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NCT Number: NCT04576429

Immune Profiles Evolution Under 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermato-oncology department, Ambroise Paré hospital, APHP

Boulogne-Billancourt, 92100, France

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

venous puncture

Procedure

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 biopsy

Procedure

Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care.

Primary outcomes

  1. 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.

Secondary outcomes

  1. immunity profiles

    Time frame: quarterly up to 12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa FUNCK-BRENTANO, MD

CONTACT

[email protected]

+33 (0)1 71 16 77 21

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma

Acronym: EPITHEM

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Oct 6, 2020
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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