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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03416933
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : August 9, 2018
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
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 : April 27, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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.

Primary Outcome Measures :
  1. Link between the presence of circulating tumor DNA and plasma concentrations of kinase inhibitors n patient with advanced BRAF(V600) mutated melanoma [ Time Frame: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03416933

Contact: MERLIN JEAN LOUIS, PharmaD +33 3 83 59 83 07
Contact: FERNANDES LAURINDA +33 3 83 59 84 87

Hôpital de Mercy Not yet recruiting
Ars-Laquenexy, France, 57 245
Contact: Truchetet François, MD         
Contact: Muller Philippe Co-, MD         
CHRU Nancy Recruiting
Vandœuvre-lès-Nancy, France, 54 511
Contact: Granel-Brocard Florence, MD         
Contact: Schmutz Jean-Luc, MD         
Institut de Cancérologie de Lorraine (ICL) Recruiting
Vandœuvre-lès-Nancy, France
Contact: Geoffrois Lionnel, MD   
Contact: Harlé Alexandre, PharmaD   
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Principal Investigator: Geoffrois Lionnel, MD Institut de Cancérologie de Lorraine

Responsible Party: Institut de Cancérologie de Lorraine Identifier: NCT03416933     History of Changes
Other Study ID Numbers: 2018-A00469-46
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut de Cancérologie de Lorraine:
MAPK inhibition
BRAF(V600) mutated

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas