Melanoma
Conditions
Keywords
Melanoma, Avian embryo
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.
Interventions
PROCEDURESkin biopsy
5mm skin metastasis or primary melanoma biopsy
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grafted avian embryo development | 2 days post graft | Number of grafted embryo which develop tumor measurable by 3D microscopy |
| Grafted avian embryo viability | 2 days post graft | Survival rate of grafted embryo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MEKi maximum toxic effect dose in avian embryo | 3 months post treatment administration | weight of avian embryo after treatment injections in different concentrations |
| BRAFi maximum toxic effect dose in avian embryo | 3 months post treatment administration | Height of avian embryo after treatment injections in different concentrations |
| BRAFi/MEKi maximum toxic effect dose in avian embryo | 3 months post treatment administration | Survival rate in avian embryo after treatment injections in different concentrations |
| Embryo treatment response (tumor) | 2 days post graft | Embryo tumor volume obtained by confocal microscopy before treatment administration compared with tumor volume of non-treated embryo |
| Embryo treatment response (metastasis) | 2 days post graft | Metastasis appearance |
| Patient treatment response | 3 months post inclusion | RECIST 1.1 response |
| BRAFi maximum toxic effect dose in avian embryon | 3 months post treatment administration | Survival rate in avian embryo after treatment injections in different concentrations |
Countries
France
Outcome results
None listed