RecruitingNCT07138222

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

Sponsor

Peter MacCallum Cancer Centre, Australia

Enrollment

80 participants

Start Date

Sep 11, 2025

Study Type

OBSERVATIONAL

Conditions

Melanoma (Skin Cancer)

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study (IMPACT) is looking at how immune checkpoint inhibitor drugs used to treat melanoma — a type of skin cancer — may affect the reproductive health of younger men and premenopausal women. Immune checkpoint inhibitors are immunotherapy drugs that help the immune system fight cancer, but they can sometimes cause side effects in hormonal systems. **You may be eligible if...** - You have been diagnosed with melanoma (Stage II, III, or IV) and are starting treatment with an immune checkpoint inhibitor (immunotherapy) - For women: you are between 18 and 45 years old and still having regular menstrual periods (premenopausal) - For men: you are between 18 and 45 years old - Your life expectancy is at least 1 year **You may NOT be eligible if...** - You are postmenopausal or have already undergone menopause - You have a different type of cancer (not melanoma) - You do not plan to receive immunotherapy treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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