Melanoma Trial, Recruiting NCT07138222 Sponsor: Peter MacCallum Cancer Centre, Australia Condition: Melanoma
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Melanoma Trial, Recruiting

NCT07138222
Recruiting Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have agreed to take part by signing the official consent form for this study
  • People who have been diagnosed with melanoma at Stage II, III, or IV, whether it is a new diagnosis or the cancer has come back
  • People whose doctors expect them to live for at least one year
  • People who are planned to receive a type of cancer treatment called immune checkpoint inhibitor (ICI) therapy — either alone or combined with another treatment — before surgery, after surgery, or for melanoma that has spread
  • For the women's group (Cohort 1): Women aged 18 to 45 years old at the time of signing the consent form
  • For the women's group (Cohort 1): Women who are premenopausal, meaning their hormone levels (FSH) fall within the premenopausal range on a blood test. Women on hormonal contraception with an unusual FSH result may still be considered if another hormone level (AMH) is at or above a certain level on a blood test
  • For the women's group (Cohort 1): Women whose AMH hormone level (a measure related to egg supply) is at or above a certain level on a blood test
  • For the men's group (Cohort 2): Men aged 18 to 60 years old at the time of signing the consent form
  • For the men's group (Cohort 2): Men whose hormone levels (testosterone, LH, and FSH) are all within the normal range on a fasting morning blood test

Who may not be able to join:

  • Women who have had both ovaries surgically removed, or men who have had both testes surgically removed or have previously had a vasectomy
  • People who are planned to receive, or have previously received, radiation therapy to the pelvic area
  • People who have taken certain medications in the past 6 months that are known to affect reproductive hormones — for example, hormone-suppressing injections, certain breast cancer medications, testosterone, or anabolic steroids (confirm with trial site if unsure whether a specific medication applies)
  • People who have received certain types of chemotherapy (alkylating or platinum-based) within the past 2 years
  • People who have previously received immune checkpoint inhibitor (ICI) therapy
  • People who have a history of a condition where the body does not produce enough sex hormones (hypogonadism)
  • People who have any psychological, social, geographic, or other circumstances that the trial doctor believes could make participation not in the person's best interest, or that could affect the reliability of the study results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Dr Wanda Cui, BMEDSCI, MBBS, Peter MacCallum Cancer Centre, Australia

Phone: +61 3 8559 5000

Australian sites

Melanoma Institute Australia, Sydney, New South Wales
Princess Alexandra Hospital, Brisbane, Queensland
Cairns Base Hospital, Cairns, Queensland
Peter MacCallum Cancer Centre, Melbourne, Victoria
+61 3 8559 5000
The Alfred Hospital, Melbourne, Victoria
Austin Hospital, Melbourne, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Peter MacCallum Cancer Centre, Australia
Registry
ClinicalTrials.gov
Start date
11 September 2025
Est. completion
1 December 2026

Where this trial is recruiting

🇦🇺 Australia

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change in ovarian reserve before, during and after ICI treatment; Change in testicular function before, during and after ICI treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov