Condition: Melanoma (Skin) · Sponsor: Assistance Publique - Hôpitaux de Paris
In recent years, the prognosis for BRAFV600E-mutant metastatic melanoma has been transformed with targeted therapies combining BRAF and MEK inhibitors (dabrafenib-trametinib and encorafenib-cobimetinib), which have improved progression-free survival and overall survival. However, adverse events are very frequent, and a significant proportion of patients progress secondarily. Several clinical studies have shown that inter-individual variability in plasma exposure to BRAF inhibitors (dabrafenib, vemurafenib) or MEK inhibitors (trametinib) may contribute in part to the occurrence of severe toxicities, and on the efficiency of the treatment. To our knowledge, no data are currently available on the exposure/toxicity relationship for encorafenib and binimetinib. The aim of this study is to assess the association between plasma exposure of encorafenib and binimetinib and the occurrence of dose-limiting toxicity during the first 3 months of treatment. Our secondary objectives are the identification of factors of variability in plasma exposure to encorafenib and binimetinib, the assessment of the exposure-response relationship to treatment (PFS, OS), the evaluation of the influence of the residual plasma concentration of checkpoint inhibiting antibodies (nivolumab, pembrolizumab, ipilimumab) in the first month on the occurrence of dose-limiting toxicity during treatment with encorafenib/binimetinib. Also, the investigators will study the relationship between the kinetics of circulat…
This description comes directly from the study's public registry record.
Elisa FUNCK-BRENTANO, MD, PhD · + 33171167721 · elisa.funck-brentano@aphp.fr
Sarah Bouchereau, MD · + 33149094442 · sarah.bouchereau@aphp.fr
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| Department of Oncology-Dermatology, Ambroise Paré Hospital - APHP | Boulogne-Billancourt, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06774989