Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy (ST-ICI02)

September 10, 2025 updated by: University of Erlangen-Nürnberg Medical School

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Department of Radiation Oncology, Universitätsklinikum Erlangen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Markus Hecht, M.D.
        • Principal Investigator:
          • Udo S Gaipl, Prof. Dr.
        • Principal Investigator:
          • Rainer Fietkau, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Conventional Therapy acc. to prevailing clincal approved schemes
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overallsurvival
Time Frame: From inclusion till death of subject or up to 5 years, whichever came first.
Prospective investigation of the survival of the patients.
From inclusion till death of subject or up to 5 years, whichever came first.
Longitudinal Immunophenotype
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.
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
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.
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
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
Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of adverse events according to NCI CTAE (v4.0)
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
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
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
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)
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
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
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2021

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-ICI02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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