Clinical trial NCT05649683: Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors
Official title: Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors - Melanoma Quantiferon
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma (Skin)
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the RECIST 1.1 tumoral response
timeFrame: Change from Baseline tumoral response at week 6 and at week 11
Secondary outcomes:
measure: Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the progression free
timeFrame: Change from Baseline disease progression at week 6 and at week 11
measure: Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to severe immunological toxicity occurrence
timeFrame: Change from Baseline immunological toxicity occurrence at week 6 and at week 11
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet
state: Alpes-maritimes
city: Montpellier
country: France
facility: CHU de Montpellier
state: Occitanie
city: Lille
country: France
facility: CHRU de Lille
Study officials:
affiliation: CHU de Nice, Service de Dermatologie
name: Montaudie Henri, PhD
role: PRINCIPAL_INVESTIGATOR
References: