Multi-centre, Retrospective, Open Label Study, to Establish and Validate ML-PrediCare for Patients of Advanced Melanoma Undergoing Immunotherapy, as a 1st, 2nd and Later Lines
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The primary endpoint in this study stage is Time to Progression of disease
研究概览
简要总结
This is a retrospective, open label study to establish and validate a prediction technology for advanced melanoma patients under the 1st, 2nd and later treatment lines, with the immunotherapeutic drugs Ipilimumab, Pembrolizumab & Nivolumab, in order to predict response rate and disease progression
详细描述
The aim of this project is to develop a technology application (termed ML-PrediCare), which is meant to be a predictive stand-alone software device, to support clinicians' decision-making, by predicting the individual patient's response to immunotherapy treatments, e.g., in terms of time-to-progression (TTP).
In Stage I of the study, data will be collected for establishing a training set and assess the predictive potential of the modelling technology for the response of melanoma patients to immunotherapy. In Stage II of the study, data will be collected in order to establish a validation set and test the predictive power of the modelling technology in an independent set of patients diagnosed with melanoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all of the following criteria are eligible for this study:
- •Gender: Female, Male.
- •Age: Eighteen years and older at the start of treatment.
- •Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system.
- •Prior radiotherapy must have been completed at least 2 weeks prior to drug administration.
- •Measurable disease by CT, or PET-CT, or MRI per RECIST 1.1
- •Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) before treatment.
- •Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) during or after the treatment.
- •Patient has at least one recorded visit to the treating oncologist before treatment.
- •Patient has at least one recorded visit to the treating oncologist during or after the treatment.
- •Treatment as per SOC for melanoma.
排除标准
- •Patients meeting one or more of the following criteria are ineligible for this study:
- •History of another malignancy within the previous 2 years except for:
- •Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years
- •Ocular melanoma
- •Active brain metastases or leptomeningeal metastases.
结局指标
主要结局
The primary endpoint in this study stage is Time to Progression of disease
时间窗: 1 year
次要结局
未报告次要终点