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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    200
  • sponsor
    University of Erlangen-Nürnberg Medical School
Updated on 28 May 2021
programmed cell death 1 ligand 1
solid tumour
immunomodulator
programmed cell death protein 1

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

Details
Condition Adenocarcinoma, Esophageal Diseases, Esophageal Carcinoma, Skin Squamous Cell Carcinoma, Renal Cancer, Squamous Cell Carcinoma of Head and Neck, Malignant neoplasm of kidney, HNSCC, nsclc, oesophageal carcinoma, Kidney Cancer, Malignant Adenoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Transitional cell carcinoma, head and neck cancer, Squamous Cell Carcinoma of the Skin, squamous cell skin cancer, esophagus cancer, clear cell renal cell carcinoma, Small Cell Bronchial Carcinomas, Cutaneous Squamous Cell Carcinoma, cancer of the esophagus, Renal Cell Cancer, Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck, Esophageal Cancer, Urothelial Carcinoma, oesophageal cancer, Esophageal Disorders
Treatment Conventional Therapy acc. to prevailing clincal approved schemes
Clinical Study IdentifierNCT04892849
SponsorUniversity of Erlangen-Nürnberg Medical School
Last Modified on28 May 2021

Eligibility

Yes No Not Sure

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
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