Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-27

Study Completion Date

2022-06-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma (Skin)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Biological

Group Type EXPERIMENTAL

Blood sampling

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No