Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Conventional Therapy acc. to prevailing clincal approved schemes: The study is observational. The treatment-plan of the underlying disease remains unchanged. The treatment of the patient is according to the prevailing clinical approved schemes at the respective entities. Blood will be drawn from patients at several time points during and after RT and ICI for detailed immunomonitoring of the patients.

Study summary

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

Eligibility

Primary outcome measure(s)

• Overallsurvival — From inclusion till death of subject or up to 5 years, whichever came first.
  Prospective investigation of the survival of the patients.
• Longitudinal Immunophenotype — 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 — 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 — 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

Trial sites (1)

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