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New study to reveal if modern melanoma drugs harm fertility

NCT ID NCT07092670

Knowledge-focused Sponsor: Intergruppo Melanoma Italiano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows 270 women under 40 who have had melanoma removed and are now taking adjuvant therapies like dabrafenib, trametinib, pembrolizumab, or nivolumab. Researchers will measure ovarian reserve using a blood test before and after treatment to see how these drugs affect fertility. The goal is to help doctors and patients decide whether to pursue fertility preservation before starting treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better understand which melanoma treatments affect fertility and guide women on whether to consider egg freezing before starting therapy.
What could go wrong
This is an observational study, not a treatment trial. It will not test new drugs or change outcomes. Results may take years and may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Aug 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Up to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

infertility disorder melanoma skin neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fertility Melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica.

    RECRUITING

    Perugia, 06132, Italy

  • Azienda Ospedaliero-Universitaria, Modena

    NOT_YET_RECRUITING

    Modena, 41125, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    NOT_YET_RECRUITING

    Milan, 20861, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    NOT_YET_RECRUITING

    Roma, 00168, Italy

  • IOV Istituto Oncologico Veneto

    NOT_YET_RECRUITING

    Padova, 35128, Italy

  • IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2

    NOT_YET_RECRUITING

    Genova, Italy

  • Istituto Nazionale Tumori "Fondazione Pascale"

    NOT_YET_RECRUITING

    Naples, 80016, Italy

  • Ospedale Oncologico "Giovanni Paolo II"

    NOT_YET_RECRUITING

    Bari, 70122, Italy

  • Università degli Studi di Siena - U.O.C. Immunoterapia Oncologica Azienda Ospedaliera Universitaria Senese

    NOT_YET_RECRUITING

    Siena, 53035, Italy

  • Università di Torino - Clinica Dermatologica

    NOT_YET_RECRUITING

    Torino, 10126, Italy

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