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

About this study

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.

Condition
Melanoma (Skin)
Tested
Evaluation of cytokine production
Sponsor
Centre Hospitalier Universitaire de Nice

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 7

  • Minimum age: 18 years
  • Study condition: Melanoma (Skin)
  • Inclusion
  • persone of major age,
  • advanced melanoma confirmed,
  • RECIST 1.1 disease,
  • first line treatment

Exclusion 4

  • occular and mucosal melanoma,
  • previous checkpoint inhibitor treatment,
  • active brain metastasis,
  • concomitant immunosuppressive treatment

Where

3 sites, 3 recruiting

CHU de Montpellier

Montpellier, Occitanie, France

Recruiting

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-maritimes, France

Recruiting

CHRU de Lille

Lille, France

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.