Monitoring the effects of encorafenib and binimetinib in melanoma treatment
Real-life Pharmacological Monitoring of Encorafenib-Binimetinib in the Treatment of Metastatic Melanoma
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 |
|---|---|
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | binimetinib, nivolumab, pembrolizumab, ipilimumab, trametinib, cobimetinib, immunotherapy |
| Locations | 1 site (Boulogne-Billancourt) |
| Trial ID | NCT06774989 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced BRAFV600-mutant melanoma receiving encorafenib and/or binimetinib.
Not a fit: Patients with non-BRAFV600-mutant melanoma or those not receiving encorafenib and binimetinib will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boulogne-Billancourt
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.