Variations of Immune Infiltrate and Cell Plasticity Markers in Treated Metastatic Melanoma Patients

Study Overview
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Brief Summary
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COLEMAN is an opened prospective monocentric non-randomized study, initiated by the Hospices Civils de Lyon. Population targeted are patients from 18 years old with stage III or IV metastatic melanoma eligible for a metastatic melanoma treatment administered as part of usual care. 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.

Official Title
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Study of Variations of Immune Infiltrate and Cell Plasticity Markers in Patients With Metastatic Melanoma Under Treatment

Conditions
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Melanoma

Intervention / Treatment
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* Other: Tumor biopsy
* Other: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age ≥ 18 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: Hematologic tumours under treatment 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Metastatic melanoma<br>Patients with stage III or IV melanoma eligible for an immunotherapy or targeted therapy | Other: Tumor biopsy<br>* 2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1)<br>Other: Blood sample<br>* 1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD8+ T cells | Dosage of CD8+ T cells | Month 1 before chemotherapy | 
| CD8+ T cells | Dosage of CD8+ T cells | Month 1 after chemotherapy | 
| expression of ZEB1 protein | Dosage of ZEB 1 protein | Month 1 before chemotherapy | 
| expression of ZEB1 protein | Dosage of ZEB 1 protein | Month 1 after chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Partial or complete response as assessed by the clinician | Week 13 | 
| Progression free survival | Time between the date of treatment initiation and the date of first progression | Week 13 | 
| Progression free survival | Time between the date of treatment initiation and the date of first progression | Every year until 5 years | 
| overall survival | Time between the date of treatment initiation and the patient death | Week 13 | 
| overall survival | Time between the date of treatment initiation and the patient death | Every year until 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Immune Infiltrate, Cell plasticity markers