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

August 23, 2022 updated by: Hoffmann-La Roche

Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1758

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Busan, Korea, Republic of, 47392
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of, 46033
        • Dongnam Inst.of Radiological & Medical Sciences
      • Busan, Korea, Republic of, 602-715
        • Donga Uni Medical Center; Pulmonary
      • Busan, Korea, Republic of, 602-739
        • Pusan University Hospital
      • Busan, Korea, Republic of
        • Pusan University Hospital; Hemato-oncology
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Medical Center
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of, 42601
        • Keimyung University Dongsan Hospital; Pulmonology
      • Daejeon, Korea, Republic of, 35365
        • Konyang University Hospital
      • Gangwon-do, Korea, Republic of, 26426
        • Yonsei University Wonju Severance Christian Hospital
      • Gangwon-do, Korea, Republic of, 24253
        • Hallym University Medical Center Chuncheon Sacred Heart Hospital
      • Gangwon-do, Korea, Republic of
        • Gangneung Asan Hospital
      • Gyeonggi-do, Korea, Republic of, 15355
        • Korea University Ansan Hospital
      • Gyeonggi-do, Korea, Republic of, 13496
        • CHA Bundang Medical Center
      • Gyeonggi-do, Korea, Republic of, 16247
        • St. Vincent's Hospital
      • Gyeonggi-do, Korea, Republic of, 11765
        • Uijeongbu St. Mary's Hospital
      • Gyeonggi-do, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Gyeonggi-do, Korea, Republic of, 14584
        • Soonchunhyang University Bucheon Hospital
      • Gyeonggi-do, Korea, Republic of, 14647
        • Bucheon St Mary's Hospital
      • Gyeongsangnam-do, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
      • Hwaseong Si, Korea, Republic of
        • Hallym University Dongtan Sacred Heart Hospital
      • Jeollabuk-do, Korea, Republic of, 54907
        • Chonbuk National University Hospital
      • Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Jeonlabuk-do, Korea, Republic of, 54538
        • Wonkwang University School of Medicine & Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Centre; Division of Hematology/Oncology
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University
      • Seoul, Korea, Republic of, 01812
        • Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 06591
        • Seoul St Mary's Hospital
      • Seoul, Korea, Republic of, 07061
        • Borame Medical Center
      • Seoul, Korea, Republic of, 06973
        • Chungang University Hospital
      • Seoul, Korea, Republic of, 04763
        • Hanyang University Medical Center
      • Seoul, Korea, Republic of, 05368
        • VHS Medical Center
      • Seoul, Korea, Republic of, 03312
        • Eunpyeong St. Mary's Hoapital
      • Seoul, Korea, Republic of, 04401
        • Soonchunhyang University Hospital
      • Seoul, Korea, Republic of, 05278
        • Gangdong Kyung Hee University Hospital
      • Seoul, Korea, Republic of, 07345
        • Yeouido St. Mary's Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System; Oncology
      • Seoul, Korea, Republic of
        • Ewha Womans University Mokdong Hospital; Urology
      • Seoul, Korea, Republic of
        • Korea Uni Anam Hospital; Internal Medicine
      • Seoul, Korea, Republic of
        • Soonchunhyang University Hospital Seoul
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hosiptal
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital
      • Wonju-Si, Korea, Republic of, 220-701
        • Yonsei University Wonju Severance Christian Hospital
      • Yangsan, Korea, Republic of
        • Pusan National University Yangsan Hospital; hemato-oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who are administered with atezolizumab at physician's discretion will be enrolled for the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Atezolizumab
Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.
Other Names:
  • Tecentriq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame: Approximately 6 years
Approximately 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time Frame: Approximately 6 years
Approximately 6 years
Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1
Time Frame: Approximately 6 years
Approximately 6 years
Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1
Time Frame: Approximately 6 years
Approximately 6 years
Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1
Time Frame: Approximately 6 years
Approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2017

Primary Completion (Actual)

August 12, 2022

Study Completion (Actual)

August 12, 2022

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML39313

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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