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

Civil Hospices of Lyon

Status: Completed

Conditions: Melanoma

Treatments: Procedure: Skin biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04039672

69HCL19_0248

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Biopsy

Experimental group

Description:

Skin biopsy before BRAFi/MEKi treatment

Treatment:

Procedure: Skin biopsy