IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma

NCT07138222 | Recruiting

• 2 other identifiers: HREC/117978/PMCCACTRN12625000395437p
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 6

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.

Conditions

Melanoma (Skin Cancer)

Keywords

melanoma; skin cancer; immune checkpoint inhibitors; immunotherapy; gonadal toxicity; ovarian function; testicular function; fertility; cytokines; inflammation

Outcome Measures

Primary Outcomes (2)

• Change in ovarian reserve before, during and after ICI treatment

  To describe the change in ovarian reserve (using AMH) within 12 months of ICI treatment in premenopausal women with curable melanoma.

  12 months

• Change in testicular function before, during and after ICI treatment

  To describe the change in testicular function (using testosterone) within 12 months of ICI treatment in men with curable melanoma.

  12 months

Secondary Outcomes (9)

• Change in ovarian function before, during and after ICI treatment

  12 months

• Change in menstrual pattern before, during and after ICI treatment

  12 months

• Change in sexual function before, during and after ICI treatment

  12 months

• Change in circulating cytokine levels before, during and after ICI treatment

  12 months

• Change in testicular function before, during and after ICI treatment

  12 months

Study Arms (2)

Cohort 1: premenopausal women with melanoma

Cohort 1: premenopausal women with melanoma, aged ≤45 years, to describe the change in: 1. ovarian reserve (using serum AMH), 2. ovarian function (using serum LH, FSH, oestradiol and related sex steroids), 3. menstrual pattern, 4. sexual function (using the European Organisation for Research and the Treatment of Cancer questionnaire for the assessment of sexual health in cancer patients (EORTC QLQ SH22), and 5. circulating cytokine levels before, during and after ICI treatment.

Cohort 2: men with melanoma

Cohort 2: men with melanoma, aged ≤60 years, to describe the change in: 6\) testicular function (using serum testosterone, FSH, LH, Sex Hormone Binding Globulin (SHBG), inhibin B and related sex steroids), 7) semen parameters (sperm concentration, count, motility, morphology), 8) sexual function (using the EORTC QLQ SH22 questionnaire, International Index of Erectile Function 5 questionnaire (IIEF-5) and the Psychosexual Daily Questionnaire Question 4 (PDQ-Q4)), 9) testicular volume (using orchidometry) in a subset of patients, and 10) circulating cytokine levels before, during and after ICI treatment.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with melanoma who meet all the inclusion and none of the exclusion criteria will be eligible for the trial.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead

Study Sites (6)

Melanoma Institute Australia

Sydney, New South Wales, 2065, Australia

NOT YET RECRUITING

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

NOT YET RECRUITING

Cairns Base Hospital

Cairns, Queensland, 4870, Australia

NOT YET RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

NOT YET RECRUITING

Austin Hospital

Melbourne, Victoria, 3084, Australia

NOT YET RECRUITING

Related Links

• Australian New Zealand Clinical Trial Registry
• Peter MacCallum Cancer Centre

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Melanoma; Skin Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Wanda Cui, BMEDSCI, MBBS

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Wanda Cui, BMEDSCI, MBBS

CONTACT

+61 3 8559 5000; wanda.cui@petermac.org

Christine Dijkstra, BSC, MPH

CONTACT

christine.dijkstra@petermac.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 22, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)