NCT05649683 Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors
| NCT ID | NCT05649683 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Melanoma (Skin) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-31 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-01-31 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Montaudie Henri, PhD
PRINCIPAL INVESTIGATOR
CHU de Nice, Service de Dermatologie
Frequently Asked Questions
Who can join the NCT05649683 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma (Skin). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05649683 currently recruiting?
Yes, NCT05649683 is actively recruiting participants. Contact the research team at montaudie.h@chu-nice.fr for enrollment information.
Where is the NCT05649683 trial being conducted?
This trial is being conducted at Nice, France, Montpellier, France, Lille, France.
Who is sponsoring the NCT05649683 clinical trial?
NCT05649683 is sponsored by Centre Hospitalier Universitaire de Nice. The principal investigator is Montaudie Henri, PhD at CHU de Nice, Service de Dermatologie. The trial plans to enroll 60 participants.
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