Neoplasms

Digestive System Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Esophageal Neoplasms

Carcinoma

Carcinoma, Transitional Cell

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Carcinoma, Bronchogenic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Esophageal Cancer

Transitional Cell Carcinoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Immunomodulating Agents

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.

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.

Conventional Therapy acc. to prevailing clincal approved schemes

Markus Hecht, PD Dr.

Benjamin Frey, PD Dr. Dr.

Benjamin Frey, Dr.-Ing.

Anna Donaubauer, M.Sc.

Markus Hecht, M.D.

Udo S Gaipl, Prof. Dr.

Rainer Fietkau, Prof. Dr.

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

blood, serum, plasma, immunecell RNA, immunecell DNA

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

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

Prospective investigation of the survival of the patients.

Longitudonal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatement.

Identification of possible predictors in pattern recognition analyses from clinical imaging data sets.

Detection of immune-associated side effects

The adverse effects of Immunecheckpoint and Radiotherapy is recorded by official questionaire

survival of the patient without progression of malignant disesase

RECIST and iRECIST criteria will used to analyse the response of the patient to the respective treatement

Analysis of clincal, MRI and imunnologic, molecular data to develop an biomarkermatrix with processes of machine learning

University of Erlangen-Nürnberg Medical School

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy	NCT04892849	HNSCC NSCLC Esophageal Canc... Urothelial Carc... Renal Cell Carc... Squamous Cell C... Small Cell Bron...	Conventional Th...	18 Years -	University of Erlangen-Nürnberg Medical School
Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy	NCT04892849	HNSCC NSCLC Esophageal Canc... Urothelial Carc... Renal Cell Carc... Squamous Cell C... Small Cell Bron...	Conventional Th...	18 Years -	University of Erlangen-Nürnberg Medical School

Spots Global Cancer Trial Database for conventional therapy acc. to prevailing clincal approved schemes