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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-04

Study Completion Date

2032-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma Fertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

BRAF/MEK inhibitors

Dabrafenib + Trametinib

Intervention Type 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

Cohort B

Anti-PD-1

Pembrolizumab

Intervention Type 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

Intervention Type 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

Cohort C

Observation arm

Observation

Intervention Type OTHER

Patients who will not initiate adjuvant therapy, but will undergo observation (due to refusal, comorbidities, other reasons).

Interventions

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Dabrafenib + Trametinib

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

Intervention Type DRUG

Pembrolizumab

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

Intervention Type DRUG

Nivolumab

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

Intervention Type DRUG

Observation

Patients who will not initiate adjuvant therapy, but will undergo observation (due to refusal, comorbidities, other reasons).

Intervention Type OTHER

Eligibility Criteria

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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.

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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