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

University of Erlangen-Nürnberg Medical School

Status: Enrolling

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

Treatments: Other: Conventional Therapy acc. to prevailing clincal approved schemes

Study type: Observational

Funder types: Other

Identifiers

NCT04892849

ST-ICI02

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Trial cohort

Description:

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.

Treatment:

Other: Conventional Therapy acc. to prevailing clincal approved schemes