A Prospective, Observational, Multicenter Clinical Performance Study to Evaluate IOpener®-melanoma Test for Predicting Response to Combination or Mono Immunotherapy in Stage III or IV Cutaneous Melanoma Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 3
- 主要终点
- 12 months Progression Free Survival rate
研究概览
简要总结
The goal of this observational study is to assess whether the IOpener® melanoma test can assist treating physicians in deciding which therapy is most suitable for patients with skin cancer (advanced cutaneous melanoma). For this purpose it is evaluated how well the IOpener-melanoma test can predict the result of cancer treatment in the treatment groups (standard of care anti-PD1 mono-therapy and standard of care anti-PD1 + anti-CTLA-4 therapy).
Participants will be asked to provide blood sample for analysis using IOpener®-melanoma test. Patients will receive regular medical care, the test results will not be used to make any treatment decisions. The patients will visit the clinic for treatment administration and clinical evaluation as part of their regular medical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •First line treatment for unresectable stage III or IV cutaneous melanoma (according to AJCC version 8) with anti-PD1 monotherapy (nivolumab or pembrolizumab) or anti-PD1 + anti-CTL4A combination therapy (nivolumab and ipilimumab).
- •Anticipated life expectancy exceeding 3 months.
- •Aged 18 years or older and able to provide written informed consent.
- •Patients who have completed adjuvant treatment with anti-PD1 immunotherapy at least 6 months ago can be included.
排除标准
- •Prior treatment for irresectable stage III or stage IV melanoma with BRAF/MEK inhibitors.
- •Presence of progressive/symptomatic brain metastases at baseline.
- •WHO performance score ≥
- •Adjuvant treatment with anti-PD1 immunotherapy received within the last 6 months.
- •Patients undergoing experimental treatments or therapies.
- •Presence of any medical or other condition that in the opinion of the investigator(s) would preclude the participation in a clinical study.
- •Unwillingness or inability to comply with study and follow-up procedures.
结局指标
主要结局
12 months Progression Free Survival rate
时间窗: From the enrollment to 12 months follow up.
Predictive value of IOpener-melanoma for 1-year Progression Free Survival (PFS), i.e., proportion of patients without progressive disease (PD) ≥ 1 year, stratified according to treatment group and IOpener-melanoma test result.
次要结局
- Overall Response Rate (ORR) at 1 year(From enrollment to 12 months follow up.)
- Disease Control Rate at 1 year(From enrollment to 12 months follow up.)
- Progression Free Survival(From enrollment to month 24 follow up.)
- Overall Survival(From enrollment to month 24 follow up.)