Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors (mela-quantif)
Melanoma (Skin)
About this trial
This is an interventional other trial for Melanoma (Skin)
Eligibility Criteria
Inclusion persone of major age, advanced melanoma confirmed, RECIST 1.1 disease, first line treatment Exclusion Criteria: occular and mucosal melanoma, previous checkpoint inhibitor treatment, active brain metastasis, concomitant immunosuppressive treatment
Sites / Locations
- CHU de Nice - Hôpital de l'ArchetRecruiting
- CHU de MontpellierRecruiting
- CHRU de Lille
Arms of the Study
Arm 1
Other
Analysis of blood cytokine
Patients will receive anti-PD1 therapy (Nivolumab/Nivo) with anti-CTLA4 therapy (Ipilimumab/Ipi) as part of routine care, as per the MA scheme followed in case of efficacy and good tolerance of Nivolumab maintenance treatment alone. The functional test for cytokines (1ml total blood on lihtium heparinate) will be performed at the initiation of ICI (J0), at week 6 (S6, after the 2nd cure), at week 11 (S11= 1st radiological evaluation, after the 4 cures of Nivo+Ipi), and, if applicable, the progression of the disease and/or the occurrence of an ESi grade 3-4. Stimulated lymphocytes from non-therapy responders will be tested in vitro by various immunomodulatory drugs. During each sampling we will also collect 5 ml of serum on dry tube for serological constitution, 3ml on EDTA tube for performing an immunophenotyping (T, B, NK) and 3ml on EDTA tube for freezing total PBMC and setting up a biobank.