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

January 26, 2026 updated by: Peter MacCallum Cancer Centre, Australia

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

While immune checkpoint inhibitors (ICIs) are widely used in young melanoma patients and may cause immune-related side effects, their impact on human gonadal function is unknown.

Eligible patients will be identified by their oncologist and provide informed consent. Menstrual/contraceptive history, sexual function questionnaires, and blood samples for gonadal biomarkers will be collected at baseline, 3, 6, and 12 months. Semen and testicular volume (in a subset) will be assessed in men at baseline and 6 months. Patients who cease ICI before the 12 month timepoint will have also have an end of treatment assessment within 4 weeks of stopping treatment.

Patients will be asked to consent to the future use of their biological samples collected during the trial. Samples will be securely stored at Peter MacCallum Cancer Centre, coded, and linked to clinical data. Patients can request sample destruction at any time, but past analyses cannot be undone.

The Sponsor or delegate will manage trial data, while sites are responsible for data entry and resolving queries. Data will be entered into REDCap, a secure system hosted by Peter MacCallum Cancer Centre. Site staff will be trained, and only authorized personnel listed on the delegation log may complete eCRFs.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2065
        • Not yet recruiting
        • Melanoma Institute Australia
        • Contact:
          • Prof Georgina Long
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Not yet recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Prof Victoria Atkinson
      • Cairns, Queensland, Australia, 4870
        • Not yet recruiting
        • Cairns Base Hospital
        • Contact:
          • Dr Megan Lyle
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter Maccallum Cancer Centre
        • Contact:
      • Melbourne, Victoria, Australia, 3004
        • Not yet recruiting
        • The Alfred Hospital
        • Contact:
          • A/Prof Andrew Haydon
      • Melbourne, Victoria, Australia, 3084
        • Not yet recruiting
        • Austin Hospital
        • Contact:
          • Dr Damien Kee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ovarian reserve before, during and after ICI treatment
Time Frame: 12 months
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
Time Frame: 12 months
To describe the change in testicular function (using testosterone) within 12 months of ICI treatment in men with curable melanoma.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ovarian function before, during and after ICI treatment
Time Frame: 12 months
To describe the change in FSH, LH, oestradiol and related sex steroids (DHT, estrone, DHEA, progesterone) by LC-MS assessed on serum within 12 months of ICI treatment in premenopausal women with curable melanoma.
12 months
Change in menstrual pattern before, during and after ICI treatment
Time Frame: 12 months
To describe the change in menstrual pattern (regularity and cycle length) within 12 months of ICI treatment in premenopausal women with curable melanoma.
12 months
Change in sexual function before, during and after ICI treatment
Time Frame: 12 months
To describe the change in sexual function (EORTC SHQ-C22 questionnaire) within 12 months of ICI treatment in premenopausal women with curable melanoma.
12 months
Change in circulating cytokine levels before, during and after ICI treatment
Time Frame: 12 months
To describe the change in circulating cytokine levels (TNF-alpha, IL-1a, IL-1b, IL-10, IL-6, IFN-gamma and granzyme A and B levels) with 12 months of ICI treatment and if cytokine levels are associated with AMH, LH, FSH and oestradiol levels in premenopausal women with curable melanoma.
12 months
Change in testicular function before, during and after ICI treatment
Time Frame: 12 months
To describe the change in testicular function (using serum FSH, LH, Sex Hormone Binding Globulin (SHBG), inhibin B and related sex steroids) within 12 months of ICI treatment in men with curable melanoma.
12 months
Change in semen parameters before, during and after ICI treatment
Time Frame: 12 months
To describe the change in semen parameters within 12 months of ICI treatment in men with curable melanoma.
12 months
Change in sexual and erectile function before, during and after ICI treatment
Time Frame: 12 months
To describe the change in sexual and erectile function (EORTC SHQ-C22 questionnaire) within 12 months of ICI treatment in men with curable melanoma.
12 months
Change in testicular volume before, during and after ICI treatment
Time Frame: 12 months
To describe the change in testicular volume (using orchidometry) in a subset of men with curable melanoma within 12 months of ICI treatment.
12 months
Change in circulating cytokines before, during and after ICI treatment
Time Frame: 12 months
To describe the change in circulating cytokine levels within 12 months of ICI treatment and if cytokine levels are associated with FSH, LH, SHBG, testosterone, and semen analysis in men with curable melanoma.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter MacCallum Cancer Centre, Australia

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 21, 2025

First Submitted That Met QC Criteria

August 17, 2025

First Posted (Actual)

August 22, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC/117978/PMCC
  • ACTRN12625000395437p (Other Identifier: ANZCTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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