OPTIMEL: Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma

Sponsor

Institut de Cancérologie de Lorraine (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03416933

Collaborator

(none)

Enrollment

Locations

Arm

53.2

Anticipated Duration (Months)

8.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Other: Blood sampling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Apr 27, 2018

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biological	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.

Arm

Intervention/Treatment

Experimental: Biological

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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

Sponsors and Collaborators

Institut de Cancérologie de Lorraine

Investigators

Principal Investigator: Geoffrois Lionnel, MD, Institut de Cancérologie de Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut de Cancérologie de Lorraine

ClinicalTrials.gov Identifier:

NCT03416933

Other Study ID Numbers:

2018-A00469-46

First Posted:

Jan 31, 2018

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut de Cancérologie de Lorraine

ctDNA

MAPK inhibition

BRAF(V600) mutated

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Mar 31, 2022