Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-08 @ 9:51 AM
Study NCT ID:
NCT03453892
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2018-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, Plasma, Blood cells, circulating DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic (according to iRECIST criteria) and local response of detected metastases during radio and/or immunotherapy.', 'timeFrame': '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 day 540.'}, {'measure': 'Change of circulating immune cells of treated patients by deep immunophenotyping.', 'timeFrame': '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 at day 540', 'description': 'Immunophenotyping of the patients: Detection of about 30 distinct immune sell (sub)types together with their activation markers. 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 at day 540.'}], 'secondaryOutcomes': [{'measure': 'Detection of adverse events according to NCI CTAE (v4.0)', 'timeFrame': '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 day 540.'}, {'measure': 'Documentation of corticoid prescription', 'timeFrame': '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 day 540.'}, {'measure': 'Overall survival', 'timeFrame': 'Till death of the patient or end of study at day 540, whichever came first'}, {'measure': 'Progression free survival', 'timeFrame': '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 day 540.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic cancer', 'Radiotherapy', 'Immunotherapy', 'radioimmuno therapy'], 'conditions': ['Metastatic Cancer']}, 'referencesModule': {'references': [{'pmid': '33761922', 'type': 'DERIVED', 'citation': 'Griewing LM, Schweizer C, Schubert P, Rutzner S, Eckstein M, Frey B, Haderlein M, Weissmann T, Semrau S, Gostian AO, Muller SK, Traxdorf M, Iro H, Zhou JG, Gaipl US, Fietkau R, Hecht M. Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors. BMC Cancer. 2021 Mar 24;21(1):314. doi: 10.1186/s12885-021-08006-0.'}, {'pmid': '33593828', 'type': 'DERIVED', 'citation': 'Zhou JG, Donaubauer AJ, Frey B, Becker I, Rutzner S, Eckstein M, Sun R, Ma H, Schubert P, Schweizer C, Fietkau R, Deutsch E, Gaipl U, Hecht M. Prospective development and validation of a liquid immune profile-based signature (LIPS) to predict response of patients with recurrent/metastatic cancer to immune checkpoint inhibitors. J Immunother Cancer. 2021 Feb;9(2):e001845. doi: 10.1136/jitc-2020-001845.'}]}, 'descriptionModule': {'briefSummary': 'Immunotherapy for the treatment of several cancer entities steadily increased during the last years. The data from the finalized and ongoing studies show the tremendous impact of immune checkpoint inhibition (ICI) also for advanced metastatic patients. Especially the ICI with pembrolizumab and nivolumab have an increasing number of first line treatment approvals. However, in particular metastatic patients which receive ICI therapy are often irradiated for immediate palliation of several metastases. Preclinical work revealed that radiotherapy (RT) is capable to modulate the tumor phenotype, its microenvironment in a way that systemic anti-tumor immune responses are induced. However, radiation has also immune suppressive properties as e.g. the expression of immune checkpoint molecules is increased following radiotherapy. So the ICI therapy in combination with the RT has the potential to overcome the immunotolerance of the tumor and the metastases. More and more reports therefore describe a so-called systemic immune-modulating effect of radiotherapy (former and still often named as abscopal effect). However the timely application of ICI and RT is often randomly and depends on the clinical need for the palliative RT. The aim of this trial is therefore to standardize the chronology of RT in combination with ICI, to evaluate the effects of radio-immunotherapy with a stratified and comparable patient cohort. The ST-ICI study is a prospective and observational study not influencing the standard therapeutic scheme and will provide hints how the radio-immune therapy drives systemic anti tumor responses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study cohort consist of patients suffering from metastatic cancer of several entities which will be treated with optionally RT (if indicated) and/or ICI at Department of Radiation Oncology of Universitätsklinikum Erlangen.\n\nBoth gender are included into the study, a maximum age was not defined.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering and diagnosed for: metastatic cancer of several entities\n* Clinical indicated therapy with PD-1/PD-L1 inhibitors or CTLA-4 antagonists\n* Optionally radiotherapy if clinically indicated\n* Age at least 18 years\n\nExclusion Criteria:\n\n* fertile patients who refuse effective contraception during study treatment\n* persistent drug and/or alcohol abuse\n* patients not able or willing to behave according to study protocol\n* patients in care\n* patients that are not able to speak German\n* patients which are imprisoned according to legal or governmental order'}, 'identificationModule': {'nctId': 'NCT03453892', 'acronym': 'ST-ICI', 'briefTitle': 'Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition', 'orgStudyIdInfo': {'id': 'ST-ICI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'anti CTLA-4', 'description': 'The study cohort consist of patients suffering from metastatic cancer of several entities which will be treated with palliative RT and/or ICI (anti CTLA-4) at Department of Radiation Oncology of Universitätsklinikum Erlangen.', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: Ipilimumab']}, {'label': 'anti PD-1/PD-L1', 'description': 'The study cohort consist of patients suffering from metastatic cancer of several entities which will be treated with palliative RT and/or ICI (anti PD-1/PD-L1) at Department of Radiation Oncology of Universitätsklinikum Erlangen.', 'interventionNames': ['Drug: Nivolumab', 'Drug: Pembrolizumab', 'Radiation: Radiotherapy']}], 'interventions': [{'name': 'Nivolumab', 'type': 'DRUG', 'description': 'The normal clinical treatment-plan of the underlying disease remains unchanged.', 'armGroupLabels': ['anti PD-1/PD-L1']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'The normal clinical treatment-plan of the underlying disease remains unchanged.', 'armGroupLabels': ['anti PD-1/PD-L1']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'The normal clinical treatment-plan of the underlying disease remains unchanged.', 'armGroupLabels': ['anti CTLA-4', 'anti PD-1/PD-L1']}, {'name': 'Ipilimumab', 'type': 'DRUG', 'description': 'The normal clinical treatment-plan of the underlying disease remains unchanged.', 'armGroupLabels': ['anti CTLA-4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Radiation Oncology, Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Rainer Fietkau, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Radiation Oncology, Universitätsklinikum Erlangen'}, {'name': 'Markus Hecht, Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Radiation Oncology, Universitätsklinikum Erlangen'}, {'name': 'Udo S Gaipl, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Radiation Oncology, Universitätsklinikum Erlangen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}