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

Not Applicable

Completed

• Conditions: Melanoma
• Interventions: Procedure: Skin biopsy

• Registration Number: NCT04039672
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Study Start: 2021-04-02
• Primary Completion: 2024-07-02
• Study Completion: 2024-07-02
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biopsy	Skin biopsy	Skin biopsy before BRAFi/MEKi treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
BRAFi maximum toxic effect dose in avian embryon	3 months post treatment administration	Survival rate in avian embryo after treatment injections in different concentrations
MEKi maximum toxic effect dose in avian embryo	3 months post treatment administration	Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations
BRAFi maximum toxic effect dose in avian embryo	3 months post treatment administration	Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations
Patient treatment response	3 months post inclusion	RECIST 1.1 response
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

Trial Locations

Locations (1)

Service de Dermatologie, Centre hospitalier Lyon Sud, HCL; 🇫🇷 Pierre-Bénite, France