Clinical trial NCT04039672: Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAFi/MEKi in BRAF Mutated Melanoma
Official title: Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAF Inhibitors/MEK Inhibitors (BRAFi/MEKi) in BRAF Mutated Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Keywords: Melanoma
Avian embryo
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an interventional mono-centric study in patients with BRAF mutated metastatic melanoma treated with BRAF/MEK inhibitors. The aim of the study is to test the grafting of patient tumoral cells in avian embryo and develop a predictive in vivo model for patient treatment response.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 years
* Signed written informed consent
* Patient with BRAF V600 mutated metastatic or unresectable melanoma histologically confirmed
* BRAFi/MEKi treatment indication
* Patient with skin tumor (excluded face and skinfold) available for biopsy
* Measurable disease as defined by RECIST v1.1 criteria
* Patient affiliated to or a beneficiary of a social security category

Exclusion Criteria:

* Ocular melanoma
* Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
* Pregnant or nursing (lactating) women
* Patients protected by law

Primary outcomes:
measure: Grafted avian embryo development
timeFrame: 2 days post graft
measure: Grafted avian embryo viability
timeFrame: 2 days post graft
Secondary outcomes:
measure: BRAFi/MEKi maximum toxic effect dose in avian embryo
timeFrame: 3 months post treatment administration
measure: BRAFi maximum toxic effect dose in avian embryon
timeFrame: 3 months post treatment administration
measure: MEKi maximum toxic effect dose in avian embryo
timeFrame: 3 months post treatment administration
measure: BRAFi maximum toxic effect dose in avian embryo
timeFrame: 3 months post treatment administration
measure: MEKi maximum toxic effect dose in avian embryo
timeFrame: 3 months post treatment administration
measure: BRAFi maximum toxic effect dose in avian embryo
timeFrame: 3 months post treatment administration
measure: MEKi maximum toxic effect dose in avian embryo
timeFrame: 3 months post treatment administration
measure: BRAFi maximum toxic effect dose in avian embryo
timeFrame: 3 months post treatment administration
measure: MEKi maximum toxic effect dose in avian embryo
timeFrame: 3 months post treatment administration
measure: Patient treatment response
timeFrame: 3 months post inclusion
measure: Embryo treatment response (tumor)
timeFrame: 2 days post graft
measure: Embryo treatment response (metastasis)
timeFrame: 2 days post graft
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de Dermatologie, Centre hospitalier Lyon Sud, HCL
Study officials:
References: