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NCT Number: NCT05029791

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de dermatologie (Bâtiment 1A)

Lyon, 69495, France

Location status: Recruiting

Location contact

Marie Perier-Muzet

SUB_INVESTIGATOR

Myrtille Le Bouar, Msc

CONTACT

[email protected]

04 78 86 15 96 ext. +33

Nicolas Poulalhon

SUB_INVESTIGATOR

Sarah Milley, MD

SUB_INVESTIGATOR

Stéphane Dalle, Pr

CONTACT

[email protected]

04.78.86.16.79 ext. +33

Sébastien Debarbieux

SUB_INVESTIGATOR

Thomas Luc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumor biopsy

Other

2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1)

blood sample

Other

1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1)

Primary outcomes

  1. CD8+ T cells

    Time frame: Month 1 before chemotherapy

    Dosage of CD8+ T cells

  2. CD8+ T cells

    Time frame: Month 1 after chemotherapy

    Dosage of CD8+ T cells

  3. expression of ZEB1 protein

    Time frame: Month 1 before chemotherapy

    Dosage of ZEB 1 protein

  4. expression of ZEB1 protein

    Time frame: Month 1 after chemotherapy

    Dosage of ZEB 1 protein

Secondary outcomes

  1. Clinical response

    Time frame: Week 13

    Partial or complete response as assessed by the clinician

  2. Progression free survival

    Time frame: Week 13

    Time between the date of treatment initiation and the date of first progression

  3. Progression free survival

    Time frame: Every year until 5 years

    Time between the date of treatment initiation and the date of first progression

  4. overall survival

    Time frame: Week 13

    Time between the date of treatment initiation and the patient death

  5. overall survival

    Time frame: Every year until 5 years

    Time between the date of treatment initiation and the patient death

Study contacts

Contact information is provided by the study sponsor or research team.

Myrtille Le Bouar, MSc

CONTACT

[email protected]

04 78 86 15 96 ext. +33

Stéphane Dalle, Pr

CONTACT

[email protected]

04 78 86 16 79 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: COLEMAN

Important dates

Study start
2022
Primary completion
2031
Study completion
2031
First posted
Sep 1, 2021
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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