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

June 3, 2024 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lille, France, 59000
        • Not yet recruiting
        • CHRU de Lille
        • Contact:
        • Sub-Investigator:
          • Mortier Laurent, PhD
    • Alpes-maritimes
      • Nice, Alpes-maritimes, France, 06200
        • Recruiting
        • CHU de Nice - Hopital De L'Archet
        • Contact:
        • Contact:
        • Principal Investigator:
          • montaudie Henri, PhD
    • Occitanie
      • Montpellier, Occitanie, France, 34285
        • Recruiting
        • CHU de Montpellier
        • Contact:
        • Sub-Investigator:
          • Dereure Olivier, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the RECIST 1.1 tumoral response
Time Frame: 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
Change from Baseline tumoral response at week 6 and at week 11

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the progression free
Time Frame: 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
Change from Baseline disease progression at week 6 and at week 11
Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to severe immunological toxicity occurrence
Time Frame: 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
Change from Baseline immunological toxicity occurrence at week 6 and at week 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 24, 2022

First Submitted That Met QC Criteria

December 5, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-PP-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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