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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other, Drug
Study Type: Observational
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
Participation Requirements
Sex: Female
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Ospedale Oncologico Giovanni Paolo II
NOT_YET_RECRUITING
Bari
IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2
NOT_YET_RECRUITING
Genova
Fondazione IRCCS Istituto Nazionale dei Tumori
NOT_YET_RECRUITING
Milan
Azienda Ospedaliero-Universitaria, Modena
NOT_YET_RECRUITING
Modena
Istituto Nazionale Tumori Fondazione Pascale
NOT_YET_RECRUITING
Naples
IOV Istituto Oncologico Veneto
NOT_YET_RECRUITING
Padova
Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica.
RECRUITING
Perugia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NOT_YET_RECRUITING
Roma
Università degli Studi di Siena - U.O.C. Immunoterapia Oncologica Azienda Ospedaliera Universitaria Senese
NOT_YET_RECRUITING
Siena
Università di Torino - Clinica Dermatologica
NOT_YET_RECRUITING
Torino
Contact Information
Primary
Mario Mandalà
mario.mandala@unipg.it
0039 0755784211
Time Frame
Start Date: 2025-08-04
Estimated Completion Date: 2032-08
Participants
Target number of participants: 270
Treatments
Cohort A
BRAF/MEK inhibitors
Cohort B
Anti-PD-1
Cohort C
Observation arm
Related Therapeutic Areas
Sponsors
Leads: Intergruppo Melanoma Italiano

This content was sourced from clinicaltrials.gov