Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma

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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Key information

Conditions

Melanoma (Skin) Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Georges François Leclerc (CGFL), Dijon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

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.

Primary outcomes

Link between the presence of circulating tumor DNA and plasma concentrations of kinase inhibitors n patient with advanced BRAF(V600) mutated melanoma

Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: OPTIMEL

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Jan 31, 2018
Registry last updated: Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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