Adjuvant melanoma treatments and fertility after surgery
MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse. A Prospective Multicenter Observational Study
Intergruppo Melanoma Italiano · NCT07092670
This project will test whether adjuvant immunotherapy or targeted MAPK inhibitor drugs affect fertility in women under 40 after melanoma surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | N/A to 40 Years |
| Sex | Female |
| Sponsor | Intergruppo Melanoma Italiano (other) |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Bari and 9 other locations) |
| Trial ID | NCT07092670 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women under 40 with completely resected stage II, III, or IV melanoma who have not had prior chemotherapy or radiotherapy and can give written informed consent are ideal candidates.
Not a fit: Patients with unresectable melanoma, known predisposing conditions for infertility, early menopause or family history of early ovarian failure, prior bilateral ovariectomy or other ovarian surgery, certain autoimmune or endocrine disorders, or inability to consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, results could help doctors better counsel young melanoma patients about fertility risks and when to offer fertility preservation options.
How similar studies have performed: Preclinical work in mice has shown that a single course of anti-PD-1 or anti-CTLA-4 can reduce oocyte number and quality, but clinical human data on ICIs and MAPK inhibitors affecting fertility remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bari and 9 other locations
- 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)
- IOV Istituto Oncologico Veneto — Padova, Italy (NOT_YET_RECRUITING)
- Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica. — Perugia, Italy (RECRUITING)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (NOT_YET_RECRUITING)
- Università degli Studi di Siena - U.O.C. Immunoterapia Oncologica Azienda Ospedaliera Universitaria Senese — Siena, Italy (NOT_YET_RECRUITING)
- Università di Torino - Clinica Dermatologica — Torino, Italy (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Mario Mandalà
- Email: mario.mandala@unipg.it
- Phone: 0039 0755784211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Melanoma, Fertility, MELANOMA, fertility, skin cancer