MelanomaCOLEMANNCT05029791
Variations of Immune Infiltrate and Cell Plasticity Markers in Treated Metastatic Melanoma Patients
A study testing Tumor biopsy and Blood sample in people with Melanoma, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Tumor biopsy and Blood sample
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2022to 18 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de dermatologie (Bâtiment 1A)
Lyon, 69495
Stéphane Dalle, Pr, 04.78.86.16.79 ext. +33, stephane.dalle@chu-lyon.fr
Myrtille Le Bouar, Msc, 04 78 86 15 96 ext. +33, myrtille.le-bouar@chu-lyon.fr
About this study
Official title: Study of Variations of Immune Infiltrate and Cell Plasticity Markers in Patients With Metastatic Melanoma Under Treatment
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.
- Conditions
- Melanoma
- Being tested
- Tumor biopsy, Blood sample
- Keywords
- Melanoma, Immune Infiltrate, Cell plasticity markers
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor biopsyOther
2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1)
Blood sampleOther
1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1)
| Study group | Role | What they receive |
|---|---|---|
| Metastatic melanoma | Other | Patients with stage III or IV melanoma eligible for an immunotherapy or targeted therapy Receives: Other: Tumor biopsy; Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD8+ T cells
Dosage of CD8+ T cells
Measured: Month 1 before chemotherapy
CD8+ T cells
Dosage of CD8+ T cells
Measured: Month 1 after chemotherapy
expression of ZEB1 protein
Dosage of ZEB 1 protein
Measured: Month 1 before chemotherapy
expression of ZEB1 protein
Dosage of ZEB 1 protein
Measured: Month 1 after chemotherapy
Secondary outcomes (5)
Clinical response
Partial or complete response as assessed by the clinician
Measured: Week 13
Progression free survival
Time between the date of treatment initiation and the date of first progression
Measured: Week 13
Progression free survival
Time between the date of treatment initiation and the date of first progression
Measured: Every year until 5 years
overall survival
Time between the date of treatment initiation and the patient death
Measured: Week 13
overall survival
Time between the date of treatment initiation and the patient death
Measured: Every year until 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start18 Aug 2022
- Primary completion18 Nov 2031 (estimated)
- Study completion18 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029791
- Sponsor's protocol ID
- 69HCL21_0906
- Acronym
- COLEMAN
- Status last verified
- Dec 2023
- First submitted
- 23 Aug 2021
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Variations of Immune Infiltrate and Cell Plasticity Markers in Patients With Metastatic Melanoma Under Treatment
- ClinicalTrials.gov ID
- NCT05029791
- Acronym / sponsor ID
- COLEMAN / 69HCL21_0906
- Conditions
- Melanoma
- Keywords
- Melanoma, Immune Infiltrate, Cell plasticity markers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 18 Nov 2031 (estimated)
- Study completion
- 18 Nov 2031 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic melanoma | Other | Other: Tumor biopsy, Other: Blood samplePatients with stage III or IV melanoma eligible for an immunotherapy or targeted therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor biopsy2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1) | Other | Metastatic melanoma |
| Blood sample1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1) | Other | Metastatic melanoma |
Primary outcome
CD8+ T cells
Time frame: Month 1 before chemotherapy
Dosage of CD8+ T cells
CD8+ T cells
Time frame: Month 1 after chemotherapy
Dosage of CD8+ T cells
expression of ZEB1 protein
Time frame: Month 1 before chemotherapy
Dosage of ZEB 1 protein
expression of ZEB1 protein
Time frame: Month 1 after chemotherapy
Dosage of ZEB 1 protein
5 secondary outcomes
Clinical response
Time frame: Week 13
Progression free survival
Time frame: Week 13
Progression free survival
Time frame: Every year until 5 years
overall survival
Time frame: Week 13
overall survival
Time frame: Every year until 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor biopsy and Blood sample in people with Melanoma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Dalle, Pr (04 78 86 16 79 ext. +33, Florence.guillemaud@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD8+ T cells (time frame: Month 1 before chemotherapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.