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.
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
Monotherapy
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
Patients with melanoma who meet all the inclusion and none of the exclusion criteria will be eligible for the trial.
Cohort
Prospective
Not listed
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.
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.
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.
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.
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.
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.
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