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NCT04039672 Clinical Trial

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

Melanoma Clinical Trial

— MELANOPREDICT  

Official title:
Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAF Inhibitors/MEK Inhibitors (BRAFi/MEKi) in BRAF Mutated Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04039672
Other study ID # 69HCL19_0248
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2, 2021
Est. completion date July 2, 2024

Study information
Verified date December 2023
Source Hospices Civils de Lyon
Contact Stéphane DALLE, MD, Prof.
Phone 478861679
Email stephane.dalle@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date July 2, 2024
Est. primary completion date July 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Skin biopsy
5mm skin metastasis or primary melanoma biopsy

Locations
Country Name City State
France Service de Dermatologie, Centre hospitalier Lyon Sud, HCL Pierre-Bénite

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Grafted avian embryo development Number of grafted embryo which develop tumor measurable by 3D microscopy 2 days post graft
Primary Grafted avian embryo viability Survival rate of grafted embryo 2 days post graft
Secondary BRAFi/MEKi maximum toxic effect dose in avian embryo Survival rate in avian embryo after treatment injections in different concentrations 3 months post treatment administration
Secondary BRAFi maximum toxic effect dose in avian embryon Survival rate in avian embryo after treatment injections in different concentrations 3 months post treatment administration
Secondary MEKi maximum toxic effect dose in avian embryo weight of avian embryo after treatment injections in different concentrations 3 months post treatment administration
Secondary BRAFi maximum toxic effect dose in avian embryo Height of avian embryo after treatment injections in different concentrations 3 months post treatment administration
Secondary MEKi maximum toxic effect dose in avian embryo Height of avian embryo after treatment injections in different concentrations 3 months post treatment administration
Secondary BRAFi maximum toxic effect dose in avian embryo Presence of cardiac malformation in avian embryo after treatment injections in different concentrations 3 months post treatment administration
Secondary MEKi maximum toxic effect dose in avian embryo Presence of cardiac malformation in avian embryo after treatment injections in different concentrations 3 months post treatment administration
Secondary BRAFi maximum toxic effect dose in avian embryo Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations 3 months post treatment administration
Secondary MEKi maximum toxic effect dose in avian embryo Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations 3 months post treatment administration
Secondary Patient treatment response RECIST 1.1 response 3 months post inclusion
Secondary Embryo treatment response (tumor) Embryo tumor volume obtained by confocal microscopy before treatment administration compared with tumor volume of non-treated embryo 2 days post graft
Secondary Embryo treatment response (metastasis) Metastasis appearance 2 days post graft
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