Status:
NOT_YET_RECRUITING
IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Conditions:
Melanoma (Skin Cancer)
Eligibility:
All Genders
18-60 years
Brief 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 ...
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 wi...
Eligibility Criteria
Inclusion
- Patients will be eligible for inclusion in this trial if all the following criteria apply:
- Patient has provided written informed consent using the IMPACT Patient Information and Consent form (PICF)
- Diagnosis of melanoma (Stage II, III or IV) in the de novo or recurrent setting
- Has a life expectancy of greater than or equal to 1 year
- Planned to receive ICI treatment, either in the neoadjuvant, adjuvant or metastatic setting, including as:
- Monotherapy
- Combination therapy
- For cohort 1: premenopausal women with melanoma
- Age greater than or equal to 18 and less than or equal to 45 years at the time of signing consent
- Patient is premenopausal (defined as baseline FSH within the premenopausal range per local laboratory at registration). Women on hormonal contraception who have an abnormal FSH level, will be included if their AMH level is greater than or equal to 1.0 pmol/L at registration
- AMH level greater than or equal to 1.0 pmol/L at registration
- For Cohort 2: men with melanoma
- Age greater than or equal to 18 and less than or equal to 60 years at the time of signing consent
- Fasting morning total testosterone, LH and FSH within the normal range (per local laboratory) at the time registration
Exclusion
- Patients will not be eligible for inclusion in this trial if any of the following criteria apply:
- Previous removal of both ovaries (females) or previous removal of both testes or previous vasectomy (males)
- Planned for or previously had pelvic radiotherapy
- Any medications within the prior 6 months known to disrupt the hypothalamic pituitary gonadal axis, e.g., GnRH agonists or antagonists, selective estrogen receptor modulators (SERMs), aromatase inhibitors, testosterone, anabolic steroids, etc.
- Previous or concurrent alkylating or platinum-based chemotherapy within the last 2 years
- Previous use of ICI
- History of hypogonadism
- Presence of any psychological, social, geographical, or other condition for which, in the opinion of the site Investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07138222
Start Date
August 1 2025
End Date
December 1 2027
Last Update
August 22 2025
Active Locations (6)
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1
Melanoma Institute Australia
Sydney, New South Wales, Australia, 2065
2
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
3
Cairns Base Hospital
Cairns, Queensland, Australia, 4870
4
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000