Clinical trial · Interventional
Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma
Therapeutic Drug Monitoring of Kinase Inhibitors and Study of Circulating Tumor DNA in Patients With Mutated BRAF Metastatic Cutaneous Melanoma and Treated With Anti-BRAF and Anti-MEK Kinase Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biological
- interventionNames
- Other: Blood sampling
Primary outcomes (1)
- measure
- Link between the presence of circulating tumor DNA and plasma concentrations of kinase inhibitors n patient with advanced BRAF(V600) mutated melanoma
- timeFrame
- 1 day
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women 18 years of age and older * Histologic proven advanced skin melanoma (Stage IV or stage IIIc inoperable) with BRAF V600 mutation * Patient who will treated with combined kinase inhibitors (dabrafenib + trametinib). * Patient able to stand a blood collection of 20 mL * Ability to provide an informed written consent form * Patient must be affiliated to a social security system * Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study. Exclusion Criteria: * Patient with mucosal melanoma * Patient with non-metastatic skin melanoma (All stages except stage IV and stage III C inoperable) * Patient with another synchronous cancer, or within 3 years * Patient with a contraindication to blood collection of 20 mL * Patient deprived of liberty or under supervision * Patient unable to receive kinase inhibitor therapy * Patient treated with another combined kinase inhibitors than dabrafenib and trametinib * Pregnant or breastfeeding women * Patient (man or woman) of childbearing age who does not agree to use of contraceptive methods validated during the study
References
Publications (0)
Data not yet available