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

NCT ID: NCT04892849

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2030-12-31

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

Conditions

HNSCC; NSCLC; Esophageal Cancer; Urothelial Carcinoma; Renal Cell Carcinoma; Squamous Cell Carcinoma of the Skin; Small Cell Bronchial Carcinomas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Conventional Therapy acc. to prevailing clincal approved schemes

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Hecht, PD Dr.

Role: STUDY_DIRECTOR

Universitätsklinikum Erlangen, Department of Radiation Oncology

Udo S Gaipl, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Erlangen, Department of Radiation Oncology

Rainer Fietkau, Prof. Dr.

Role: STUDY_CHAIR

Universitätsklinikum Erlangen, Department of Radiation Oncology

Benjamin Frey, PD Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Erlangen, Department of Radiation Oncology

Locations

Department of Radiation Oncology, Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Markus Hecht, PD Dr.

Role: CONTACT

markus.hecht@uk-erlangen.de

+49 9131 85 ext. 44247

Benjamin Frey, PD Dr. Dr.

Role: CONTACT

benjamin.frey@uk-erlangen.de

+49 9131 85 ext. 44248

Facility Contacts

Benjamin Frey, Dr.-Ing.

Role: primary

benjamin.frey@uk-erlangen.de

+49 9131 85 ext. 44248

Anna Donaubauer, M.Sc.

Role: backup

anna-jasmina.donaubauer@uk-erlangen.de

+49 9131 85 ext. 32311

Other Identifiers

ST-ICI02

Identifier Type: -

Identifier Source: org_study_id