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Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma

NCT03416933 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-08-04

No results posted yet for this study

Summary

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

  • Melanoma (Skin)

Interventions

OTHER

Blood sampling

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.

Sponsors & Collaborators

  • Institut de Cancérologie de Lorraine

    lead OTHER

Principal Investigators

  • Geoffrois Lionnel, MD · Institut de Cancérologie de Lorraine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2022-06-17
Completion
2022-06-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03416933 on ClinicalTrials.gov