Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07092670

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Melanoma Fertility Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

Up to 40 year

Sex eligibility

Female

Study type

Observational

Primary location

Ospedale Oncologico "Giovanni Paolo II", Bari, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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).

Primary outcomes

  1. serum antimullerian hormone (AMH)

    Time frame: 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 outcomes

  1. 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

    Time frame: • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mario Mandalà

CONTACT

[email protected]

0039 0755784211

Sponsors and collaborators

Lead sponsor

Intergruppo Melanoma Italiano

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2032
First posted
Jul 30, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.