Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma (OPTIMEL)

Institut de Cancérologie de Lorraine

Status

Completed

Conditions

Melanoma (Skin)

Treatments

Other: Blood sampling

Study type

Interventional

Funder types

Other

Identifiers

NCT03416933

2018-A00469-46

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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