MelanomaNCT07092670
MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.
An observational study of Melanoma and Fertility, run by Intergruppo Melanoma Italiano at 10 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- What is being tested?
- Dabrafenib + Trametinib, Pembrolizumab and Nivolumab
- How many people
- 270 participants
- Where
- 10 sitesItaly
- Study dates
- 4 Aug 2025to Aug 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Reproductive-age female patients with completely resected stage II, III, IV melanoma, irrespective of BRAF mutational status, with no previous history of chemo, radiation therapy and/or ovarian surgery.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Italy10 sites, 10 recruiting
- Not yet recruiting
Ospedale Oncologico "Giovanni Paolo II"
Bari, 70122
Michele Guida, 00390805555255, micguida57@gmail.com
- Not yet recruiting
IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2
Genova
Francesco Spagnolo, 00390105558104, francesco.spagnolo@hsanmartino.it
- Not yet recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20861
Lorenza Di Guardo, 00390223902469, Lorenza.DiGuardo@istitutotumori.mi.it
- Not yet recruiting
Azienda Ospedaliero-Universitaria, Modena
Modena, 41125
Roberta Depenni, 00390594222111, depenni.roberta@policlinico.mo.it
- Not yet recruiting
Istituto Nazionale Tumori "Fondazione Pascale"
Naples, 80016
Paolo Antonio Ascierto, 00390815903841, paolo.ascierto@gmail.com
- Not yet recruiting
IOV Istituto Oncologico Veneto
Padova, 35128
Jacopo Pigozzo, 00390498215938, jacopo.pigozzo@iov.veneto.it
- Recruiting
Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica.
Perugia, 06132
Mario Mandalà, 0039 0755784211, mario.mandala@unipg.it
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Ernesto Rossi, 00390630156318, ernesto.rossi@policlinicogemelli.it
- Not yet recruiting
Università degli Studi di Siena - U.O.C. Immunoterapia Oncologica Azienda Ospedaliera Universitaria Senese
Siena, 53035
Anna Maria Di Giacomo, 00390577586305, annamaria.digiacomo@unisi.it
- Not yet recruiting
Università di Torino - Clinica Dermatologica
Torino, 10126
Pietro Quaglino, 00390116335849, pietro.quaglino@unito.it
About this study
Official title: MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse. A Prospective Multicenter Observational Study
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.
- Being tested
- Dabrafenib + Trametinib, Pembrolizumab, Nivolumab, Observation
- Keywords
- MELANOMA, fertility, skin cancer
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabrafenib + TrametinibDrug
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
PembrolizumabDrug
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
NivolumabDrug
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
ObservationOther
Patients who will not initiate adjuvant therapy, but will undergo observation (due to refusal, comorbidities, other reasons).
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | BRAF/MEK inhibitors Receives: Drug: Dabrafenib + Trametinib | |
| Cohort B | Anti-PD-1 Receives: Drug: Pembrolizumab; Drug: Nivolumab | |
| Cohort C | Observation arm Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum antimullerian hormone (AMH)
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
Measured: 18 months after the start of therapy
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
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
Measured: • AMH at 3 months after the start of adjuvant therapy • AMH at 12 months after the start of adjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start4 Aug 2025
- Primary completion1 Aug 2028 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intergruppo Melanoma Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092670
- Sponsor's protocol ID
- MELAFERT
- Status last verified
- Sep 2025
- First submitted
- 22 Jul 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse. A Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT07092670
- Acronym / sponsor ID
- MELAFERT
- Keywords
- MELANOMA, fertility, skin cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Intergruppo Melanoma ItalianoUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: Dabrafenib + TrametinibBRAF/MEK inhibitors |
| Cohort B | – | Drug: Pembrolizumab, Drug: NivolumabAnti-PD-1 |
| Cohort C | – | Other: ObservationObservation arm |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Reproductive-age female patients with completely resected stage II, III, IV melanoma, irrespective of BRAF mutational status, with no previous history of chemo, radiation therapy and/or ovarian surgery.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabrafenib + TrametinibThere 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 | Drug | Cohort A |
| PembrolizumabThere 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 | Drug | Cohort B |
| NivolumabThere 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 | Drug | Cohort B |
| ObservationPatients who will not initiate adjuvant therapy, but will undergo observation (due to refusal, comorbidities, other reasons). | Other | Cohort C |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Fertility, run by Intergruppo Melanoma Italiano at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Mandalà (0039 0755784211, mario.mandala@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum antimullerian hormone (AMH) (time frame: 18 months after the start of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.