Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors

Last updated: June 3, 2024
Sponsor: Centre Hospitalier Universitaire de Nice
Overall Status: Active - Recruiting

Phase

N/A

Condition

Melanoma

Treatment

Evaluation of cytokine production

Clinical Study ID

NCT05649683
22-PP-14
  • Ages > 18
  • All Genders

Study Summary

Checkpoint inhibitor such as anti-CTLA-4 and anti-PD-1 are known to block inhibitory signals and increase the immune antimutoral response. Nivolumab and Ipilimumab association is considered as a more efficient immunotherapy to treat advanced melanoma. This combined immunotherapy is also responsible of severe immunes toxicyties. Identification of predictives biomarqueurs remains a challenge to predict the balance between tolerability and efficency. Previous data showed that advanced melanoma patient had lower level of Th1 cytokines that predict a less efficient immune system than healthy donors. The second point was that high level of Th1 and Th17 cytokines were correlate to a better tumor response. The last point was that patients with severe immune toxicity showed an increase of IL-6 and IL17a production. The investigators would like to identify the predictive values of Th1, Th2 and Th17 at the begining and during the combined immunotherapy and correlate these cytokines levels secretions to a potential efficient tumor response or to the emergence of induced immunes toxicities. This study is an original approach using functionnal test to predict the balance between efficienty and tolerability.

Eligibility Criteria

Inclusion

Inclusion

  • persone of major age,

  • advanced melanoma confirmed,

  • RECIST 1.1 disease,

  • first line treatment

Exclusion

Exclusion Criteria:

  • occular and mucosal melanoma,

  • previous checkpoint inhibitor treatment,

  • active brain metastasis,

  • concomitant immunosuppressive treatment

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Evaluation of cytokine production
Phase:
Study Start date:
January 31, 2023
Estimated Completion Date:
June 01, 2027

Connect with a study center

  • CHU de Nice - Hôpital de l'Archet

    Nice, Alpes-maritimes 06200
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier, Occitanie 34285
    France

    Active - Recruiting

  • CHRU de Lille

    Lille, 59000
    France

    Site Not Available

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