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

Melanoma Clinical Trial

— COLEMAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029791
• Other study ID #: 69HCL21_0906
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2022
• Est. completion date: November 18, 2031

Study information

• Verified date: December 2023
• Source: Hospices Civils de Lyon
• Contact: Stéphane Dalle, Pr
• Phone: 04 78 86 16 79
• Email: Florence.guillemaud[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 18, 2031
• Est. primary completion date: November 18, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• 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)

Locations

Country	Name	City	State
France	Service de dermatologie (Bâtiment 1A)	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD8+ T cells	Dosage of CD8+ T cells	Month 1 before chemotherapy
Primary	CD8+ T cells	Dosage of CD8+ T cells	Month 1 after chemotherapy
Primary	expression of ZEB1 protein	Dosage of ZEB 1 protein	Month 1 before chemotherapy
Primary	expression of ZEB1 protein	Dosage of ZEB 1 protein	Month 1 after chemotherapy
Secondary	Clinical response	Partial or complete response as assessed by the clinician	Week 13
Secondary	Progression free survival	Time between the date of treatment initiation and the date of first progression	Week 13
Secondary	Progression free survival	Time between the date of treatment initiation and the date of first progression	Every year until 5 years
Secondary	overall survival	Time between the date of treatment initiation and the patient death	Week 13
Secondary	overall survival	Time between the date of treatment initiation and the patient death	Every year until 5 years