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

Inclusion Criteria5

  • 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 Criteria7

  • 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.

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"

Napoli, Italy

IOV Istituto Oncologico Veneto

Padua, 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

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NCT07092670


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