NCT Number: NCT04892849
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Erlangen, Bavaria, 91054, Germany
Location status: Recruiting
Anna Donaubauer, M.Sc.
CONTACT
+49 9131 85 ext. 32311
Benjamin Frey, Dr.-Ing.
CONTACT
+49 9131 85 ext. 44248
Markus Hecht, M.D.
PRINCIPAL_INVESTIGATOR
Rainer Fietkau, Prof. Dr.
PRINCIPAL_INVESTIGATOR
Udo S Gaipl, Prof. Dr.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Both gender are included into the study, a maximum age was not defined.
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.
Time frame: From inclusion till death of subject or up to 5 years, whichever came first.
Prospective investigation of the survival of the patients.
Time frame: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Longitudonal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatement.
Time frame: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Identification of possible predictors in pattern recognition analyses from clinical imaging data sets.
Time frame: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Detection of immune-associated side effects
Time frame: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, or till change to conventional treatment , whichever came first, assessed up to 5 years.
The adverse effects of Immunecheckpoint and Radiotherapy is recorded by official questionaire
Time frame: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to 5 yeras
survival of the patient without progression of malignant disesase
Time frame: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to 5 years
RECIST and iRECIST criteria will used to analyse the response of the patient to the respective treatement
Time frame: The analyses are conducted at time points before (day 0) and before every prescription of ICI (every 14 to 21 days) till progression or end of study up to 5 years or till change to conventional treatment without ICI.
Analysis of clincal, MRI and imunnologic, molecular data to develop an biomarkermatrix with processes of machine learning
Contact information is provided by the study sponsor or research team.
Benjamin Frey, PD Dr. Dr.
CONTACT
+49 9131 85 ext. 44248
Markus Hecht, PD Dr.
CONTACT
+49 9131 85 ext. 44247
University of Erlangen-Nürnberg Medical School
Other
Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy in NSCLC, HNSCC and Other Solid Tumors
Acronym: ST-ICI02
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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