Impact of melanoma treatment on fertility parameters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effects of adjuvant anti-PD-1 immunotherapy and targeted therapies on ovarian reserve and semen quality in melanoma patients of childbearing age. Participants, including women aged 18 to 37 and men aged 18 to 45, will be assessed at three time points: before treatment initiation, immediately after treatment, and one year after treatment cessation. The study will measure anti-Müllerian hormone (AMH) levels and semen parameters to understand how these therapies impact fertility. A standardized questionnaire will also be used to collect data on factors that may influence fertility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must have provided a signed, dated and written consent prior to any specific procedures, sampling and analyses
* Patients with valide Health Inssurance Scheme
* Female between 18 and 37 years old and male between 18 and 45 years old
* During the 2 months before the introduction of an approved regimen of adjuvant anti-PD-1 immunotherapy or neoadjuvant plus adjuvant or targeted therapy for an high-risk of reccurence melanoma
* Adjuvant or neoadjuvant plus adjuvant treatment must be prescribed as part of routine care

Exclusion Criteria:

* Individuals deprived of liberty or placed under the authority of a tutor
* Patients unable to understand, read and/or sign an informed consent
* History of cytotoxic treatment before T0 that can alterate the studied parameters
* In male, totale motile sperm count per ejaculate inferior to 39 millions at T0
* In women, an age-specific AMH level inferior to the 10th percentile at T0
* Any condition which in the Investigator's opinion would jeopardize compliance with the protocol of the study
* Patients that will received an investigational treatment during the study timeframe (an observational research is allowed)
* Patients who have changed the type of adjuvant treatment during adjuvant treatment (targeted switch therapy versus targeted immunotherapy and vice versa) or after the neoadjuvant phase due to the pathological response obtained.

Where it's running

• CHU de Bordeaux
  Bordeaux, France Recruiting
• Ap-Hm
  Marseille, France Recruiting
• Hôpital Saint-Joseph
  Marseille, France Recruiting
• CHU Montpellier
  Montpellier, France Recruiting
• CHU de Nantes
  Nantes, France Recruiting
• CHU NICE L'archet
  Nice, France Recruiting

Study contacts

• Principal investigator: Nausicaa Malissen, MD, PhD — Ap-Hm
• Study coordinator: Nausicaa Malissen, MD, PhD
• Email: nausicaa.malissen@ap-hm.fr
• Phone: 0491384215

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Melanoma treatment with immunotherapy guided by serial ctDNA testing

  This trial tests whether regular ctDNA blood tests during treatment can help tailor the plan for patients with advanced melanoma receiving nivolumab and ipilimumab.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07930182

• Non-invasive skin-tape test to detect melanoma using methylation biomarkers

  A non-invasive skin-tape test is being tried to see if it can detect melanoma in people who are about to have a biopsy for a suspicious pigmented lesion.

  Recruiting at 4 sites Mitra Bio · Ghent and 4 other locations · NCT07883954

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• BL-M08D treatment in melanoma and other solid tumors

  A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

• Aggressive lipid lowering in melanoma patients starting immune checkpoint therapy

  This trial tests whether lowering cholesterol aggressively can reduce heart artery disease risk in melanoma patients who are just beginning immune checkpoint therapy.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT07704918

• Timing of Immunotherapy in Melanoma

  This trial tests whether starting standard melanoma immunotherapy earlier in the day (before 10 am) versus later in the day (after 1 pm) makes a difference for patients with unresectable or metastatic melanoma.

  Recruiting Radboud University Medical Center · Amsterdam and 4 other locations · NCT07696715

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.