Clinical trial Recruiting at 1 site Observational Ages 18 and up

Monitoring the effects of encorafenib and binimetinib in melanoma treatment

Official title: Real-life Pharmacological Monitoring of Encorafenib-Binimetinib in the Treatment of Metastatic Melanoma

Run by Assistance Publique - Hôpitaux de Paris · NCT06774989 · Data updated 2026-11-12

This study is testing how the levels of two melanoma drugs, encorafenib and binimetinib, affect side effects and treatment success in adults with a specific type of advanced melanoma.

More Melanoma (Skin) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment66 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Drugs / interventionsbinimetinib, nivolumab, pembrolizumab, ipilimumab, trametinib, cobimetinib, immunotherapy
Locations1 site (Boulogne-Billancourt)
StatusRecruiting
StartedJanuary 2, 2025
Main results expectedJanuary 2028
Study endsJanuary 2028
Registry record updatedMarch 18, 2025
Trial IDNCT06774989 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with histologically confirmed advanced BRAFV600-mutant melanoma receiving encorafenib and/or binimetinib.

Probably not a fit

Patients with non-BRAFV600-mutant melanoma or those not receiving encorafenib and binimetinib will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the relationship between plasma levels of encorafenib and binimetinib and the occurrence of dose-limiting toxicities in adult patients with BRAFV600-mutant metastatic melanoma. Participants will be those receiving these targeted therapies, either in combination or alone, during their treatment. The study will take place across five dermatology departments in Paris, where patients will be monitored for adverse effects and treatment efficacy over the first three months. The findings could provide valuable insights into optimizing treatment regimens for better patient outcomes.

Why it matters

Potential benefit: If successful, this study could lead to improved management of treatment-related toxicities in melanoma patients, enhancing their quality of life and treatment efficacy.

How similar studies have gone: While studies on other BRAF and MEK inhibitors have shown success, this specific approach to monitoring encorafenib and binimetinib exposure is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Adults ≥ 18 years of age

* Histologically confirmed advanced melanoma, stage III/stage IV inoperable (primary cutaneous, mucosal or unknown)
* Treatment with encorafenib and/or binimetinib, whatever the line of treatment, for curative purposes.
* Affiliated to a social security scheme or beneficiary of such a scheme
* informed and non-opposition collected.

Exclusion Criteria:

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Where it's running

  • Department of Oncology-Dermatology, Ambroise Paré Hospital - APHP
    Boulogne-Billancourt, France
    Recruiting

Study contacts

  • Principal investigator: Elisa FUNCK-BRETANO, MD, PhD — Department of Oncology-Dermatology, Ambroise Paré Hospital - APHP
  • Study coordinator: Elisa FUNCK-BRENTANO, MD, PhD
  • Email: elisa.funck-brentano@aphp.fr
  • Phone: + 33171167721

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.