NCT07138222Recruiting
IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- 11 Sept 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Diseases
- Melanoma
- NCT number
- NCT07138222
What you commit to
- Study type: Observational
- Planned participants: 80
- From 11 Sept 2025 to the primary completion date, Dec 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Patients will not be eligible for inclusion in this trial if any of the following criteria apply:
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Not yet recruiting |
| Cairns Base Hospital Coordinator of this site? Confirm its status | Cairns | Australia | Not yet recruiting |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Austin Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| Melanoma Institute Australia Coordinator of this site? Confirm its status | Sydney | Australia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.