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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients treatable for HNSCC (palliative), NSCLC (separately palliative and adjuvant) or other solid tumour

• Indication for system therapy with a PD-1/PD-L1 inhibitor according to clinical standards

• Patients without or with radiation of one or more metastases

• Age at least 18 years

Locations
Other Locations
Germany
Department of Radiation Oncology, Universitätsklinikum Erlangen
RECRUITING
Erlangen
Contact Information
Primary
Markus Hecht, PD Dr.
markus.hecht@uk-erlangen.de
+49 9131 85
Backup
Benjamin Frey, PD Dr. Dr.
benjamin.frey@uk-erlangen.de
+49 9131 85
Time Frame
Start Date: 2021-04-30
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 200
Treatments
Trial cohort
The study cohort consist of patients 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 \[depending on the current drug approval\]) which will be treated with ICI (PD-1/PD-L1) and potential radiation of metastases at Department of Radiation Oncology of Universitätsklinikum Erlangen.
Sponsors
Leads: University of Erlangen-Nürnberg Medical School

This content was sourced from clinicaltrials.gov