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IMPACT: IMmune checkPoint inhibitor related gonAdal toxiCiTy in premenopausal women and men with melanoma

A prospective Australian multi-site cohort study

A prospective Australian multi-site cohort study

Cancer treatments can irreversibly damage the ovaries or testes, causing infertility, early menopause, or low testosterone, with long-term health effects such as osteoporosis, cardiovascular disease, and cognitive or sexual dysfunction. These risks are critical to patients’ treatment and family planning decisions. However, the impact of newer therapies like immunotherapy on gonadal function is unknown.

Immune checkpoint inhibitors (ICI), commonly used in young melanoma patients, boost anti-tumour immunity but may also cause systemic inflammation. With increasing survival and remission rates, fertility and hormonal health concerns are both relevant and patient driven. Preclinical studies show a 50% reduction in oocyte count in mice treated with ICI, indicating possible fertility impacts. Yet, robust human data is lacking, limiting informed decision making for patients.

IMPACT is a cohort study in premenopausal women aged under 45 years and men aged under 60 with melanoma to assess the impact of ICI on gonadal function. This study will be the first to prospectively assess the impact of ICI on ovarian function in humans and will also contribute to the limited evidence on their effects on male gonadal function.

Dr Wanda Cui is the coordinating principal investigator at the Department of Medical Oncology, Peter MacCallum Cancer Centre (sponsor).

Objectives

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 SHQ-C22) (14, 15)
  5. Circulating cytokine levels before, during and after ICI treatment

Cohort 2

Men with melanoma, aged ≤60 years, to describe the change in:

  1. Testicular function (using serum testosterone, FSH, LH, Sex Hormone Binding Globulin (SHBG), inhibin B and related sex steroids)
  2. Semen parameters (sperm concentration, count, motility, morphology)
  3. Sexual function (using the EORTC SHQ-C22 questionnaire, International Index of Erectile Function 5 questionnaire (IIEF-5) and the Psychosexual Daily Questionnaire Question 4 (PDQ-Q4))
  4. Testicular volume (using orchidometry) in a subset of patients
  5. Circulating cytokine levels before, during and after ICI treatment

Eligibility Criteria 

Inclusion criteria
Exclusion criteria

Recuritment sites | Investigator Sites

Recruitment sites

 

Funding

This study has been funded under the Cancer Council Victoria Grants in Aid 2024.

Project status

Not yet recruiting

Contact details

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Coordinating Principal Investigator: Dr Wanda Cui

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Clinical Research Coordinator: Christine Dijkstra

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More information about this study can be found at: ANZCTR

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