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

Recruitingn/aAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

1 site
Department of Oncology-Dermatology, Ambroise Paré Hospital - APHP
Boulogne-Billancourt, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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