NCT07138222 IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma
| NCT ID | NCT07138222 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peter MacCallum Cancer Centre, Australia |
| Condition | Melanoma (Skin Cancer) |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-09-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: Patients will be eligible for inclusion in this trial if all the following criteria apply: 1. Patient has provided written informed consent using the IMPACT Patient Information and Consent form (PICF) 2. Diagnosis of melanoma (Stage II, III or IV) in the de novo or recurrent setting 3. Has a life expectancy of greater than or equal to 1 year 4. 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 5. Age greater than or equal to 18 and less than or equal to 45 years at the time of signing consent 6. 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 7. AMH level greater than or equal to 1.0 pmol/L at registration For Cohort 2: men with melanoma 8. Age greater than or equal to 18 and less than or equal to 60 years at the time of signing consent 9. Fasting morning total testosterone, LH and FSH within the normal range (per local laboratory) at the time registration Exclusion Criteria: Patients will not be eligible for inclusion in this trial if any of the following criteria apply: 1. Previous removal of both ovaries (females) or previous removal of both testes or previous vasectomy (males) 2. Planned for or previously had pelvic radiotherapy 3. 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. 4. Previous or concurrent alkylating or platinum-based chemotherapy within the last 2 years 5. Previous use of ICI 6. History of hypogonadism 7. 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
Contact & Investigator
Dr Wanda Cui, BMEDSCI, MBBS
PRINCIPAL INVESTIGATOR
Peter MacCallum Cancer Centre, Australia
Frequently Asked Questions
Who can join the NCT07138222 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Melanoma (Skin Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07138222 currently recruiting?
Yes, NCT07138222 is actively recruiting participants. Contact the research team at wanda.cui@petermac.org for enrollment information.
Where is the NCT07138222 trial being conducted?
This trial is being conducted at Sydney, Australia, Brisbane, Australia, Cairns, Australia, Melbourne, Australia and 2 additional locations.
Who is sponsoring the NCT07138222 clinical trial?
NCT07138222 is sponsored by Peter MacCallum Cancer Centre, Australia. The principal investigator is Dr Wanda Cui, BMEDSCI, MBBS at Peter MacCallum Cancer Centre, Australia. The trial plans to enroll 80 participants.
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