Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional Therapy acc. to prevailing clincal approved schemes.
- Who it may be relevant to
- Registry conditions: HNSCC, NSCLC, Esophageal Cancer, Urothelial Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy in NSCLC, HNSCC and Other Solid Tumors
Overview
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
Interventions
- 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.
Primary outcome measures
- Overallsurvival [Time frame: 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.]
- 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.]
- 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.]
Secondary outcome measures (4)
- 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.]
- 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]
- 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]
- 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Radiation Oncology, Universitätsklinikum Erlangen — Erlangen
Identifiers
NCT: NCT04892849 · ST-ICI02