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

Not Applicable

Recruiting

• Conditions: Melanoma (Skin)

• Registration Number: NCT05649683
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-24
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-14
• Study Start: 2023-01-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2027-02-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

• occular and mucosal melanoma,
• previous checkpoint inhibitor treatment,
• active brain metastasis,
• concomitant immunosuppressive treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the RECIST 1.1 tumoral response	Change from Baseline tumoral response at week 6 and at week 11	Analysis of blood cytokine secretion upon non specific in vitro stimulation RECIST 1.1 tumor response

Secondary Outcome Measures

Name	Time	Method
Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to severe immunological toxicity occurrence	Change from Baseline immunological toxicity occurrence at week 6 and at week 11	Analysis of blood cytokine secretion upon non specific in vitro stimulation severe immunological toxicity occurrence
Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the progression free	Change from Baseline disease progression at week 6 and at week 11	Analysis of blood cytokine secretion upon non specific in vitro stimulation disease progression

Trial Locations

Locations (3)

CHU de Nice - Hôpital de l'Archet; 🇫🇷 Nice, Alpes-maritimes, France

CHU de Montpellier; 🇫🇷 Montpellier, Occitanie, France

CHRU de Lille; 🇫🇷 Lille, France