Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05649683

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

Led by Centre Hospitalier Universitaire de Nice · Updated on 2024-06-04

60

Participants Needed

3

Research Sites

226 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Person of major age
  • Confirmed advanced melanoma
  • Disease measurable by RECIST 1.1 criteria
  • First line treatment for melanoma
Not Eligible

You will not qualify if you...

  • Ocular and mucosal melanoma
  • Previous treatment with checkpoint inhibitors
  • Active brain metastasis
  • Use of concomitant immunosuppressive treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-maritimes, France, 06200

Actively Recruiting

2

CHU de Montpellier

Montpellier, Occitanie, France, 34285

Actively Recruiting

3

CHRU de Lille

Lille, France, 59000

Not Yet Recruiting

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Research Team

M

Montaudie Henri, PhD

CONTACT

P

Pradelli Emmanuelle

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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