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

NCT04892849 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-09-17

No results posted yet for this 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

Conditions

Interventions

OTHER

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.

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Markus Hecht, PD Dr. · Universitätsklinikum Erlangen, Department of Radiation Oncology

  • Udo S Gaipl, Prof. Dr. · Universitätsklinikum Erlangen, Department of Radiation Oncology

  • Rainer Fietkau, Prof. Dr. · Universitätsklinikum Erlangen, Department of Radiation Oncology

  • Benjamin Frey, PD Dr. Dr. · Universitätsklinikum Erlangen, Department of Radiation Oncology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2028-05-31
Completion
2030-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04892849 on ClinicalTrials.gov