NCT07138222

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to capture information regarding the effect of immune checkpoint inhibitor (ICI) treatment for melanoma on reproductive organ function and sex hormone levels. You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with melanoma (Stage II, III or IV) and you are planning to receive ICI treatment. Additional criteria will apply dependent upon your biological sex characteristics. All participants who choose to enroll in this study will be asked to complete a series of questionnaires and provide blood at 4 of their scheduled treatment visits. These visits are anticipated to add 30 minutes to the scheduled visit time. Male participants will also be asked to provide semen samples at 2 of their scheduled treatment visits. These visits are anticipated to add an additional 30 minutes to the scheduled visit time. No additional or novel treatments will be offered to participants who choose to enroll in this study, this is an observational study only. It is hoped this research will contribute important information regarding the potential toxic effects of ICI treatment on sexual and reproductive function in patients with melanoma who are receiving ICI treatment.

Detailed description

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.

Conditions

• Melanoma (Skin Cancer)

Timeline

• Start date: 2025-09-11
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-08-22
• Last updated: 2026-01-28

Locations

6 sites across 1 country: Australia