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

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Melanoma (Skin) focused on measuring ctDNA, MAPK inhibition, BRAF(V600) mutated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Georges François Leclerc (CGFL)
  • Hôpital de Mercy
  • CHRU Nancy
  • Institut de Cancérologie de Lorraine (ICL)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biological

Arm Description

Outcomes

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
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

Secondary Outcome Measures

Full Information

First Posted
January 18, 2018
Last Updated
August 3, 2023
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT03416933
Brief Title
Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 27, 2018 (Actual)
Primary Completion Date
June 17, 2022 (Actual)
Study Completion Date
June 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
ctDNA, MAPK inhibition, BRAF(V600) mutated

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biological
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
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 Outcome Measure Information:
Title
Link between the presence of circulating tumor DNA and plasma concentrations of kinase inhibitors n patient with advanced BRAF(V600) mutated melanoma
Description
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
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrois Lionnel, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Georges François Leclerc (CGFL)
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital de Mercy
City
Thionville
ZIP/Postal Code
57 100
Country
France
Facility Name
CHRU Nancy
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54 511
Country
France
Facility Name
Institut de Cancérologie de Lorraine (ICL)
City
Vandœuvre-lès-Nancy
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma

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