Melanoma, Fertility
Conditions
Keywords
MELANOMA, fertility, skin cancer
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.
Interventions
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
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).
Sponsors
Intergruppo Melanoma Italiano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Stage II, III, IV completely resected melanoma 2. Female sex 3. Under 40 years of age 4. Not previously treated with chemotherapy and/or radiotherapy 5. Being able to give written informed consent.
Exclusion criteria
1. Unresectable melanoma 2. Predisposing conditions for infertility 3. Early menopause or family history of early ovarian failure (idiopathic, \< 45 years) 4. Previous bilateral ovariectomy or other ovarian surgery 5. Personal history of autoimmune diseases, endocrine disorders (except for hypothyroidism) 6. Personal history of severe mental disorders associated with infertility (e.g., nervous anorexia) and/or requiring treatments that could impair fertility 7. Inability to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum antimullerian hormone (AMH) | 18 months after the start of therapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
Italy
Contacts
Primary ContactMario Mandalà
Outcome results
None listed