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

Primary Purpose

Melanoma (Skin)

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of cytokine production
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Melanoma (Skin)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nice - Hôpital de l'ArchetRecruiting
  • CHU de MontpellierRecruiting
  • CHRU de Lille

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Analysis of blood cytokine

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
November 24, 2022
Last Updated
March 20, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05649683
Brief Title
Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors
Acronym
mela-quantif
Official Title
Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors - Melanoma Quantiferon
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
February 1, 2027 (Anticipated)
Study Completion Date
June 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Analysis of blood cytokine
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Evaluation of cytokine production
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the RECIST 1.1 tumoral response
Description
Analysis of blood cytokine secretion upon non specific in vitro stimulation RECIST 1.1 tumor response
Time Frame
Change from Baseline tumoral response at week 6 and at week 11
Secondary Outcome Measure Information:
Title
Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the progression free
Description
Analysis of blood cytokine secretion upon non specific in vitro stimulation disease progression
Time Frame
Change from Baseline disease progression at week 6 and at week 11
Title
Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to severe immunological toxicity occurrence
Description
Analysis of blood cytokine secretion upon non specific in vitro stimulation severe immunological toxicity occurrence
Time Frame
Change from Baseline immunological toxicity occurrence at week 6 and at week 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Montaudie Henri, PhD
Phone
33492036083
Email
montaudie.h@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pradelli Emmanuelle
Phone
33492036083
Email
pradelli.e@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Montaudie Henri, PhD
Organizational Affiliation
CHU de Nice, Service de Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - Hôpital de l'Archet
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montaudie Henri, PhD
Phone
33492036083
Email
montaudie.h@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Seitz Barbara, PhD
Email
seitz.b@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
montaudie Henri, PhD
Facility Name
CHU de Montpellier
City
Montpellier
State/Province
Occitanie
ZIP/Postal Code
34285
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dereure Olivier, PhD
Phone
33467336906
Email
o-dereure@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Dereure Olivier, PhD
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mortier Laurent, PhD
Phone
0033320444193
Email
laurent.mortier@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Mortier Laurent, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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