Actively Recruiting
MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.
Led by Intergruppo Melanoma Italiano · Updated on 2025-09-05
270
Participants Needed
10
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- Under 40 years of age
- Diagnosis of stage II, III, or IV melanoma that has been completely removed
- No previous chemotherapy or radiotherapy treatment
- Able to provide written informed consent
You will not qualify if you...
- Unresectable melanoma
- Conditions that increase risk of infertility
- Early menopause or family history of early ovarian failure (before age 45)
- Previous bilateral ovariectomy or other ovarian surgery
- History of autoimmune diseases or endocrine disorders except hypothyroidism
- History of severe mental disorders linked to infertility or treatments that might affect fertility
- Unable to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Ospedale Oncologico "Giovanni Paolo II"
Bari, Italy, 70122
Not Yet Recruiting
2
IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2
Genova, Italy
Not Yet Recruiting
3
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20861
Not Yet Recruiting
4
Azienda Ospedaliero-Universitaria, Modena
Modena, Italy, 41125
Not Yet Recruiting
5
Istituto Nazionale Tumori "Fondazione Pascale"
Naples, Italy, 80016
Not Yet Recruiting
6
IOV Istituto Oncologico Veneto
Padova, Italy, 35128
Not Yet Recruiting
7
Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica.
Perugia, Italy, 06132
Actively Recruiting
8
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Not Yet Recruiting
9
Università degli Studi di Siena - U.O.C. Immunoterapia Oncologica Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53035
Not Yet Recruiting
10
Università di Torino - Clinica Dermatologica
Torino, Italy, 10126
Not Yet Recruiting
Research Team
M
Mario Mandalà
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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