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临床试验/NCT05649683
NCT05649683招募中不适用

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

Centre Hospitalier Universitaire de Nice6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
6
主要终点
Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the RECIST 1.1 tumoral response

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

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

结局指标

主要结局

Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the RECIST 1.1 tumoral response

时间窗: 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

次要结局

  • Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to severe immunological toxicity occurrence(Change from Baseline immunological toxicity occurrence at week 6 and at week 11)
  • Evaluation of predictifve Th1, Th2 and Th17 cytokine production correlate to the progression free(Change from Baseline disease progression at week 6 and at week 11)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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