Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-02 @ 11:57 PM
Study NCT ID:
NCT03232593
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1758}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-07-26', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)', 'timeFrame': 'Approximately 6 years'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Approximately 6 years'}, {'measure': 'Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1', 'timeFrame': 'Approximately 6 years'}, {'measure': 'Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1', 'timeFrame': 'Approximately 6 years'}, {'measure': 'Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1', 'timeFrame': 'Approximately 6 years'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urothelial Carcinoma', 'Carcinoma, Non-Small Cell Lung', 'Small Cell Lung Carcinoma', 'Triple Negative Breast Carcinoma', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the drug label approved by the MFDS in Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants who are administered with atezolizumab at physician's discretion will be enrolled for the study.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who are administered with atezolizumab for the locally approved indications\n\nExclusion Criteria:\n\n* Participants with a known hypersensitivity to atezolizumab or to any of the excipients'}, 'identificationModule': {'nctId': 'NCT03232593', 'briefTitle': 'A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)', 'orgStudyIdInfo': {'id': 'ML39313'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants who Receive Atezolizumab', 'description': "Participants who are administered with atezolizumab as per the local label and standard of care at physician's discretion will be observed for approximately 6 years.", 'interventionNames': ['Drug: Atezolizumab']}], 'interventions': [{'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['Tecentriq'], 'description': "Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.", 'armGroupLabels': ['Participants who Receive Atezolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46033', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dongnam Inst.of Radiological & Medical Sciences', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '47392', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48108', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje university Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49201', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49267', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '602-715', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Donga Uni Medical Center; Pulmonary', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '602-739', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan University Hospital; Hemato-oncology', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '41404', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '41931', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42472', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42601', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital; Pulmonology', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '35365', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Konyang University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '24253', 'city': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Hallym University Medical Center Chuncheon Sacred Heart Hospital'}, {'zip': '26426', 'city': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Yonsei University Wonju Severance Christian Hospital'}, {'city': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Gangneung Asan Hospital'}, {'zip': '11765', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "Uijeongbu St. Mary's Hospital", 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '13496', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'CHA Bundang Medical Center', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '14068', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '14584', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Soonchunhyang University Bucheon Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '14647', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "Bucheon St Mary's hospital", 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '15355', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '16247', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '50612', 'city': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital'}, {'city': 'Hwaseong-si', 'country': 'South Korea', 'facility': 'Hallym University Dongtan Sacred Heart Hospital', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}, {'zip': '54907', 'city': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital'}, {'zip': '58128', 'city': 'Jeollanam-do', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital'}, {'zip': '54538', 'city': 'Jeonlabuk-do', 'country': 'South Korea', 'facility': 'Wonkwang University School of Medicine & Hospital'}, {'zip': '01812', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03312', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Eunpyeong St. Mary's Hoapital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04401', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04763', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05278', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangdong Kyung Hee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05368', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'VHS Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06273', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06973', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'ChungAng University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Borame Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07345', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Yeouido St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System; Oncology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Centre; Division of Hematology/Oncology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital; Urology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea Uni Anam Hospital; Internal Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'SoonChunHyang University Hospital Seoul', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '44033', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hosiptal', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'zip': '44033', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'zip': '220-701', 'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Yonsei University Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital; hemato-oncology', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}