Does immunotherapy for melanoma affect reproductive organs in premenopausal women and men?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults with Stage II–IV melanoma who are planning to receive immune checkpoint inhibitors and collects clinical data, questionnaires, and biospecimens over 12 months. Blood for gonadal biomarkers will be taken at baseline, 3, 6, and 12 months, with semen samples and testicular measures collected in men at selected timepoints and menstrual/contraceptive history and sexual function questionnaires collected in women. Participants who stop treatment early will have an end-of-treatment assessment within four weeks of stopping. No additional treatments are given and biological samples may be stored for future research with participant consent at Peter MacCallum Cancer Centre.

Why it matters

Who can join: the full rules

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

Where it's running

• Peter MacCallum Cancer Centre
  Melbourne, Victoria, Australia Recruiting
• Melanoma Institute Australia
  Sydney, New South Wales, Australia Not yet recruiting
• Princess Alexandra Hospital
  Brisbane, Queensland, Australia Not yet recruiting
• Cairns Base Hospital
  Cairns, Queensland, Australia Not yet recruiting
• The Alfred Hospital
  Melbourne, Victoria, Australia Not yet recruiting
• Austin Hospital
  Melbourne, Victoria, Australia Not yet recruiting

Study contacts

• Principal investigator: Dr Wanda Cui, BMEDSCI, MBBS — Peter MacCallum Cancer Centre, Australia
• Study coordinator: Dr Wanda Cui, BMEDSCI, MBBS
• Email: wanda.cui@petermac.org
• Phone: +61 3 8559 5000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.