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

Sponsor
Intergruppo Melanoma Italiano
Study ID
NCT07092670
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib + Trametinib — DRUG
    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
  • Pembrolizumab — DRUG
    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
  • Nivolumab — DRUG
    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
  • Observation — OTHER
    Patients who will not initiate adjuvant therapy, but will undergo observation (due to refusal, comorbidities, other reasons).

Study Details

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.

Key Dates

Start date
Aug 4, 2025
Status verified
Sep 2025
Primary completion
Aug 1, 2028
Completion
Aug 31, 2032

Study Design

Enrollment
270 participants (estimated)

Arms

  • Arm: Cohort A
    BRAF/MEK inhibitors
  • Arm: Cohort B
    Anti-PD-1
  • Arm: Cohort C
    Observation arm

Primary Outcome Measure

serum antimullerian hormone (AMH) [ Time Frame: 18 months after the start of therapy ]

Central Contacts

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