MelanomaEPITHEMNCT04576429
Immune Profiles Evolution Under Immunotherapy for Melanoma
A study testing venous puncture and tumoral biopsy in people with Melanoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort A) or in metastatic setting(cohort B); and to study the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- venous puncture and tumoral biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2021to Jan 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 aged ≥ 18 years;
- Totally resected stage III or IV melanoma totally resected, treated with a immune therapy (pembrolizumab or nivolumab ou other immune checkpoint inhibitors) as adjuvant treatment;
- Unresectable stage IIIC/D or IV metastatic melanoma, treated with immune therapy (pembrolizumab or nivolumab or immune checkpoint inhibitors) which should be associated by a radiotherapy ;
- Patient has been informed about the study and signed the consent;
- Affiliated to the French social security scheme.
Who cannot join
- Pregnant or breastfeeding woman;
- Patient refusal;
- Patient receiving a immunosuppressor;
- Undergo a general corticotherapy of > 10 mg/kg/day since more than 7 days;
- Patient who participate to another blind interventional study receiving blinded treatment;
- Patient without any social protection by organization.
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
Dermato-oncology department, Ambroise Paré hospital, APHP
Boulogne-Billancourt, 92100
About this study
Official title: Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma
The primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort A) or in metastatic setting(cohort B); and to study the association of these immune profiles with relapse- or progression-free survival.
Read the detailed description
This study will analyse the association of biomarkers with relapse- or progression-free survival of stage III or IV melanoma patients, divided in 3 sub-cohorts:
- Patients treated in the adjuvant setting (cohort A): new user of immune checkpoint blockers.
- Patients treated in the metastatic setting (cohort B): - B1: new users of immune checkpoint blockers; - B2: prevalent users of immune checkpoint blockers treated with complementary radiotherapy.
For patients of cohort A and B1, immune profiles characteristics will be evaluated before initiation of treatment (=baseline), and at each radiological evaluation of the tumour response, up to maximum 12 months as duration.
The maximal duration of treatment will be 12 months for patients treated in the adjuvant setting. For metastatic patients, the duration of treatment will be decided by physician according to different factors (responses, progression, toxicities, ...).
For patients in cohort B2, the characteristics of the immune profiles will be evaluated before radiotherapy initiation,, within 6 weeks after the end of radiotherapy, then at the 2 following radiological evaluations of the tumour response
- Conditions
- Melanoma
- Being tested
- venous puncture, tumoral biopsy
- Keywords
- melanoma, immunotherapy, immune profiles
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous punctureProcedure or surgery
Venous punctures will be performed:
for patients of cohort A and B1:
- before the first immune checkpoint inhibitors monoclonal antibodies infusion (baseline);
- between week 6 and week 8 (before the immune checkpoint inhibitors monoclonal antibodies infusion);
- each 3 months up to 12 months. for patients of cohort B2:
- before the radiotherapy;
- within the 6 weeks after the end of radiotherapy;
- at the 2 following evaluations (every 3 months).
tumoral biopsyProcedure or surgery
Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Procedure: venous puncture; Procedure: tumoral biopsy |
| comparator group | Active comparator | Not described Receives: Procedure: venous puncture; Procedure: tumoral biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of relapse/progression-free survival
Will be noted: all progression and event of death. Survival rate will be calculated between the event's day and the beginning of anticancer treatment.
Measured: at 5 years
Secondary outcomes (1)
immunity profiles
ELISA Multiplex method will be used to analyse inflammatory human cytokines in plasma. This method will performe an assay 45-plex fixed panel :
Analytes Included in the Assay
- CCL2/JE/MCP-1
- CCL3/MIP-1 alpha
- CCL4/MIP-1 beta
- CCL5/RANTES
- CCL11/Eotaxin
- CCL19/MIP-3 beta
- CCL20/MIP-3 alpha
- CD40 Ligand/TNFSF5
- CX3CL1/Fractalkine
- CXCL1/GRO alpha/KC/CINC-1
- CXCL2/GRO beta/MIP-2/CINC-3
- CXCL10/IP-10/CRG-2
- EGF
- FGF basic/FGF2/bFGF
- Flt-3 Ligand/FLT3L
- G-CSF
- GM-CSF
- Granzyme B
- IFN-alpha 2/IFNA2
- IFN-beta
- IFN-gamma
- IL-1 alpha/IL-1F1
- IL-1 beta/IL-1F2
- IL-1ra/IL-1F3
- IL-2
- IL-3
- IL-4
- IL-5
- IL-6
- IL-7
- IL-8/CXCL8
- IL-10
- IL-12 p70
- IL-13
- IL-15
- IL-17/IL-17A
- IL-17E/IL-25
- IL-33
- PD-L1/B7-H1
- PDGF-AA
- PDGF-AB/BB
- TGF-alpha
- TNF-alpha
- TRAIL/TNFSF10
- VEGF
Measured: quarterly up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start27 Jan 2021
- Primary completionJan 2031 (estimated)
- Study completionJan 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 Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa FUNCK-BRENTANO, MD, Principal investigator, Dermato-oncology department, Ambroise Paré hospital, APHPJean-François EMILE, MD, PhD, Study director, Pathology department, Ambroise Paré hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576429
- Sponsor's protocol ID
- APHP200947
- Other IDs
- 2019-A02695-52
- Acronym
- EPITHEM
- Status last verified
- Mar 2025
- First submitted
- 14 Sep 2020
- Last updated
- 6 Apr 2025
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma
- ClinicalTrials.gov ID
- NCT04576429
- Acronym / sponsor ID
- EPITHEM / APHP200947
- Conditions
- Melanoma
- Keywords
- melanoma, immunotherapy, immune profiles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 6 Oct 2020 (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.
The primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort A) or in metastatic setting(cohort B); and to study the association of these immune profiles with relapse- or progression-free survival.
Detailed description
This study will analyse the association of biomarkers with relapse- or progression-free survival of stage III or IV melanoma patients, divided in 3 sub-cohorts:
- Patients treated in the adjuvant setting (cohort A): new user of immune checkpoint blockers.
- Patients treated in the metastatic setting (cohort B): - B1: new users of immune checkpoint blockers; - B2: prevalent users of immune checkpoint blockers treated with complementary radiotherapy.
For patients of cohort A and B1, immune profiles characteristics will be evaluated before initiation of treatment (=baseline), and at each radiological evaluation of the tumour response, up to maximum 12 months as duration.
The maximal duration of treatment will be 12 months for patients treated in the adjuvant setting. For metastatic patients, the duration of treatment will be decided by physician according to different factors (responses, progression, toxicities, ...).
For patients in cohort B2, the characteristics of the immune profiles will be evaluated before radiotherapy initiation,, within 6 weeks after the end of radiotherapy, then at the 2 following radiological evaluations of the tumour response
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: venous puncture, Procedure: tumoral biopsy |
| comparator group | Active comparator | Procedure: venous puncture, Procedure: tumoral biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged ≥ 18 years;
- Totally resected stage III or IV melanoma totally resected, treated with a immune therapy (pembrolizumab or nivolumab ou other immune checkpoint inhibitors) as adjuvant treatment;
- Unresectable stage IIIC/D or IV metastatic melanoma, treated with immune therapy (pembrolizumab or nivolumab or immune checkpoint inhibitors) which should be associated by a radiotherapy ;
- Patient has been informed about the study and signed the consent;
- Affiliated to the French social security scheme.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding woman;
- Patient refusal;
- Patient receiving a immunosuppressor;
- Undergo a general corticotherapy of > 10 mg/kg/day since more than 7 days;
- Patient who participate to another blind interventional study receiving blinded treatment;
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 |
|---|---|---|
| venous punctureVenous punctures will be performed: for patients of cohort A and B1: * before the first immune checkpoint inhibitors monoclonal antibodies infusion (baseline); * between week 6 and week 8 (before the immune checkpoint inhibitors monoclonal antibodies infusion); * each 3 months up to 12 months. for patients of cohort B2: * before the radiotherapy; * within the 6 weeks after the end of radiotherapy; * at the 2 following evaluations (every 3 months). | Procedure or surgery | comparator group, experimental group |
| tumoral biopsyCutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care. | Procedure or surgery | comparator group, experimental group |
Primary outcome
Rate of relapse/progression-free survival
Time frame: at 5 years
Will be noted: all progression and event of death. Survival rate will be calculated between the event's day and the beginning of anticancer treatment.
1 secondary outcome
immunity profiles
Time frame: quarterly up to 12 months
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 6 Apr 2025.
- 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.
Elisa FUNCK-BRENTANO, MD principal investigator
Dermato-oncology department, Ambroise Paré hospital, APHP
Jean-François EMILE, MD, PhD study director
Pathology department, Ambroise Paré hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing venous puncture and tumoral biopsy in people with Melanoma, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 6 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 6 Apr 2025. 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 Elisa FUNCK-BRENTANO, MD (+33 (0)1 71 16 77 21, elisa.funck-brentano@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of relapse/progression-free survival (time frame: at 5 years). 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 6 Apr 2025.