The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Radiation Oncology, Universitätsklinikum Erlangen, Erlangen, Bavaria, Germany
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