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
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Diagnosed with 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 treatment as monotherapy or combination therapy
- For premenopausal women: age 18 to 45 years at consent
- Premenopausal status confirmed by baseline FSH or AMH level 1.0 pmol/L for women on hormonal contraception
- For men: age 18 to 60 years at consent
- Normal fasting morning total testosterone, LH, and FSH levels at registration
You will not qualify if you...
- Previous removal of both ovaries (females) or both testes or previous vasectomy (males)
- Planned for or previously had pelvic radiotherapy
- Use of medications within prior 6 months that disrupt the hypothalamic pituitary gonadal axis (e.g., GnRH agonists/antagonists, SERMs, aromatase inhibitors, testosterone, anabolic steroids)
- Alkylating or platinum-based chemotherapy within the past 2 years
- Previous use of immune checkpoint inhibitors
- History of hypogonadism
- Any psychological, social, geographical, or other condition that may limit participation or affect assessments as judged by the investigator
AI-Screening
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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
CONTACT
C
Christine Dijkstra, BSC, MPH
CONTACT
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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