Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy in NSCLC, HNSCC and Other Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overallsurvival
研究概览
简要总结
Inhibitors of the programmed cell death protein 1 (PD-1)/PD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Different exploratory trials suggest that the combination of radiotherapy and PD-1/PD-L1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. In addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. First data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. During the planned STICI-02 trial predictive immune matrix derived from the STICI01 trial (NCT03453892) will be validated in the groups of patient suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]). Within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. The side effects
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
- •Patients treatable for HNSCC (palliative), NSCLC (separately palliative and adjuvant) or "other solid tumour"
- •Indication for system therapy with a PD-1/PD-L1 inhibitor according to clinical standards
- •Patients without or with radiation of one or more metastases
- •Age at least 18 years
排除标准
- •Melanoma patients
- •Fertile patients who refuse effective contraception during study treatment
- •Persistent drug and/or alcohol abuse
- •Patients not able or willing to behave according to study protocol
- •Patients in care
- •Patients that are not able to speak German
- •Patients which are imprisoned according to legal or governmental order
- •Both gender are included into the study, a maximum age was not defined.
结局指标
主要结局
Overallsurvival
时间窗: From inclusion till death of subject or up to 5 years, whichever came first.
Prospective investigation of the survival of the patients.
Longitudinal Immunophenotype
时间窗: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Longitudonal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatement.
Predictors in pattern recognition analyses
时间窗: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Identification of possible predictors in pattern recognition analyses from clinical imaging data sets.
Immune-associated side effects
时间窗: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Detection of immune-associated side effects
次要结局
- Treatment response (according to RECIST and iRECIST criteria)(From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Progression free survival(From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to 5 yeras)
- Detection of adverse events according to NCI CTAE (v4.0)(From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, or till change to conventional treatment , whichever came first, assessed up to 5 years.)
- Attempt to establish an immune matrix of responding/non-responding patients(The analyses are conducted at time points before (day 0) and before every prescription of ICI (every 14 to 21 days) till progression or end of study up to 5 years or till change to conventional treatment without ICI.)