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

Primary Purpose

Melanoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tumor biopsy
Blood sample
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Melanoma focused on measuring Melanoma, Immune Infiltrate, Cell plasticity markers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de dermatologie (Bâtiment 1A)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Metastatic melanoma

Arm Description

Patients with stage III or IV melanoma eligible for an immunotherapy or targeted therapy

Outcomes

Primary Outcome Measures

CD8+ T cells
Dosage of CD8+ T cells
CD8+ T cells
Dosage of CD8+ T cells
expression of ZEB1 protein
Dosage of ZEB 1 protein
expression of ZEB1 protein
Dosage of ZEB 1 protein

Secondary Outcome Measures

Clinical response
Partial or complete response as assessed by the clinician
Progression free survival
Time between the date of treatment initiation and the date of first progression
Progression free survival
Time between the date of treatment initiation and the date of first progression
overall survival
Time between the date of treatment initiation and the patient death
overall survival
Time between the date of treatment initiation and the patient death

Full Information

First Posted
August 23, 2021
Last Updated
August 30, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05029791
Brief Title
Variations of Immune Infiltrate and Cell Plasticity Markers in Treated Metastatic Melanoma Patients
Acronym
COLEMAN
Official Title
Study of Variations of Immune Infiltrate and Cell Plasticity Markers in Patients With Metastatic Melanoma Under Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2030 (Anticipated)
Study Completion Date
December 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Immune Infiltrate, Cell plasticity markers

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metastatic melanoma
Arm Type
Other
Arm Description
Patients with stage III or IV melanoma eligible for an immunotherapy or targeted therapy
Intervention Type
Other
Intervention Name(s)
Tumor biopsy
Intervention Description
2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1)
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1)
Primary Outcome Measure Information:
Title
CD8+ T cells
Description
Dosage of CD8+ T cells
Time Frame
Month 1 before chemotherapy
Title
CD8+ T cells
Description
Dosage of CD8+ T cells
Time Frame
Month 1 after chemotherapy
Title
expression of ZEB1 protein
Description
Dosage of ZEB 1 protein
Time Frame
Month 1 before chemotherapy
Title
expression of ZEB1 protein
Description
Dosage of ZEB 1 protein
Time Frame
Month 1 after chemotherapy
Secondary Outcome Measure Information:
Title
Clinical response
Description
Partial or complete response as assessed by the clinician
Time Frame
Week 13
Title
Progression free survival
Description
Time between the date of treatment initiation and the date of first progression
Time Frame
Week 13
Title
Progression free survival
Description
Time between the date of treatment initiation and the date of first progression
Time Frame
Every year until 5 years
Title
overall survival
Description
Time between the date of treatment initiation and the patient death
Time Frame
Week 13
Title
overall survival
Description
Time between the date of treatment initiation and the patient death
Time Frame
Every year until 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane Dalle, Pr
Phone
04 78 86 16 79
Ext
+33
Email
Florence.guillemaud@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Myrtille Le Bouar, MSc
Phone
04 78 86 15 96
Ext
+33
Email
myrtille.le-bouar@chu-lyon.fr
Facility Information:
Facility Name
Service de dermatologie (Bâtiment 1A)
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Dalle, Pr
Phone
04.78.86.16.79
Ext
+33
Email
stephane.dalle@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Myrtille Le Bouar, Msc
Phone
04 78 86 15 96
Ext
+33
Email
myrtille.le-bouar@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Sarah Milley, MD
First Name & Middle Initial & Last Name & Degree
Nicolas Poulalhon
First Name & Middle Initial & Last Name & Degree
Marie Perier-Muzet
First Name & Middle Initial & Last Name & Degree
Sébastien Debarbieux
First Name & Middle Initial & Last Name & Degree
Thomas Luc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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