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NCT Number: NCT04039672

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Dermatologie, Centre hospitalier Lyon Sud, HCL

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

skin biopsy

Procedure

5mm skin metastasis or primary melanoma biopsy

Primary outcomes

  1. Grafted avian embryo development

    Time frame: 2 days post graft

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

  2. Grafted avian embryo viability

    Time frame: 2 days post graft

    Survival rate of grafted embryo

Secondary outcomes

  1. BRAFi/MEKi maximum toxic effect dose in avian embryo

    Time frame: 3 months post treatment administration

    Survival rate in avian embryo after treatment injections in different concentrations

  2. BRAFi maximum toxic effect dose in avian embryon

    Time frame: 3 months post treatment administration

    Survival rate in avian embryo after treatment injections in different concentrations

  3. MEKi maximum toxic effect dose in avian embryo

    Time frame: 3 months post treatment administration

    weight of avian embryo after treatment injections in different concentrations

  4. BRAFi maximum toxic effect dose in avian embryo

    Time frame: 3 months post treatment administration

    Height of avian embryo after treatment injections in different concentrations

  5. MEKi maximum toxic effect dose in avian embryo

    Time frame: 3 months post treatment administration

    Height of avian embryo after treatment injections in different concentrations

  6. BRAFi maximum toxic effect dose in avian embryo

    Time frame: 3 months post treatment administration

    Presence of cardiac malformation in avian embryo after treatment injections in different concentrations

  7. MEKi maximum toxic effect dose in avian embryo

    Time frame: 3 months post treatment administration

    Presence of cardiac malformation in avian embryo after treatment injections in different concentrations

  8. BRAFi maximum toxic effect dose in avian embryo

    Time frame: 3 months post treatment administration

    Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations

  9. MEKi maximum toxic effect dose in avian embryo

    Time frame: 3 months post treatment administration

    Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations

  10. Patient treatment response

    Time frame: 3 months post inclusion

    RECIST 1.1 response

  11. Embryo treatment response (tumor)

    Time frame: 2 days post graft

    Embryo tumor volume obtained by confocal microscopy before treatment administration compared with tumor volume of non-treated embryo

  12. Embryo treatment response (metastasis)

    Time frame: 2 days post graft

    Metastasis appearance

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: MELANOPREDICT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 31, 2019
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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