跳至主要内容
临床试验/NCT05527795
NCT05527795招募中不适用

Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年1月1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
1,000
试验地点
1
主要终点
Duration of response to adjuvant immunotherapy according to clinical features.

研究概览

简要总结

Surgical excision is the treatment of choice for stage II, III and resectable stage IV melanoma and is curative in most cases. Given the recent success of immunotherapy for the treatment of patients with advanced metastatic melanoma, the use of immunotherapy has been evaluated in the adjuvant setting for patients at high risk of recurrence. In this context, Nivolumab prolonged Recurrence-Free Survival (RFS) while reducing toxicity compared with Ipilimumab in a phase III clinical trial, and was subsequently FDA-approved in December 2017 for adjuvant treatment of locally advanced melanoma with metastatic lymph node involvement after resection of cutaneous lesions. While a fraction of patients benefit from adjuvant PD-1 immunotherapy, approximately 40% of patients are still relapsing despite this adjuvant treatment, without being able to identify them early and with poor understanding of resistance mechanisms. Additionally, about 15% of the patients will develop serious adverse effects driven by immunotherapy and often discontinuing or even contraindicating the onset of subsequent treatments, hence affecting global patients care. It is therefore of prime importance to identify clinical features able to predict response and toxicities to adjuvant immunotherapy in melanoma.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Patients diagnosed with stage II, III or IV (resected) melanoma
  • Treated by surgery and adjuvant immunotherapy between January 1st of 2019 and January 1st of 2029
  • Gave informed consent to allow the use of biological samples for research purpose
  • Has read the information sheet regarding this study
  • With tumor samples available at the biobank center

排除标准

  • Patients under 18 years old
  • Patients placed under the judicial protection
  • Opposed to this study

结局指标

主要结局

Duration of response to adjuvant immunotherapy according to clinical features.

时间窗: 1 year

• Duration of response as defined by the time (days) between adjuvant immunotherapy onset and relapse date according to clinical features.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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