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

Melanoma (Skin) Clinical Trial

— mela-quantif  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649683
• Other study ID #: 22-PP-14
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Montaudie Henri, PhD
• Phone: 33492036083
• Email: montaudie.h[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

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

Locations

Country	Name	City	State
France	CHRU de Lille	Lille
France	CHU de Montpellier	Montpellier	Occitanie
France	CHU de Nice - Hôpital de l'Archet	Nice	Alpes-maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the RECIST 1.1 tumoral response	Analysis of blood cytokine secretion upon non specific in vitro stimulation RECIST 1.1 tumor response	Change from Baseline tumoral response at week 6 and at week 11
Secondary	Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the progression free	Analysis of blood cytokine secretion upon non specific in vitro stimulation disease progression	Change from Baseline disease progression at week 6 and at week 11
Secondary	Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to severe immunological toxicity occurrence	Analysis of blood cytokine secretion upon non specific in vitro stimulation severe immunological toxicity occurrence	Change from Baseline immunological toxicity occurrence at week 6 and at week 11