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

NCT04253080 | Unknown

• 2 other identifiers: APHP1902432019-A01985-52
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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). 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)).

Conditions

Cutaneous Melanoma

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)

Outcome Measures

Primary Outcomes (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

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

Study Arms (3)

patients with primary thin melanoma < or = 1mm

NO INTERVENTION

patients with primary thin melanoma (Breslow thickness less than or equal 1 mm)

patients with primary thick melanoma > or = 3 mm

NO INTERVENTION

patients with primary thick melanoma (Breslow greater than or equal 3 mm)

patient with melanoma who received treatment

OTHER

patient with melanoma (stages III or IV inoperable) and who received first line treatment with immunotherapy and / or targeted therapies

Biological: Blood sample; Biological: Cutaneous melanoma biopsy

Interventions

Blood sample BIOLOGICAL

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

patient with melanoma who received treatment

Cutaneous melanoma biopsy BIOLOGICAL

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

patient with melanoma who received treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Association Robert Debré (ARD): collaborator
• Société de Dermatologie Française: collaborator
• Institut Cochin: collaborator

Study Sites (1)

Dermatology department

Paris, Île-de-France Region, 75014, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 30048651 BACKGROUND

• 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.

  PMID: 28405502 BACKGROUND

MeSH Terms

Conditions

Melanoma; Diabetes Mellitus, Insulin-Dependent, 12

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Armelle Blondel, MD, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nora Kramkimel, MD, PhD

CONTACT

+33 1 58 41 19 80; nora.kramkimel@aphp.fr

Christelle Auger

CONTACT

+33 1 58 41 11 86; christelle.auger@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: April 12, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)