A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)
Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)
1 other identifier
observational
1,758
1 country
56
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Longer than P75 for all trials
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2017
CompletedFirst Posted
Study publicly available on registry
July 28, 2017
CompletedStudy Start
First participant enrolled
November 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2022
CompletedAugust 24, 2022
August 1, 2022
4.7 years
July 26, 2017
August 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Approximately 6 years
Secondary Outcomes (4)
Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Approximately 6 years
Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1
Approximately 6 years
Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1
Approximately 6 years
Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1
Approximately 6 years
Study Arms (1)
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.
Interventions
Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.
Eligibility Criteria
Participants who are administered with atezolizumab at physician's discretion will be enrolled for the study.
You may qualify if:
- Participants who are administered with atezolizumab for the locally approved indications
You may not qualify if:
- Participants with a known hypersensitivity to atezolizumab or to any of the excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Dongnam Inst.of Radiological & Medical Sciences
Busan, 46033, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Inje university Haeundae Paik Hospital
Busan, 48108, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kosin University Gospel Hospital
Busan, 49267, South Korea
Donga Uni Medical Center; Pulmonary
Busan, 602-715, South Korea
Pusan University Hospital
Busan, 602-739, South Korea
Pusan University Hospital; Hemato-oncology
Busan, South Korea
Kyungpook National University Medical Center
Daegu, 41404, South Korea
Keimyung University Dongsan Medical Center
Daegu, 41931, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
Keimyung University Dongsan Hospital; Pulmonology
Daegu, 42601, South Korea
Konyang University Hospital
Daejeon, 35365, South Korea
Hallym University Medical Center Chuncheon Sacred Heart Hospital
Gangwon-do, 24253, South Korea
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, 26426, South Korea
Gangneung Asan Hospital
Gangwon-do, South Korea
Uijeongbu St. Mary's Hospital
Gyeonggi-do, 11765, South Korea
CHA Bundang Medical Center
Gyeonggi-do, 13496, South Korea
Hallym University Sacred Heart Hospital
Gyeonggi-do, 14068, South Korea
Soonchunhyang University Bucheon Hospital
Gyeonggi-do, 14584, South Korea
Bucheon St Mary's hospital
Gyeonggi-do, 14647, South Korea
Korea University Ansan Hospital
Gyeonggi-do, 15355, South Korea
St. Vincent's Hospital
Gyeonggi-do, 16247, South Korea
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, South Korea
Chonbuk National University Hospital
Jeollabuk-do, 54907, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Wonkwang University School of Medicine & Hospital
Jeonlabuk-do, 54538, South Korea
Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
Seoul, 01812, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Eunpyeong St. Mary's Hoapital
Seoul, 03312, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Severance Hospital, Yonsei University
Seoul, 03722, South Korea
Soonchunhyang University Hospital
Seoul, 04401, South Korea
Hanyang University Medical Center
Seoul, 04763, South Korea
Gangdong Kyung Hee University Hospital
Seoul, 05278, South Korea
VHS Medical Center
Seoul, 05368, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul St Mary's Hospital
Seoul, 06591, South Korea
ChungAng University Hospital
Seoul, 06973, South Korea
Borame Medical Center
Seoul, 07061, South Korea
Yeouido St. Mary's Hospital
Seoul, 07345, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Severance Hospital, Yonsei University Health System; Oncology
Seoul, 120-752, South Korea
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, 135-710, South Korea
Ewha Womans University Mokdong Hospital; Urology
Seoul, South Korea
Korea Uni Anam Hospital; Internal Medicine
Seoul, South Korea
SoonChunHyang University Hospital Seoul
Seoul, South Korea
Ulsan University Hosiptal
Ulsan, 44033, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220-701, South Korea
Pusan National University Yangsan Hospital; hemato-oncology
Yangsan, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2017
First Posted
July 28, 2017
Study Start
November 29, 2017
Primary Completion
August 12, 2022
Study Completion
August 12, 2022
Last Updated
August 24, 2022
Record last verified: 2022-08