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NCT Number: NCT05649683

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice - Hôpital de l'Archet, Nice, Alpes-maritimes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of cytokine production

Biological

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Montaudie Henri, PhD

CONTACT

[email protected]

33492036083

Pradelli Emmanuelle

CONTACT

[email protected]

33492036083

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: mela-quantif

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 14, 2022
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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