NCT03416933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 27, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2022

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

4.1 years

First QC Date

January 18, 2018

Last Update Submit

August 3, 2023

Conditions

Melanoma (Skin)

Keywords

ctDNAMAPK inhibitionBRAF(V600) mutated

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Biological

EXPERIMENTAL
Other: Blood sampling

Interventions

Blood samplingOTHER

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.

Biological

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Georges François Leclerc (CGFL)

Dijon, 21079, France

Location

Hôpital de Mercy

Thionville, 57 100, France

Location

CHRU Nancy

Vandœuvre-lès-Nancy, 54 511, France

Location

Institut de Cancérologie de Lorraine (ICL)

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Melanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Geoffrois Lionnel, MD

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 31, 2018

Study Start

April 27, 2018

Primary Completion

June 17, 2022

Study Completion

June 17, 2022

Last Updated

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)