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Clinical Trials in France / NCT05029791
Recruiting Not applicable

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

NCT05029791 · tracked via the Priya Life Science France tracker
Sponsor
Hospices Civils de Lyon
Phase
Not applicable
Started
2022-08-18
Last updated
2023-12-15

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

Tumor biopsyBlood sample

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)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • CD8+ T cells — Month 1 before chemotherapy
    Dosage of CD8+ T cells
  • CD8+ T cells — Month 1 after chemotherapy
    Dosage of CD8+ T cells
  • expression of ZEB1 protein — Month 1 before chemotherapy
    Dosage of ZEB 1 protein
  • expression of ZEB1 protein — Month 1 after chemotherapy
    Dosage of ZEB 1 protein

Trial sites (1)

FacilityCityRegionStatus
Service de dermatologie (Bâtiment 1A) Lyon France Recruiting

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Other trials for the same condition

A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma Active, not recruiting
A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients Active, not recruiting
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051) Recruiting
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. Recruiting
A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05029791 on ClinicalTrials.gov ↗ ← All trials in France