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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

persone of major age,

advanced melanoma confirmed,

RECIST 1.1 disease,

first line treatment

Disqualifiers

occular and mucosal melanoma,

previous checkpoint inhibitor treatment,

active brain metastasis,

concomitant immunosuppressive treatment

Trial design

Design model

Single group

Treatments tested in this trial

  • Evaluation of cytokine production

    Biological/Vaccine

    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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Analysis of blood cytokineOther 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the RECIST 1.1 tumoral response

Analysis of blood cytokine secretion upon non specific in vitro stimulation RECIST 1.1 tumor response

Time frame
Change from Baseline tumoral response at week 6 and at week 11

Secondary outcomes

1

Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the progression free

Analysis of blood cytokine secretion upon non specific in vitro stimulation disease progression

Time frame
Change from Baseline disease progression at week 6 and at week 11
2

Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to severe immunological toxicity occurrence

Analysis of blood cytokine secretion upon non specific in vitro stimulation severe immunological toxicity occurrence

Time frame
Change from Baseline immunological toxicity occurrence at week 6 and at week 11

Other outcomes

Sponsors and contacts

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