Study for people with Melanoma
Recruiting Not a phased study
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Melanoma Institute Australia | Sydney | NSW | Not yet recruiting |
| Princess Alexandra Hospital | Brisbane | QLD | Not yet recruiting |
| Cairns Base Hospital | Cairns | QLD | Not yet recruiting |
| Peter MacCallum Cancer Centre | Melbourne | VIC | Recruiting |
| The Alfred Hospital | Melbourne | VIC | Not yet recruiting |
| Austin Hospital | Melbourne | VIC | Not yet recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 28 January 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.