Adjuvant melanoma treatments and fertility after surgery

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 will follow women under 40 with completely resected stage II–IV melanoma who either undergo observation or receive adjuvant treatments such as dabrafenib plus trametinib, pembrolizumab, or nivolumab. Investigators will collect menstrual history, ovarian reserve markers (for example AMH), and subsequent pregnancy outcomes over time. The study compares reproductive outcomes and ovarian function between patients exposed to MAPK inhibitors or immune checkpoint inhibitors and those not receiving adjuvant systemic therapy. Findings are intended to guide fertility-preservation discussions for reproductive-age melanoma survivors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Stage II, III, IV completely resected melanoma
2. Female sex
3. Under 40 years of age
4. Not previously treated with chemotherapy and/or radiotherapy
5. Being able to give written informed consent.

Exclusion Criteria:

1. Unresectable melanoma
2. Predisposing conditions for infertility
3. Early menopause or family history of early ovarian failure (idiopathic, \< 45 years)
4. Previous bilateral ovariectomy or other ovarian surgery
5. Personal history of autoimmune diseases, endocrine disorders (except for hypothyroidism)
6. Personal history of severe mental disorders associated with infertility (e.g., nervous anorexia) and/or requiring treatments that could impair fertility
7. Inability to give written informed consent.

Where it's running

• Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica.
  Perugia, Italy Recruiting
• Ospedale Oncologico "Giovanni Paolo II"
  Bari, Italy Not yet recruiting
• IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2
  Genova, Italy Not yet recruiting
• Fondazione IRCCS Istituto Nazionale dei Tumori
  Milan, Italy Not yet recruiting
• Azienda Ospedaliero-Universitaria, Modena
  Modena, Italy Not yet recruiting
• Istituto Nazionale Tumori "Fondazione Pascale"
  Naples, Italy Not yet recruiting

Study contacts

• Study coordinator: Mario Mandalà
• Email: mario.mandala@unipg.it
• Phone: 0039 0755784211

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.