Actively Recruiting
Immune Checkpoint Inhibitor Related Gonadal Toxicity in Premenopausal Women and Men With Melanoma
Led by Peter MacCallum Cancer Centre, Australia · Updated on 2026-01-28
80
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of immune checkpoint inhibitor (ICI) treatment on reproductive organ function and sex hormone levels in people with melanoma. This observational study focuses on adults diagnosed with Stage II, III, or IV melanoma who are planning to receive ICI therapy. The study aims to understand potential impacts of ICI treatment on sexual and reproductive health in these patients. Participants are divided into two groups: premenopausal women aged 18 to 45 and men aged 18 to 60. Women will have their ovarian reserve, ovarian function, menstrual patterns, sexual function, and cytokine levels monitored before, during, and after treatment. Men will have their testicular function, semen quality, sexual function, testicular volume, and cytokine levels assessed during the same periods. Assessments include blood tests, questionnaires, semen samples for men, and some testicular volume measurements. During the 12-month study, participants will complete questionnaires and provide blood samples at four scheduled treatment visits, each adding about 30 minutes to their usual visit time. Men will also provide semen samples at two visits, adding an extra 30 minutes. Patients stopping ICI treatment early will have an end-of-treatment assessment within four weeks. The primary outcomes measured are changes in ovarian reserve and testicular function over 12 months. Participants’ biological samples may be stored securely for future research, with options to request their destruction.
CONDITIONS
Brief Title
IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent using the IMPACT Patient Information and Consent form
- Diagnosis of Stage II, III, or IV melanoma in the de novo or recurrent setting
- Life expectancy of at least 1 year
- Planned to receive immune checkpoint inhibitor (ICI) treatment, either as monotherapy or combination therapy
- For premenopausal women: aged 18 to 45 years at consent, premenopausal status confirmed by hormone levels, and AMH level ≥ 1.0 pmol/L at registration
- For men: aged 18 to 60 years at consent and fasting morning total testosterone, LH, and FSH within normal range at registration
You will not qualify if you...
- Previous removal of both ovaries (women) or both testes or previous vasectomy (men)
- Planned for or previously had pelvic radiotherapy
- Use of medications in past 6 months known to disrupt the hypothalamic pituitary gonadal axis
- Previous or concurrent alkylating or platinum-based chemotherapy within last 2 years
- Previous use of immune checkpoint inhibitors
- History of hypogonadism
- Any psychological, social, geographical, or other condition that may interfere with study participation or assessments per investigator's opinion
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants are observed to describe changes in gonadal function and sexual health before, during, and after immune checkpoint inhibitor treatment through questionnaires and biological sample collection.
Visits at baseline, 3, 6, and 12 months, with an additional end of treatment visit within 4 weeks if treatment stops early
Trial Site Locations
Total: 6 locations
1
Melanoma Institute Australia
Sydney, New South Wales, Australia, 2065
Not Yet Recruiting
2
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Not Yet Recruiting
3
Cairns Base Hospital
Cairns, Queensland, Australia, 4870
Not Yet Recruiting
4
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
5
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Not Yet Recruiting
6
Austin Hospital
Melbourne, Victoria, Australia, 3084
Not Yet Recruiting
Research Team
D
Dr Wanda Cui, BMEDSCI, MBBS
C
Christine Dijkstra, BSC, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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