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

Not Applicable

Recruiting

• Conditions: Melanoma
• Interventions: Other: Tumor biopsy; Other: Blood sample

• Registration Number: NCT05029791
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-01
• Study Start: 2022-08-18
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-15
• Primary Completion: 2031-11-18
• Study Completion: 2031-11-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metastatic melanoma	Tumor biopsy	Patients with stage III or IV melanoma eligible for an immunotherapy or targeted therapy
Metastatic melanoma	Blood sample	Patients with stage III or IV melanoma eligible for an immunotherapy or targeted therapy

Primary Outcome Measures

Name	Time	Method
expression of ZEB1 protein	Month 1 after chemotherapy	Dosage of ZEB 1 protein
CD8+ T cells	Month 1 after chemotherapy	Dosage of CD8+ T cells

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service de dermatologie (Bâtiment 1A); 🇫🇷 Lyon, France