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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04039672
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
27
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Skin biopsy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAF Inhibitors/MEK Inhibitors (BRAFi/MEKi) in BRAF Mutated Melanoma
Actual Study Start Date :
Nov 10, 2020
Anticipated Primary Completion Date :
Feb 10, 2023
Anticipated Study Completion Date :
Feb 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biopsy

Skin biopsy before BRAFi/MEKi treatment

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

Outcome Measures

Primary Outcome Measures

  1. Grafted avian embryo development [2 days post graft]

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

  2. Grafted avian embryo viability [2 days post graft]

    Survival rate of grafted embryo

Secondary Outcome Measures

  1. 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

  2. BRAFi maximum toxic effect dose in avian embryon [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 [3 months post treatment administration]

    weight of avian embryo after treatment injections in different concentrations

  4. BRAFi maximum toxic effect dose in avian embryo [3 months post treatment administration]

    Height of avian embryo after treatment injections in different concentrations

  5. MEKi maximum toxic effect dose in avian embryo [3 months post treatment administration]

    Height of avian embryo after treatment injections in different concentrations

  6. BRAFi maximum toxic effect dose in avian embryo [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 [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 [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 [3 months post treatment administration]

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

  10. Patient treatment response [3 months post inclusion]

    RECIST 1.1 response

  11. 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

  12. Embryo treatment response (metastasis) [2 days post graft]

    Metastasis appearance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de Dermatologie, Centre hospitalier Lyon Sud, HCL Pierre-Bénite France 69495

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04039672
Other Study ID Numbers:
  • 69HCL19_0248
First Posted:
Jul 31, 2019
Last Update Posted:
Jul 9, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Melanoma
Avian embryo
Additional relevant MeSH terms:
Melanoma

Study Results

No Results Posted as of Jul 9, 2021