NCT05029791

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
67mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Aug 2022Nov 2031

First Submitted

Initial submission to the registry

August 23, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

August 18, 2022

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2031

Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

9.3 years

First QC Date

August 23, 2021

Last Update Submit

December 11, 2023

Conditions

Melanoma

Keywords

MelanomaImmune InfiltrateCell plasticity markers

Outcome Measures

Primary Outcomes (4)

  • CD8+ T cells

    Dosage of CD8+ T cells

    Month 1 before chemotherapy

  • CD8+ T cells

    Dosage of CD8+ T cells

    Month 1 after chemotherapy

  • expression of ZEB1 protein

    Dosage of ZEB 1 protein

    Month 1 before chemotherapy

  • expression of ZEB1 protein

    Dosage of ZEB 1 protein

    Month 1 after chemotherapy

Secondary Outcomes (5)

  • Clinical response

    Week 13

  • Progression free survival

    Week 13

  • Progression free survival

    Every year until 5 years

  • overall survival

    Week 13

  • overall survival

    Every year until 5 years

Study Arms (1)

Metastatic melanoma

OTHER

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

Other: Tumor biopsyOther: Blood sample

Interventions

Tumor biopsyOTHER

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

Metastatic melanoma
Blood sampleOTHER

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

Metastatic melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hematologic tumours under treatment
  • Patients with a documented history of autoimmune pathology
  • Ocular melanoma
  • Persons placed under the safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de dermatologie (Bâtiment 1A)

Lyon, 69495, France

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Stéphane Dalle, Pr

CONTACT

04 78 86 16 79Florence.guillemaud@chu-lyon.fr

Myrtille Le Bouar, MSc

CONTACT

04 78 86 15 96myrtille.le-bouar@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

September 1, 2021

Study Start

August 18, 2022

Primary Completion (Estimated)

November 18, 2031

Study Completion (Estimated)

November 18, 2031

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)