NCT04892849 Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy
| NCT ID | NCT04892849 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | HNSCC |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-04-30 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-04-30 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Markus Hecht, PD Dr.
STUDY DIRECTOR
Universitätsklinikum Erlangen, Department of Radiation Oncology
Frequently Asked Questions
Who can join the NCT04892849 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HNSCC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04892849 currently recruiting?
Yes, NCT04892849 is actively recruiting participants. Contact the research team at markus.hecht@uk-erlangen.de for enrollment information.
Where is the NCT04892849 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT04892849 clinical trial?
NCT04892849 is sponsored by University of Erlangen-Nürnberg Medical School. The principal investigator is Markus Hecht, PD Dr. at Universitätsklinikum Erlangen, Department of Radiation Oncology. The trial plans to enroll 200 participants.