RecruitingNot ApplicableNCT05649683

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

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


Sponsor

Centre Hospitalier Universitaire de Nice

Enrollment

60 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new blood test in patients with advanced melanoma to predict whether immunotherapy (checkpoint inhibitors) will work for them before starting treatment. This could help doctors choose the right therapy sooner. **You may be eligible if...** - You are 18 or older with confirmed advanced (metastatic) melanoma - You are about to start first-line immunotherapy treatment - Your cancer is measurable on scans **You may NOT be eligible if...** - You have ocular (eye) or mucosal melanoma - You have already received immunotherapy - You have active brain metastases - You are on immunosuppressive medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(3)

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-maritimes, France

CHU de Montpellier

Montpellier, Occitanie, France

CHRU de Lille

Lille, France

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NCT05649683


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