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.
Study Type
OBSERVATIONAL
Enrollment
270
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).
Ospedale Oncologico "Giovanni Paolo II"
Bari, Italy
NOT_YET_RECRUITINGIRCCS Ospedale Policlinico San Martino, Oncologia Medica 2
Genova, Italy
NOT_YET_RECRUITINGFondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
NOT_YET_RECRUITINGAzienda Ospedaliero-Universitaria, Modena
Modena, Italy
NOT_YET_RECRUITINGIstituto Nazionale Tumori "Fondazione Pascale"
Napoli, Italy
NOT_YET_RECRUITINGIOV Istituto Oncologico Veneto
Padua, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica.
Perugia, Italy
RECRUITINGFondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
NOT_YET_RECRUITINGUniversità degli Studi di Siena - U.O.C. Immunoterapia Oncologica Azienda Ospedaliera Universitaria Senese
Siena, Italy
NOT_YET_RECRUITINGUniversità di Torino - Clinica Dermatologica
Torino, Italy
NOT_YET_RECRUITINGserum 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
Time frame: 18 months after the start of therapy
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
correlation between baseline/post-treatment serum AMH and pregnancy rate correlation between baseline/post-treatment serum AMH and menstrual activity ratio between desired (Gd)/ obtained (Go) pregnancies other reproductive outcomes
Time frame: • AMH at 3 months after the start of adjuvant therapy • AMH at 12 months after the start of adjuvant therapy
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