Clinical trial · Observational
IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1: premenopausal women with melanoma
- description
- 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.
- label
- Cohort 2: men with melanoma
- description
- 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.
Primary outcomes (2)
- measure
- Change in ovarian reserve before, during and after ICI treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available