Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy
ST-ICI02
1 other identifier
observational
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2021
CompletedStudy Start
First participant enrolled
April 30, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
September 17, 2025
September 1, 2025
7.1 years
April 26, 2021
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Overallsurvival
Prospective investigation of the survival of the patients.
From inclusion till death of subject or up to 5 years, whichever came first.
Longitudinal Immunophenotype
Longitudonal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatement.
Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Predictors in pattern recognition analyses
Identification of possible predictors in pattern recognition analyses from clinical imaging data sets.
Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Immune-associated side effects
Detection of immune-associated side effects
Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Secondary Outcomes (4)
Detection of adverse events according to NCI CTAE (v4.0)
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.
Progression free survival
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
Treatment response (according to RECIST and iRECIST criteria)
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
Attempt to establish an immune matrix of responding/non-responding patients
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.
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Melanoma patients
- Fertile patients who refuse effective contraception during study treatment
- Persistent drug and/or alcohol abuse
- Patients not able or willing to behave according to study protocol
- Patients in care
- Patients that are not able to speak German
- Patients which are imprisoned according to legal or governmental order
- Both gender are included into the study, a maximum age was not defined.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Radiation Oncology, Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Biospecimen
blood, serum, plasma, immunecell RNA, immunecell DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Markus Hecht, PD Dr.
Universitätsklinikum Erlangen, Department of Radiation Oncology
- PRINCIPAL INVESTIGATOR
Udo S Gaipl, Prof. Dr.
Universitätsklinikum Erlangen, Department of Radiation Oncology
- STUDY CHAIR
Rainer Fietkau, Prof. Dr.
Universitätsklinikum Erlangen, Department of Radiation Oncology
- PRINCIPAL INVESTIGATOR
Benjamin Frey, PD Dr. Dr.
Universitätsklinikum Erlangen, Department of Radiation Oncology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2021
First Posted
May 19, 2021
Study Start
April 30, 2021
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
December 31, 2030
Last Updated
September 17, 2025
Record last verified: 2025-09