MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dabrafenib + Trametinib, Pembrolizumab, Nivolumab, Observation.
- Who it may be relevant to
- Registry conditions: Melanoma, Fertility. Basic parameters: up to 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse. A Prospective Multicenter Observational Study
Overview
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.
Interventions
- Drug Dabrafenib + Trametinib
There is no different use in the clinical application of the drugs reported above, the study on fertility will be implemented in the women with completely resected melanoma enrolled in the study - Drug Pembrolizumab
There is no different use in the clinical application of the drugs reported above, the study on fertility will be implemented in the women with completely resected melanoma enrolled in the study - Drug Nivolumab
There is no different use in the clinical application of the drugs reported above, the study on fertility will be implemented in the women with completely resected melanoma enrolled in the study - Other Observation
Patients who will not initiate adjuvant therapy, but will undergo observation (due to refusal, comorbidities, other reasons).
Primary outcome measures
- serum antimullerian hormone (AMH) [Time frame: 18 months after the start of therapy]
Secondary outcome measures (1)
- To assess long-term fertility preservation after completion of adjuvant therapy To assess the early impact on fertilitY preservation of a short course of therapy [Time frame: • AMH at 3 months after the start of adjuvant therapy • AMH at 12 months after the start of adjuvant therapy]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Unresectable melanoma
- Predisposing conditions for infertility
- Early menopause or family history of early ovarian failure (idiopathic, < 45 years)
- Previous bilateral ovariectomy or other ovarian surgery
- 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
- Inability to give written informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 10 centers
- Ospedale Oncologico "Giovanni Paolo II" — Bari
- IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2 — Genova
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
- Azienda Ospedaliero-Universitaria, Modena — Modena
- Istituto Nazionale Tumori "Fondazione Pascale" — Naples
- IOV Istituto Oncologico Veneto — Padova
- Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica. — Perugia
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
- … and 2 more centers
Identifiers
NCT: NCT07092670 · MELAFERT