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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma
• Intervention / Treatment: Other: Tumor biopsy; Other: Blood sample

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphane Dalle, Pr; Phone Number: +33 04 78 86 16 79; Email: Florence.guillemaud@chu-lyon.fr
• Study Contact Backup: Name: Myrtille Le Bouar, Msc; Phone Number: +33 04 78 86 15 96; Email: myrtille.le-bouar@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69495
    • Recruiting
    • Service de dermatologie (Bâtiment 1A)
    • Contact: Myrtille Le Bouar, Msc; Phone Number: +33 04 78 86 15 96; Email: myrtille.le-bouar@chu-lyon.fr
    • Contact: Stéphane Dalle, Pr; Phone Number: +33 04.78.86.16.79; Email: stephane.dalle@chu-lyon.fr
    • Sub-Investigator: Sarah Milley, MD
    • Sub-Investigator: Nicolas Poulalhon
    • Sub-Investigator: Marie Perier-Muzet
    • Sub-Investigator: Sébastien Debarbieux
    • Sub-Investigator: Thomas Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Estimated): November 18, 2031
• Study Completion (Estimated): November 18, 2031

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Melanoma; Immune Infiltrate; Cell plasticity markers
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 69HCL21_0906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No