Melanoma (Skin Cancer)IMPACTNCT07138222
IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma
An observational study of Melanoma (Skin Cancer), run by Peter MacCallum Cancer Centre, Australia at 6 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Melanoma (Skin Cancer)
- How many people
- 80 participants
- Where
- 6 sitesAustralia
- Study dates
- 11 Sep 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with melanoma who meet all the inclusion and none of the exclusion criteria will be eligible for the trial.
Who may be able to join
- Patients will be eligible for inclusion in this trial if all the following criteria apply:
- 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
Show all 14Show fewer
- 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
Who cannot join
- Patients will not be eligible for inclusion in this trial if any of the following criteria apply:
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christine Dijkstra, BSC, MPH contact
6 sites in 1 country
Australia6 sites, 6 recruiting
- Not yet recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Prof Victoria Atkinson
- Not yet recruiting
Cairns Base Hospital
Cairns, Queensland, 4870
Dr Megan Lyle
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Dr Wanda Cui, BMEDSCI, MBBS, FRACP, +61 3 8559 5000, wanda.cui@petermac.org
- Not yet recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
A/Prof Andrew Haydon
- Not yet recruiting
Austin Hospital
Melbourne, Victoria, 3084
Dr Damien Kee
- Not yet recruiting
Melanoma Institute Australia
Sydney, New South Wales, 2065
Prof Georgina Long
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Melanoma (Skin Cancer)
- Keywords
- melanoma, skin cancer, immune checkpoint inhibitors, immunotherapy, gonadal toxicity, ovarian function, testicular function, fertility, cytokines, inflammation
- Medical subject headings
- Melanoma, Skin Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (9)
Change in ovarian function before, during and after ICI treatment
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.
Measured: 12 months
Change in menstrual pattern before, during and after ICI treatment
To describe the change in menstrual pattern (regularity and cycle length) within 12 months of ICI treatment in premenopausal women with curable melanoma.
Measured: 12 months
Change in sexual function before, during and after ICI treatment
To describe the change in sexual function (EORTC SHQ-C22 questionnaire) within 12 months of ICI treatment in premenopausal women with curable melanoma.
Measured: 12 months
Change in circulating cytokine levels before, during and after ICI treatment
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.
Measured: 12 months
Change in testicular function before, during and after ICI treatment
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.
Measured: 12 months
Change in semen parameters before, during and after ICI treatment
To describe the change in semen parameters within 12 months of ICI treatment in men with curable melanoma.
Measured: 12 months
Change in sexual and erectile function before, during and after ICI treatment
To describe the change in sexual and erectile function (EORTC SHQ-C22 questionnaire) within 12 months of ICI treatment in men with curable melanoma.
Measured: 12 months
Change in testicular volume before, during and after ICI treatment
To describe the change in testicular volume (using orchidometry) in a subset of men with curable melanoma within 12 months of ICI treatment.
Measured: 12 months
Change in circulating cytokines before, during and after ICI treatment
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start11 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Wanda Cui, BMEDSCI, MBBS, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138222
- Sponsor's protocol ID
- HREC/117978/PMCC
- Other IDs
- ACTRN12625000395437p
- Acronym
- IMPACT
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma
- ClinicalTrials.gov ID
- NCT07138222
- Acronym / sponsor ID
- IMPACT / HREC/117978/PMCC
- Conditions
- Melanoma (Skin Cancer)
- Keywords
- melanoma, skin cancer, immune checkpoint inhibitors, immunotherapy, gonadal toxicity, ovarian function, testicular function, fertility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with melanoma who meet all the inclusion and none of the exclusion criteria will be eligible for the trial.
Key inclusion criteria (14 listed)
- Patients will be eligible for inclusion in this trial if all the following criteria apply:
- 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:
Key exclusion criteria (8 listed)
- Patients will not be eligible for inclusion in this trial if any of the following criteria apply:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
9 secondary outcomes
Change in ovarian function before, during and after ICI treatment
Time frame: 12 months
Change in menstrual pattern before, during and after ICI treatment
Time frame: 12 months
Change in sexual function before, during and after ICI treatment
Time frame: 12 months
Change in circulating cytokine levels before, during and after ICI treatment
Time frame: 12 months
Change in testicular function before, during and after ICI treatment
Time frame: 12 months
Change in semen parameters before, during and after ICI treatment
Time frame: 12 months
Change in sexual and erectile function before, during and after ICI treatment
Time frame: 12 months
Change in testicular volume before, during and after ICI treatment
Time frame: 12 months
Change in circulating cytokines before, during and after ICI treatment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Australian New Zealand Clinical Trial RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Dijkstra, BSC, MPH contact
Dr Wanda Cui, BMEDSCI, MBBS principal investigator
Peter MacCallum Cancer Centre, Australia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin Cancer), run by Peter MacCallum Cancer Centre, Australia at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Wanda Cui, BMEDSCI, MBBS (+61 3 8559 5000, wanda.cui@petermac.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ovarian reserve before, during and after ICI treatment (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.