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MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.

Recruitingn/aAges any - 40 YearsFemaleIntergruppo Melanoma Italiano
NCT07092670 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 d

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📋 Eligibility rules (as published)
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.
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What it tests

  • Dabrafenib + Trametinib
  • Pembrolizumab
  • Nivolumab
  • Observation
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Where

10 sites
Ospedale Oncologico "Giovanni Paolo II"
Bari, Italy
IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2
Genova, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Azienda Ospedaliero-Universitaria, Modena
Modena, Italy
Istituto Nazionale Tumori "Fondazione Pascale"
Naples, Italy
IOV Istituto Oncologico Veneto
Padova, Italy
Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica.
Perugia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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