Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Evaluation of cytokine production.
- Who it may be relevant to
- Registry conditions: Melanoma (Skin). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors - Melanoma Quantiferon
Overview
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
- Biological Evaluation 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
Primary outcome measures
- Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the RECIST 1.1 tumoral response [Time frame: Change from Baseline tumoral response at week 6 and at week 11]
Secondary outcome measures (2)
- Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the progression free [Time frame: Change from Baseline disease progression at week 6 and at week 11]
- Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to severe immunological toxicity occurrence [Time frame: Change from Baseline immunological toxicity occurrence at week 6 and at week 11]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 3 centers
- CHU de Nice - Hôpital de l'Archet — Nice
- CHU de Montpellier — Montpellier
- CHRU de Lille — Lille
Identifiers
NCT: NCT05649683 · 22-PP-14