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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | binimetinib, nivolumab, pembrolizumab, ipilimumab, trametinib, cobimetinib, immunotherapy |
| Locations | 1 site (Boulogne-Billancourt) |
| Status | Recruiting |
| Started | January 2, 2025 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | March 18, 2025 |
| Trial ID | NCT06774989 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: \-
Where it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.