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

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ClinicalTrials.gov Identifier: NCT04892849
Recruitment Status : Recruiting
First Posted : May 19, 2021
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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

Condition or disease Intervention/treatment
HNSCC NSCLC Esophageal Cancer Urothelial Carcinoma Renal Cell Carcinoma Squamous Cell Carcinoma of the Skin Small Cell Bronchial Carcinomas Other: Conventional Therapy acc. to prevailing clincal approved schemes

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : May 31, 2026
Estimated Study Completion Date : December 31, 2027


Group/Cohort Intervention/treatment
Trial cohort
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.
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 :
  1. Overallsurvival [ Time Frame: From inclusion till death of subject or up to 5 years, whichever came first. ]
    Prospective investigation of the survival of the patients.

  2. 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. ]
    Longitudonal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatement.

  3. 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. ]
    Identification of possible predictors in pattern recognition analyses from clinical imaging data sets.

  4. 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. ]
    Detection of immune-associated side effects


Secondary Outcome Measures :
  1. 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. ]
    The adverse effects of Immunecheckpoint and Radiotherapy is recorded by official questionaire

  2. 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 ]
    survival of the patient without progression of malignant disesase

  3. 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 ]
    RECIST and iRECIST criteria will used to analyse the response of the patient to the respective treatement

  4. 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. ]
    Analysis of clincal, MRI and imunnologic, molecular data to develop an biomarkermatrix with processes of machine learning


Biospecimen Retention:   Samples With DNA
blood, serum, plasma, immunecell RNA, immunecell DNA


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04892849


Contacts
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Contact: Markus Hecht, PD Dr. +49 9131 85 ext 44247 markus.hecht@uk-erlangen.de
Contact: Benjamin Frey, PD Dr. Dr. +49 9131 85 ext 44248 benjamin.frey@uk-erlangen.de

Locations
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Germany
Department of Radiation Oncology, Universitätsklinikum Erlangen Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Benjamin Frey, Dr.-Ing.    +49 9131 85 ext 44248    benjamin.frey@uk-erlangen.de   
Contact: Anna Donaubauer, M.Sc.    +49 9131 85 ext 32311    anna-jasmina.donaubauer@uk-erlangen.de   
Principal Investigator: Markus Hecht, M.D.         
Principal Investigator: Udo S Gaipl, Prof. Dr.         
Principal Investigator: Rainer Fietkau, Prof. Dr.         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Study Director: Markus Hecht, PD Dr. Universitätsklinikum Erlangen, Department of Radiation Oncology
Principal Investigator: Udo S Gaipl, Prof. Dr. Universitätsklinikum Erlangen, Department of Radiation Oncology
Study Chair: Rainer Fietkau, Prof. Dr. Universitätsklinikum Erlangen, Department of Radiation Oncology
Principal Investigator: Benjamin Frey, PD Dr. Dr. Universitätsklinikum Erlangen, Department of Radiation Oncology
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT04892849    
Other Study ID Numbers: ST-ICI02
First Posted: May 19, 2021    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Immunotherapy
Radiotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Carcinoma, Bronchogenic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases