Status:
COMPLETED
Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma
Lead Sponsor:
Institut de Cancérologie de Lorraine
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03416933
Start Date
April 27 2018
End Date
June 17 2022
Last Update
August 4 2023
Active Locations (4)
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1
Centre Georges François Leclerc (CGFL)
Dijon, France, 21079
2
Hôpital de Mercy
Thionville, France, 57 100
3
CHRU Nancy
Vandœuvre-lès-Nancy, France, 54 511
4
Institut de Cancérologie de Lorraine (ICL)
Vandœuvre-lès-Nancy, France