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Study identifier: NCT04892849 Synced from ClinicalTrials.gov · July 28, 2026
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Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy

Condition: HNSCC · NSCLC · Esophageal Cancer  ·  Sponsor: University of Erlangen-Nürnberg Medical School

PhaseN/A
Planned participants200
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Markus Hecht, PD Dr.  ·  +49 9131 85  ·  markus.hecht@uk-erlangen.de

Benjamin Frey, PD Dr. Dr.  ·  +49 9131 85  ·  benjamin.frey@uk-erlangen.de

Always discuss trial participation with your own doctor first.

Locations (1)

Department of Radiation Oncology, Universitätsklinikum ErlangenErlangen, Bavaria, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT04892849