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Cutaneous MelanomaENZYMELANCT04253080

Expression of IL4 Induced Gene 1 in Patients With Cutaneous Melanoma: Value in Prognosis and/or in Predictive Response to Immune Checkpoint Inhibitors

A study testing Blood sample and Cutaneous melanoma biopsy in people with Cutaneous Melanoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To characterize and quantify immune cells expressing the Interleukine 4 induced gene 1 (IL4I1) immunosuppressive enzyme in the blood and in tissue of melanoma patients (primary tumor, sentinel lymph nodes and cutaneous metastases). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cutaneous Melanoma
What is being tested?
Blood sample and Cutaneous melanoma biopsy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
1 siteFrance
Study dates
12 Apr 2022to 4 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

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

  • group 1: patients with primary thin melanoma (Breslow thickness less than or equal to1 mm) monitored for 10 years, having relapsed or not within 10 years after the diagnosis.
  • patients with no other concomitant cancers requiring systemic treatment at the time of diagnosis of primary melanoma
  • patient or patient's family (in case of death) informed of the objectives and modalities of the study and not opposed to participation in the study
  • patient or patient's family (in case of death) not opposed to the use of part of the skin sample previously taken for the present research
  • group 2: patients with primary thick melanoma (Breslow greater than or equal to 3 mm) monitored for 5 years, having relapsed or not within 5 years after diagnosis.
  • patient with no other concomitant cancers requiring systemic treatment at the time of diagnosis of primary melanoma
Show all 11Show fewer
  • patient or patient's family (in case of death) informed of the objectives and modalities of the study and not opposed to participation in the study
  • patient or patient's family (in case of death) not opposed to the use of part of the skin sample previously taken for the present research
  • group 3: patient with melanoma (stages III or IV inoperable) and who are treated with immunotherapy and / or biotherapy
  • patient with no other concomitant cancers requiring systemic treatment at the time of diagnosis of primary melanoma and initiation of systemic treatment for melanoma
  • patient informed of the objectives and modalities of the study and having given informed and written consent to participate in the study

Who cannot join

  • groups 1 and 2: patient or family of the patient opposed (e) that part of the primary melanoma taken previously is used in the context of the present project
  • group 3 :
  • refusal of the patient to participate in the study
  • patient unable to understand the study and sign consent
  • patient with a known contraindication to xylocaine
  • patient not affiliated to a social security system (beneficiary or beneficiary's right)
  • adult subject to a legal protection measure

Trial locations and contacts

1 site in 1 country.

France1 site

  • Dermatology department

    Paris, Île-de-France Region, 75014

Other trials in France

About this study

Official title: Impact of the IL4I1 Enzyme Expression in Patients With Cutaneous Melanoma: Prognostic Value and/or Role in Resistance to Current Immunotherapy and Targeted Therapy

To characterize and quantify immune cells expressing the Interleukine 4 induced gene 1 (IL4I1) immunosuppressive enzyme in the blood and in tissue of melanoma patients (primary tumor, sentinel lymph nodes and cutaneous metastases).

Then, to compare the results obtained in different clinical settings:

  • in cases of progression of the disease slower or faster compared to the prognosis established by clinical and pathological data
  • before and after treatments with immunotherapy (anti Programmed Death ligand 1 (anti-PD1) or anti-PD1 and anti Cytotoxic T Lymphocyte associated protein 4 (anti-CTLA-4)) and / or targeted therapies (BRAF inhibitors and /or methyl ethyl ketone (MEK)).
Read the detailed description

The incidence of cutaneous melanoma is increasing, but the current prognostic parameters mainly based on histological data are insufficient to identify patients with high risk of recidive. In addition, current immunotherapies using PD-1 and/or CTLA-4 antibodies have long-lasting tumor control in a substantial fraction of patients but identify new markers of treatment resistance need further investigations. Clinical data highlight enzymes involved in amino acid catabolism as new potential prognostic markers in human melanoma. Among those, the IL4I1 phenylalanine oxidase may be a new relevant marker and may represent an easily targetable molecule for cancer immunotherapy.

