mela-quantif: Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05649683
• Collaborator: (none)
• Enrollment: 60
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 53.6
• Patients Per Site: 20
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Biological: Evaluation of cytokine production	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors - Melanoma Quantiferon
• Anticipated Study Start Date: Dec 12, 2022
• Anticipated Primary Completion Date: Feb 1, 2027
• Anticipated Study Completion Date: Jun 1, 2027

Arms and Interventions

Arm

Intervention/Treatment

Other: Analysis of blood cytokine Patients will receive anti-PD1 therapy (Nivolumab/Nivo) with anti-CTLA4 therapy (Ipilimumab/Ipi) as part of routine care, as per the MA scheme followed in case of efficacy and good tolerance of Nivolumab maintenance treatment alone. The functional test for cytokines (1ml total blood on lihtium heparinate) will be performed at the initiation of ICI (J0), at week 6 (S6, after the 2nd cure), at week 11 (S11= 1st radiological evaluation, after the 4 cures of Nivo+Ipi), and, if applicable, the progression of the disease and/or the occurrence of an ESi grade 3-4. Stimulated lymphocytes from non-therapy responders will be tested in vitro by various immunomodulatory drugs. During each sampling we will also collect 5 ml of serum on dry tube for serological constitution, 3ml on EDTA tube for performing an immunophenotyping (T, B, NK) and 3ml on EDTA tube for freezing total PBMC and setting up a biobank.

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nice - Hôpital de l'Archet	Nice	Alpes-maritimes	France	06200
2	CHU de Montpellier	Montpellier	Occitanie	France	34285
3	CHRU de Lille	Lille		France	59000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice

Investigators

• Principal Investigator: Montaudie Henri, PhD, CHU de Nice, Service de Dermatologie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT05649683
• Other Study ID Numbers: 22-PP-14
• First Posted: Dec 14, 2022
• Last Update Posted: Dec 14, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Melanoma

Study Results

No Results Posted as of Dec 14, 2022