Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma

Melanoma (Skin) Clinical Trial

— OPTIMEL  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416933
• Other study ID #: 2018-A00469-46
• Status: Completed
• Phase: N/A
• Start date: April 27, 2018
• Est. completion date: June 17, 2022

Study information

• Verified date: August 2023
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

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.

Locations

Country	Name	City	State
France	Centre Georges François Leclerc (CGFL)	Dijon
France	Hôpital de Mercy	Thionville
France	CHRU Nancy	Vandœuvre-lès-Nancy
France	Institut de Cancérologie de Lorraine (ICL)	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Link between the presence of circulating tumor DNA and plasma concentrations of kinase inhibitors n patient with advanced BRAF(V600) mutated melanoma	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	1 day