The current retrospective study is designed to evaluate whether a high proportion of IL4I1 positive cells within the primary tumor and/or sentinel lymph nodes allows to predict the risk of cancer recurrence from the clinical diagnosis. Immunofluorescence and immunohistochemistry will be performed.

The longitudinal study of IL4I1 positive cells in the blood and cutaneous metastasis od patients will start before and after (three months and 1 year (or before in case of treatment resistance) the treatment with targeted therapy and/or immunotherapy as a first line. Treatment will be administered on an outpatient basis. No investigational or commercial cancer directed agents or therapies other than those described below may be administered.

It is designed to evaluate whether patients that resist to treatments exhibit a high proportion of IL4I1 positive cells and how is regulated the enzyme in the course of the treatment.

Being tested
Blood sample, Cutaneous melanoma biopsy
Keywords
cutaneous melanoma, marker for prognosis and response to targeted treatment and/or immune checkpoint inhibitor, Programmed Death ligand 1 (PD1), Cytotoxic T Lymphocyte Associated 4 (CTLA-A4)
Medical subject headings
Melanoma, Diabetes Mellitus, Insulin-Dependent, 12

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleBiological

    Blood sample before treatment, 3 months after treatment and after 1 year or relapse or resumption of disease progression.

  • Cutaneous melanoma biopsyBiological

    Cutaneous melanoma biopsy before treatment, 3 months after treatment and relapse or resumption of disease progression.

Study groups in NCT04253080
Study groupRoleWhat they receive
patients with primary thin melanoma < or = 1mmNo interventionpatients with primary thin melanoma (Breslow thickness less than or equal 1 mm)
patients with primary thick melanoma > or = 3 mmNo interventionpatients with primary thick melanoma (Breslow greater than or equal 3 mm)
patient with melanoma who received treatmentOtherpatient with melanoma (stages III or IV inoperable) and who received first line treatment with immunotherapy and / or targeted therapies
Receives: Biological: Blood sample; Biological: Cutaneous melanoma biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Role of IL4I1+ cells in prognosis and in response to treatments (targeted and/or antiPD1/CTLA4 based therapies) in cutaneous melanoma

    Detection of IL4I1+ cells in tissue and/or blood

    Measured: 12 months or between 6 and 12 months (if disease progression)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start12 Apr 2022
  3. Primary completion4 Nov 2024
  4. Study completion4 Nov 2024

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04253080
Sponsor's protocol ID
APHP190243
Other IDs
2019-A01985-52
Acronym
ENZYMELA
Status last verified
May 2026
First submitted
31 Jan 2020
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The clinical data at the diagnosis and the relapse/no relapse information have to be shared from the groups 1 and 2. The clinical response to treatments will be shared.

Publications

  • Ramspott JP, Bekkat F, Bod L, Favier M, Terris B, Salomon A, Djerroudi L, Zaenker KS, Richard Y, Molinier-Frenkel V, Castellano F, Avril MF, Prevost-Blondel A. Emerging Role of IL-4-Induced Gene 1 as a Prognostic Biomarker Affecting the Local T-Cell Response in Human Cutaneous Melanoma. J Invest Dermatol. 2018 Dec;138(12):2625-2634. doi: 10.1016/j.jid.2018.06.178. Epub 2018 Jul 23.

    PubMed 30048651

  • Bod L, Lengagne R, Wrobel L, Ramspott JP, Kato M, Avril MF, Castellano F, Molinier-Frenkel V, Prevost-Blondel A. IL4-induced gene 1 promotes tumor growth by shaping the immune microenvironment in melanoma. Oncoimmunology. 2017 Jan 13;6(3):e1278331. doi: 10.1080/2162402X.2016.1278331. eCollection 2017.

    PubMed 28405502

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample and Cutaneous melanoma biopsy in people with Cutaneous 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 11 inclusion and 7 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: finished, as of the sponsor's last update on 20 May 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Role of IL4I1+ cells in prognosis and in response to treatments (targeted and/or antiPD1/CTLA4 based therapies) in cutaneous melanoma (time frame: 12 months or between 6 and 12 months (if disease progression)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04253080, which also lists 2 linked publications.

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 20 May 2026.

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