BRAF V600-mutant metastatic melanoma are commonly treated using a combination of anti-BRAF and anti-MEK tyrosine kinase inhibitors (TKIs). The OPTIMEL trial aims to study the interest of therapeutic drug monitoring (TDM) of TKIs and circulating tumor DNA (ctDNA) detected in plasma of patients with metastatic melanoma for disease monitoring. 35 patients with metastatic melanoma and treated with dabrafenib and trametinib will be enrolled in this trial. Blood samples will be collected for the determination of TKIs concentration and ctDNA detection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
35
2x10 ml of patient peripherical blood will be collected at D0, D15, D30, D90, D180, D270 and with progression or at the end of the follow-up at the 12th month.
Centre Georges François Leclerc (CGFL)
Dijon, France
Hôpital de Mercy
Thionville, France
CHRU Nancy
Vandœuvre-lès-Nancy, France
Institut de Cancérologie de Lorraine (ICL)
Vandœuvre-lès-Nancy, France
Link between the presence of circulating tumor DNA and plasma concentrations of kinase inhibitors n patient with advanced BRAF(V600) mutated melanoma
ctDNA in patient with advanced BRAF(V600) mutated melanoma is estimated by the ratio of the Ct of the sample to the control. Plasma concentrations of anti-BRAF and anti-MEK tyrosine kinase inhibitors are expressed in μg / mL
Time frame: 1 day
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