Actively Recruiting
MELAFERT: Impact of Adjuvant Therapy on Fertility in Patients With Resected Melanoma at High Risk of Relapse A Prospective Multicenter Observational Study
Led by Intergruppo Melanoma Italiano · Updated on 2025-09-05
270
Participants Needed
10
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Melanoma survivorship among women of reproductive age is increasing due to more effective treatments. This research aims to understand how newer melanoma therapies, specifically MAP kinase pathway inhibitors and immune-checkpoint inhibitors (ICIs), affect fertility and ovarian function. The study responds to limited data about the impact of these treatments on reproductive health, focusing on women with resected melanoma at high risk of relapse. Participants will be observed in three groups: those receiving BRAF/MEK inhibitors (Dabrafenib plus Trametinib), those receiving ICIs such as Pembrolizumab or Nivolumab, and those under observation without adjuvant therapy. The treatments are used as per standard clinical practice, and the study monitors fertility outcomes without altering the clinical application of these drugs. Women enrolled will be followed over time with blood tests measuring serum antimullerian hormone (AMH) at 3, 12, and 18 months after starting therapy to assess ovarian reserve and fertility preservation. The study evaluates both early and long-term effects of adjuvant treatments on fertility. Participants' reproductive outcomes will be closely monitored during this prospective observational study conducted by Intergruppo Melanoma Italiano.
CONDITIONS
Brief 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
- Stage II, III, or IV melanoma that has been completely removed
- No prior 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 ovarian removal or other ovarian surgeries
- Personal history of autoimmune diseases or endocrine disorders except hypothyroidism
- Severe mental disorders linked to infertility or treatments that impair fertility
- Unable to provide written informed consent or refusal to consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants receive adjuvant therapy with BRAF/MEK inhibitors or Anti-PD-1 drugs, or undergo observation if they do not receive adjuvant therapy.
Visits at approximately 3, 12, and 18 months after the start of therapy
Duration - Up to 18 months after treatment start
Participants are monitored to assess long-term fertility preservation after completion of adjuvant therapy or observation.
Visits at approximately 3, 12, and 18 months after the start of therapy
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
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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