Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAFi/MEKi in BRAF Mutated Melanoma

Hospices Civils de Lyon10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Melanoma

Interventions

Skin biopsyPROCEDURE

5mm skin metastasis or primary melanoma biopsy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service de Dermatologie, Centre hospitalier Lyon Sud, HCL

Pierre-Bénite, France

Outcomes

Primary Outcomes

Grafted avian embryo development

Number of grafted embryo which develop tumor measurable by 3D microscopy

Time frame: 2 days post graft

Grafted avian embryo viability

Survival rate of grafted embryo

Time frame: 2 days post graft