RecruitingACTRN12625000395437

IMmune checkPoint inhibitor related gonAdal toxiCiTy in premenopausal women and men with melanoma – the IMPACT study

Sponsor

Peter MacCallum Cancer Centre

Enrollment

80 participants

Start Date

Aug 5, 2025

Study Type

Observational

Conditions

Melanoma Menopause Hypogonadism

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. Who is it for? 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. Study details All participants who choose to enrol 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 enrol 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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

Immune checkpoint inhibitors (ICIs) are a type of cancer immunotherapy that work by removing the 'brakes' from the immune system, allowing it to attack cancer cells more aggressively. They have transformed outcomes for people with melanoma — but there are growing concerns that this immune activation may also affect the reproductive system, potentially impacting hormone levels and fertility. The IMPACT study is the first dedicated study of this question in younger adults with melanoma. It will collect blood samples, questionnaires, and (for male participants) semen samples at regular intervals during ICI treatment to track any changes in reproductive hormones and fertility markers. You may be eligible if you are aged 18–45 (for premenopausal women) or 18–60 (for men), have been diagnosed with Stage II–IV melanoma, and are about to begin ICI treatment. Women must still be premenopausal with adequate ovarian reserve. This is an observational study only — no additional treatments are involved, and it adds approximately 30 minutes to your existing treatment visits.

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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Interventions

This is a prospective study aiming to describe what happens with the gonadal function after receiving immune checkpoint inhibitor (ICI) treatment as part of standard treatment for melanoma in two cohorts of patients: 1) premenopausal woman less than or equal to 45 years and 2) men less than or equal to 60 years. ICI treatment will be delivered regardless of their involvement in the IMPACT study and will be determined by their treating clinician(s). Eligible patients will be identified by their medical oncologist at one of the participating sites and informed consent will be obtained. Contraceptive and menstrual history, sexual function questionnaires and blood for biomarkers of ovarian and testicular function will be collected at 4 timepoints during the patient’s routine treatment reviews for both cohorts: 1. Before the first dose of ICI 2. 3 months after commencing ICI 3. 6 months after commencing ICI 4. 12 months after commencing ICI In men (cohort 2), semen will also be collected 1. Before first dose of ICI 2. 6 months after commencing ICI In a subset of men (cohort 2), testicular volume will also be collected using an orchidometer 1. Before first dose of ICI 2. 6 months after commencing ICI For participants in both cohorts who discontinue ICI before 12 months, questionnaires and blood will be collected within 4 weeks after last ICI dose. As patients on ICI treatment usually have routine clinic visits and blood tests taken during treatment to make sure they are not having any side effects, we aim to collect the additional information, questionnaires and research blood tests at the same time as their routine visits and blood tests. The anticipated time needed for collection of blood for biomarkers of ovarian and testicular function is anticipated to take 10 minutes per visit, completion of contraceptive and menstrual history and sexual function questionnaires is anticipated to take 15-20 minutes per visit, collection of semen for semen analysis is anticipated to take 30 minutes per visit and measurement of testicular volume using an orchidometer is anticipated to take 10 minutes per visit.