RecruitingNCT07092670

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

MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse. A Prospective Multicenter Observational Study


Sponsor

Intergruppo Melanoma Italiano

Enrollment

270 participants

Start Date

Aug 4, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how treatments for melanoma (skin cancer) affect the fertility of young women who have had their cancer surgically removed. Researchers want to understand whether adjuvant (follow-up) therapy changes a woman's ability to have children in the future. **You may be eligible if...** - You are female and under 40 years old - You have had stage II, III, or IV melanoma that was completely removed by surgery - You have not previously received chemotherapy or radiation therapy **You may NOT be eligible if...** - Your melanoma cannot be fully removed by surgery - You already have conditions that affect your fertility - You went through early menopause (before age 45) or have a family history of early ovarian failure - You have had surgery that removed one or both ovaries - You have a history of autoimmune diseases or certain hormonal disorders (thyroid conditions are OK) - You have had severe mental health conditions linked to fertility problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDabrafenib + 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

DRUGPembrolizumab

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

DRUGNivolumab

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

OTHERObservation

Patients who will not initiate adjuvant therapy, but will undergo observation (due to refusal, comorbidities, other reasons).


Locations(10)

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

Università degli Studi di Siena - U.O.C. Immunoterapia Oncologica Azienda Ospedaliera Universitaria Senese

Siena, Italy

Università di Torino - Clinica Dermatologica

Torino, Italy

View Full Details on ClinicalTrials.gov

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NCT07092670


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