Variations of Immune Infiltrate and Cell Plasticity Markers in Treated Metastatic Melanoma Patients
NCT ID: NCT05029791
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-08-18
2031-11-18
Brief Summary
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The objective is to study the variations of immune infiltrate and cell plasticity before and under immunotherapy or targeted therapy. Two biopsies are done before and one month after the treatment initiation and one blood sample is done after the treatment initiation.
100 patients will be included and followed during 5 years.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Metastatic melanoma
Patients with stage III or IV melanoma eligible for an immunotherapy or targeted therapy
Tumor biopsy
2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1)
Blood sample
1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1)
Interventions
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Tumor biopsy
2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1)
Blood sample
1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1)
Eligibility Criteria
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Inclusion Criteria
* Female patients must agree to the use of 2 methods of contraception. For man one method of contraception is needed if if his partner is in childbearing age throughout the study and for at least 5 months after last study treatment administration.
* Patients with metastatic stage III or IV melanoma relapse
* Eligible for a melanoma metastatic treatment indicated and administered as part of usual care
* Patients must be willing and able to undergo cutaneous tumor biopsies (except on the face and folds or lymph node) according to the study protocol
* Patient insured or beneficiary of a health insurance plan
* Patient able to provide informed consent and sign approved consent forms to participate in the study
* Patient accepting the conservation of biological samples and their use for clinical research including genetic research
Exclusion Criteria
* Patients with a documented history of autoimmune pathology
* Ocular melanoma
* Persons placed under the safeguard of justice
* Use of immunosuppressants including corticosteroids 4 weeks before the inclusion
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Service de dermatologie (Bâtiment 1A)
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Stéphane Dalle, Pr
Role: primary
Myrtille Le Bouar, Msc
Role: backup
Other Identifiers
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69HCL21_0906
Identifier Type: -
Identifier Source: org_study_id