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CompletedNCT03416933OPTIMELUpdated Aug 4, 2023

Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma

An interventional study of Blood sampling in Melanoma (Skin), sponsored by Institut de Cancérologie de Lorraine. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-04.

Sponsored by Institut de Cancérologie de Lorraine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Melanoma (Skin)

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Keywords

  • ctDNA
  • MAPK inhibition
  • BRAF(V600) mutated
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Biological

    Other: Blood sampling

Interventions

  • OtherBlood 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.

05

What researchers measure

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

    Time frame: 1 day

06

Study locations

4 sites
  • Centre Georges François Leclerc (CGFL)
    Dijon, 21079, France
  • Hôpital de Mercy
    Thionville, 57 100, France
  • CHRU Nancy
    Vandœuvre-lès-Nancy, 54 511, France
  • Institut de Cancérologie de Lorraine (ICL)
    Vandœuvre-lès-Nancy, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03416933
Lead sponsor
Institut de Cancérologie de Lorraine
Responsible party
Sponsor
First posted
Jan 31, 2018
Start date
Apr 27, 2018
Primary completion
Jun 17, 2022
Completion
Jun 17, 2022
Last update
Aug 4, 2023

Study contacts

Geoffrois Lionnel, MD
principal investigator · Institut de Cancérologie de Lorraine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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