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

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат 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

Первичные конечные точки

• Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the RECIST 1.1 tumoral response [Срок оценки: Change from Baseline tumoral response at week 6 and at week 11]

Вторичные конечные точки (2)

• Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the progression free [Срок оценки: 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 [Срок оценки: Change from Baseline immunological toxicity occurrence at week 6 and at week 11]

Критерии участия

Inclusion

• persone of major age,
• advanced melanoma confirmed,
• RECIST 1.1 disease,
• first line treatment

Критерии исключения

• occular and mucosal melanoma,
• previous checkpoint inhibitor treatment,
• active brain metastasis,
• concomitant immunosuppressive treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 3 центра

• CHU de Nice - Hôpital de l'Archet — Nice
• CHU de Montpellier — Montpellier
• CHRU de Lille — Lille

Идентификаторы

NCT: NCT05649683 · 22-PP-14

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