MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.
1 other identifier
observational
270
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2025
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2025
CompletedFirst Posted
Study publicly available on registry
July 30, 2025
CompletedStudy Start
First participant enrolled
August 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2032
September 5, 2025
September 1, 2025
3 years
July 22, 2025
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum antimullerian hormone (AMH)
To evaluate, in women of childbearing age, the variation in ovarian reserve after completion of adjuvant therapy with BRAF/MEK inhibitors or anti-PD-1 agents
18 months after the start of therapy
Secondary Outcomes (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
• AMH at 3 months after the start of adjuvant therapy • AMH at 12 months after the start of adjuvant therapy
Study Arms (3)
Cohort A
BRAF/MEK inhibitors
Cohort B
Anti-PD-1
Cohort C
Observation arm
Interventions
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
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
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
Patients who will not initiate adjuvant therapy, but will undergo observation (due to refusal, comorbidities, other reasons).
Eligibility Criteria
Reproductive-age female patients with completely resected stage II, III, IV melanoma, irrespective of BRAF mutational status, with no previous history of chemo, radiation therapy and/or ovarian surgery.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ospedale Oncologico "Giovanni Paolo II"
Bari, 70122, Italy
IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2
Genova, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20861, Italy
Azienda Ospedaliero-Universitaria, Modena
Modena, 41125, Italy
Istituto Nazionale Tumori "Fondazione Pascale"
Napoli, 80016, Italy
IOV Istituto Oncologico Veneto
Padua, 35128, Italy
Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica.
Perugia, 06132, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Università degli Studi di Siena - U.O.C. Immunoterapia Oncologica Azienda Ospedaliera Universitaria Senese
Siena, 53035, Italy
Università di Torino - Clinica Dermatologica
Torino, 10126, Italy
Biospecimen
Serum antimullerian hormone (AMH), Follicle Stimulating Hormone (FSH), 5-beta oestradiol
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2025
First Posted
July 30, 2025
Study Start
August 4, 2025
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2032
Last Updated
September 5, 2025
Record last verified: 2025-09