Clinical trial · Observational
Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy
Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy in NSCLC, HNSCC and Other Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Small Cell Bronchial Carcinomas | — | UNRESOLVED | — |
| Squamous Cell Carcinoma of the Skin | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Therapy acc. to prevailing clincal approved schemes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Other: Conventional Therapy acc. to prevailing clincal approved schemes
Primary outcomes (4)
- measure
- Overallsurvival
- timeFrame
- From inclusion till death of subject or up to 5 years, whichever came first.
- description
- Prospective investigation of the survival of the patients.
- measure
- Longitudinal Immunophenotype
- timeFrame
- Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available