A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)

NCT ID: NCT03232593

Last Updated: 2022-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1758 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-29

Study Completion Date

2022-08-12

Brief Summary

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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.

Detailed Description

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Conditions

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Urothelial Carcinoma Carcinoma, Non-Small Cell Lung Small Cell Lung Carcinoma Triple Negative Breast Carcinoma Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants who Receive Atezolizumab

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.

Atezolizumab

Intervention Type DRUG

Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.

Interventions

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Atezolizumab

Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.

Intervention Type DRUG

Other Intervention Names

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Tecentriq

Eligibility Criteria

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Inclusion Criteria

* Participants who are administered with atezolizumab for the locally approved indications

Exclusion Criteria

* Participants with a known hypersensitivity to atezolizumab or to any of the excipients
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Dongnam Inst.of Radiological & Medical Sciences

Busan, , South Korea

Site Status

Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Inje university Haeundae Paik Hospital

Busan, , South Korea

Site Status

Dong-A University Hospital

Busan, , South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Donga Uni Medical Center; Pulmonary

Busan, , South Korea

Site Status

Pusan University Hospital

Busan, , South Korea

Site Status

Pusan University Hospital; Hemato-oncology

Busan, , South Korea

Site Status

Kyungpook National University Medical Center

Daegu, , South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Keimyung University Dongsan Hospital; Pulmonology

Daegu, , South Korea

Site Status

Konyang University Hospital

Daejeon, , South Korea

Site Status

Hallym University Medical Center Chuncheon Sacred Heart Hospital

Gangwon-do, , South Korea

Site Status

Yonsei University Wonju Severance Christian Hospital

Gangwon-do, , South Korea

Site Status

Gangneung Asan Hospital

Gangwon-do, , South Korea

Site Status

Uijeongbu St. Mary's Hospital

Gyeonggi-do, , South Korea

Site Status

CHA Bundang Medical Center

Gyeonggi-do, , South Korea

Site Status

Hallym University Sacred Heart Hospital

Gyeonggi-do, , South Korea

Site Status

Soonchunhyang University Bucheon Hospital

Gyeonggi-do, , South Korea

Site Status

Bucheon St Mary's hospital

Gyeonggi-do, , South Korea

Site Status

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

Site Status

St. Vincent's Hospital

Gyeonggi-do, , South Korea

Site Status

Pusan National University Yangsan Hospital

Gyeongsangnam-do, , South Korea

Site Status

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, , South Korea

Site Status

Chonbuk National University Hospital

Jeollabuk-do, , South Korea

Site Status

Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

Site Status

Wonkwang University School of Medicine & Hospital

Jeonlabuk-do, , South Korea

Site Status

Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Eunpyeong St. Mary's Hoapital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University

Seoul, , South Korea

Site Status

Soonchunhyang University Hospital

Seoul, , South Korea

Site Status

Hanyang University Medical Center

Seoul, , South Korea

Site Status

Gangdong Kyung Hee University Hospital

Seoul, , South Korea

Site Status

VHS Medical Center

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul St Mary's Hospital

Seoul, , South Korea

Site Status

ChungAng University Hospital

Seoul, , South Korea

Site Status

Borame Medical Center

Seoul, , South Korea

Site Status

Yeouido St. Mary's Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System; Oncology

Seoul, , South Korea

Site Status

Samsung Medical Centre; Division of Hematology/Oncology

Seoul, , South Korea

Site Status

Ewha Womans University Mokdong Hospital; Urology

Seoul, , South Korea

Site Status

Korea Uni Anam Hospital; Internal Medicine

Seoul, , South Korea

Site Status

SoonChunHyang University Hospital Seoul

Seoul, , South Korea

Site Status

Ulsan University Hosiptal

Ulsan, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Yonsei University Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status

Pusan National University Yangsan Hospital; hemato-oncology

Yangsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ML39313

Identifier Type: -

Identifier Source: org_study_id

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