Actively Recruiting
Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors
Led by Centre Hospitalier Universitaire de Nice · Updated on 2024-06-04
60
Participants Needed
3
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Person of major age
- Confirmed advanced melanoma
- Disease measurable by RECIST 1.1 criteria
- First line treatment for melanoma
You will not qualify if you...
- Ocular and mucosal melanoma
- Previous treatment with checkpoint inhibitors
- Active brain metastasis
- Use of concomitant immunosuppressive treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-maritimes, France, 06200
Actively Recruiting
2
CHU de Montpellier
Montpellier, Occitanie, France, 34285
Actively Recruiting
3
CHRU de Lille
Lille, France, 59000
Not Yet Recruiting
Research Team
M
Montaudie Henri, PhD
CONTACT
P
Pradelli Emmanuelle
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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