Studies how melanoma treatments after surgery may affect fertility in women
Follows women of childbearing age with melanoma who receive treatments after surgery.
Key facts
- Who runs it
- Intergruppo Melanoma Italiano
- Where
- Bari, Genova, Milan, Modena, Naples, Padova, Perugia, Roma, Siena, and Torino, ItalySee the 10 sites
- Trial code
- Registry title
- MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.
- Status
- Recruiting
- People taking part
- 270 people, planned
- Started
- 4 Aug 2025
- Expected to end
- Aug 2032
- Type of study
- Observational, 3 groups
- Treatments tested
- Dabrafenib + Trametinib
- Pembrolizumab
- Nivolumab
- Observation
- Record updated
- 5 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women under 40 whose melanoma has been completely removed by surgery. It studies how treatment after surgery affects fertility.
- Age
- Under 40 years
- Sex
- Women only
- Disease stage
- Stage II, III or IV melanoma that has been completely removed by surgery
- Earlier treatment
- Cannot have had chemotherapy or radiotherapy before
Main reasons for not taking part
- Melanoma that cannot be removed by surgery
- Conditions that make infertility more likely
- Early menopause, or early ovarian failure in the family (before age 45)
- Earlier removal of both ovaries or other ovarian surgery
- Autoimmune disease or endocrine disorder (hypothyroidism is allowed)
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Stage II, III, IV completely resected melanoma
- Female sex
- Under 40 years of age
- Not previously treated with chemotherapy and/or radiotherapy
- Being able to give written informed consent
Who cannot take part
- Previous bilateral ovariectomy or other ovarian surgery
- Predisposing conditions for infertility
- Personal history of autoimmune diseases, endocrine disorders (except for hypothyroidism)
- Personal history of severe mental disorders associated with infertility (e.g., nervous anorexia) and/or requiring treatments that could impair fertility
- Early menopause or family history of early ovarian failure (idiopathic, < 45 years)
- Unresectable melanoma
- Inability to give written informed consent
Where in Italy
- Ospedale Oncologico "Giovanni Paolo II"Bari, ItalyContact: Michele GuidaNot yet recruiting
- IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2Genova, ItalyContact: Francesco SpagnoloNot yet recruiting
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyContact: Lorenza Di GuardoNot yet recruiting
- Azienda Ospedaliero Universitaria ModenaModena, ItalyContact: Roberta DepenniNot yet recruiting
- Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyContact: Paolo Antonio AsciertoNot yet recruiting
- IOV Istituto Oncologico VenetoPadova, ItalyContact: Jacopo PigozzoNot yet recruiting
- Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica.Perugia, ItalyContact: Mario MandalàTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyContact: Ernesto RossiNot yet recruiting
- Università degli Studi di Siena - U.O.C. Immunoterapia Oncologica Azienda Ospedaliera Universitaria SeneseSiena, ItalyContact: Anna Maria Di GiacomoNot yet recruiting
- Università di Torino - Clinica DermatologicaTorino, ItalyContact: Pietro QuaglinoNot yet recruiting
About the trial
What the trial wants to find out
Melanoma survivorship in reproductive-age women is increasing due to the advent of effective therapies in the curative setting. However, while the impact on fertility and ovarian function of chemotherapy agents is well known, there is still a lack of consistent data regarding novel the Mitogen-activated protein kinase (MAP) kinase pathway inhibitors and immune-checkpoint inhibitors (ICIs) used in melanoma.
Read full original descriptionShow less
A recent study showed that a single course of anti-PD-1 (PD, Programmed cell death protein 1) or anti-CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) reduced both the number and quality of oocytes in mice through an immune-mediated mechanism. In particular, primordial follicle damage cannot be restored, leading to relevant clinical implications.
The study aims to help to determine the impact of MAP kinase pathway inhibitors and ICIs on reproductive outcomes, and whether clinicians should discuss (and in what terms) fertility preservation techniques in reproductive-age women receiving ICIs and MAP kinase pathway inhibitors in the adjuvant setting.
The 3 groups in the trial
- Cohort A
BRAF/MEK inhibitors
Treatment: Dabrafenib + Trametinib
- Cohort B
Anti-PD-1
Treatment: Pembrolizumab and Nivolumab
- Cohort C
Observation arm
Treatment: Observation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse. A Prospective Multicenter Observational Study
- Plain-language title
- Studies how melanoma treatments after surgery may affect fertility in womenGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 September 2025