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Spots Global Cancer Trial Database for Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy

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Trial Identification

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

Official Title: Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy in NSCLC, HNSCC and Other Solid Tumors

Study ID: NCT04892849

Study Description

Brief 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

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Department of Radiation Oncology, Universitätsklinikum Erlangen, Erlangen, Bavaria, Germany

Contact Details

Name: Markus Hecht, PD Dr.

Affiliation: Universitätsklinikum Erlangen, Department of Radiation Oncology

Role: STUDY_DIRECTOR

Name: Udo S Gaipl, Prof. Dr.

Affiliation: Universitätsklinikum Erlangen, Department of Radiation Oncology

Role: PRINCIPAL_INVESTIGATOR

Name: Rainer Fietkau, Prof. Dr.

Affiliation: Universitätsklinikum Erlangen, Department of Radiation Oncology

Role: STUDY_CHAIR

Name: Benjamin Frey, PD Dr. Dr.

Affiliation: Universitätsklinikum Erlangen, Department of Radiation Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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