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Studies

Interventional Recruiting

NCT05649683 on ClinicalTrials.gov

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

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

  • Sponsor: Centre Hospitalier Universitaire de Nice
  • Enrollment: 60 (Estimated)
  • Study start: 2023-01-31 (Actual)
  • Primary completion: 2027-02-01 (Estimated)
  • Study completion: 2027-06-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Other

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.

Conditions

  • Melanoma (Skin)

Intervention / Treatment

  • Biological: Evaluation of cytokine production

Primary Outcome Measures

  • 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

Countries

France

Locations and Investigators

  • CHU de Nice - Hôpital de l'Archet, Nice, France (Recruiting)
  • CHU de Montpellier, Montpellier, France (Recruiting)
  • CHRU de Lille, Lille, France (Not yet recruiting)

Study Officials