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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05029791
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hospices Civils de Lyon
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma

Arms & Interventions

Arms

Other: Metastatic melanoma

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

Interventions

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Service de dermatologie (Bâtiment 1A), Lyon, France

Status

Recruiting

Address

Service de dermatologie (Bâtiment 1A)

Lyon, , 69495

Site Contact

Stéphane Dalle, Pr

stephane.dalle@chu-lyon.fr

04.78.86.16.79 #+33

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