstrual/contraceptive history, sexual function questionnaires, and blood samples for gonadal biomarkers will be collected at baseline, 3, 6, and 12 months. Semen and testicular volume (in a subset) will be assessed in men at baseline and 6 months. Patients who cease ICI before the 12 month timepoint will have also have an end of treatment assessment within 4 weeks of stopping treatment. Patients will be asked to consent to the future use of their biological samples collected during the trial. Samples will be securely stored at Peter MacCallum Cancer Centre, coded, and linked to clinical data. Patients can request sample destruction at any time, but past analyses cannot be undone. The Sponsor or delegate will manage trial data, while sites are responsible for data entry and resolving queries. Data will be entered into REDCap, a secure system hosted by Peter MacCallum Cancer Centre. Site staff will be trained, and only authorized personnel listed on the delegation log may complete eCRFs.