Melanoma
Conditions
Keywords
Melanoma, Immune Infiltrate, Cell plasticity markers
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.
Interventions
OTHERTumor biopsy
2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1)
OTHERBlood sample
1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1)
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CD8+ T cells | Month 1 before chemotherapy | Dosage of CD8+ T cells |
| expression of ZEB1 protein | Month 1 before chemotherapy | Dosage of ZEB 1 protein |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | Week 13 | Partial or complete response as assessed by the clinician |
| Progression free survival | Week 13 | Time between the date of treatment initiation and the date of first progression |
| overall survival | Week 13 | Time between the date of treatment initiation and the patient death |
Countries
France
Contacts
Primary ContactStéphane Dalle, Pr
Backup ContactMyrtille Le Bouar, MSc
Outcome results
None listed