Melanoma (Skin)
Conditions
Brief 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.
Interventions
BIOLOGICALEvaluation of cytokine production
The patient will have samples at initiation of treatment (J0), after treatments 1 and 2 (S6), after the first radiological assessment at S11 and/or the progression of the disease and/or occurrence of a grade 3-4 adverse event
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the RECIST 1.1 tumoral response | Change from Baseline tumoral response at week 6 and at week 11 | Analysis of blood cytokine secretion upon non specific in vitro stimulation RECIST 1.1 tumor response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the progression free | Change from Baseline disease progression at week 6 and at week 11 | Analysis of blood cytokine secretion upon non specific in vitro stimulation disease progression |
| Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to severe immunological toxicity occurrence | Change from Baseline immunological toxicity occurrence at week 6 and at week 11 | Analysis of blood cytokine secretion upon non specific in vitro stimulation severe immunological toxicity occurrence |
Countries
France
Contacts
Primary ContactMontaudie Henri, PhD
Backup ContactPradelli Emmanuelle
Outcome results
None listed