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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07138222
Registration number
NCT07138222
Ethics application status
Date submitted
21/07/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Titles & IDs
Public title
IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma
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Scientific title
IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma
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Secondary ID [1]
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ACTRN12625000395437p
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Secondary ID [2]
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HREC/117978/PMCC
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Universal Trial Number (UTN)
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Trial acronym
IMPACT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma (Skin Cancer)
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Condition category
Condition code
Cancer
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Malignant melanoma
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Cancer
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Non melanoma skin cancer
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in ovarian reserve before, during and after ICI treatment
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Assessment method [1]
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To describe the change in ovarian reserve (using AMH) within 12 months of ICI treatment in premenopausal women with curable melanoma.
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Timepoint [1]
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12 months
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Primary outcome [2]
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Change in testicular function before, during and after ICI treatment
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Assessment method [2]
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To describe the change in testicular function (using testosterone) within 12 months of ICI treatment in men with curable melanoma.
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Timepoint [2]
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12 months
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Secondary outcome [1]
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Change in ovarian function before, during and after ICI treatment
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Assessment method [1]
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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.
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Change in menstrual pattern before, during and after ICI treatment
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Assessment method [2]
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To describe the change in menstrual pattern (regularity and cycle length) within 12 months of ICI treatment in premenopausal women with curable melanoma.
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Change in sexual function before, during and after ICI treatment
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Assessment method [3]
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To describe the change in sexual function (EORTC SHQ-C22 questionnaire) within 12 months of ICI treatment in premenopausal women with curable melanoma.
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Timepoint [3]
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12 months
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Secondary outcome [4]
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Change in circulating cytokine levels before, during and after ICI treatment
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Assessment method [4]
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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.
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Change in testicular function before, during and after ICI treatment
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Assessment method [5]
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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.
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Timepoint [5]
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12 months
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Secondary outcome [6]
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Change in semen parameters before, during and after ICI treatment
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Assessment method [6]
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To describe the change in semen parameters within 12 months of ICI treatment in men with curable melanoma.
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Timepoint [6]
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12 months
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Secondary outcome [7]
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Change in sexual and erectile function before, during and after ICI treatment
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Assessment method [7]
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To describe the change in sexual and erectile function (EORTC SHQ-C22 questionnaire) within 12 months of ICI treatment in men with curable melanoma.
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Timepoint [7]
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12 months
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Secondary outcome [8]
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Change in testicular volume before, during and after ICI treatment
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Assessment method [8]
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To describe the change in testicular volume (using orchidometry) in a subset of men with curable melanoma within 12 months of ICI treatment.
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Timepoint [8]
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12 months
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Secondary outcome [9]
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Change in circulating cytokines before, during and after ICI treatment
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Assessment method [9]
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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.
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Timepoint [9]
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12 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/08/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2027
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Melanoma Institute Australia - Sydney
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Recruitment hospital [2]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [3]
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Cairns Base Hospital - Cairns
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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The Alfred Hospital - Melbourne
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Recruitment hospital [6]
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Austin Hospital - Melbourne
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Recruitment postcode(s) [1]
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2065 - Sydney
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Recruitment postcode(s) [2]
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4102 - Brisbane
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Recruitment postcode(s) [3]
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4870 - Cairns
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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3084 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07138222
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Wanda Cui, BMEDSCI, MBBS
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Address
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Peter MacCallum Cancer Centre, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Wanda Cui, BMEDSCI, MBBS
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Address
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Country
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Phone
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+61 3 8559 5000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07138222
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