Urothelial CarcinomaNCT03232593
A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)
An observational study of Urothelial Carcinoma and Carcinoma, Non-Small Cell Lung, run by Hoffmann-La Roche at 56 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urothelial Carcinoma, Carcinoma, Non-Small Cell Lung, Small Cell Lung Carcinoma
- What is being tested?
- Atezolizumab
- How many people
- 1,758 participants
- Where
- 56 sitesSouth Korea
- Study dates
- 29 Nov 2017to 12 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who are administered with atezolizumab at physician's discretion will be enrolled for the study.
Who may be able to join
- Participants who are administered with atezolizumab for the locally approved indications
Who cannot join
- Participants with a known hypersensitivity to atezolizumab or to any of the excipients
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
South Korea56 sites
Dongnam Inst.of Radiological & Medical Sciences
Busan, 46033
Inje University Busan Paik Hospital
Busan, 47392
Inje university Haeundae Paik Hospital
Busan, 48108
Dong-A University Hospital
Busan, 49201
Pusan National University Hospital
Busan, 49241
Kosin University Gospel Hospital
Busan, 49267
Donga Uni Medical Center; Pulmonary
Busan, 602-715
Pusan University Hospital
Busan, 602-739
Pusan University Hospital; Hemato-oncology
Busan
Kyungpook National University Medical Center
Daegu, 41404
Keimyung University Dongsan Medical Center
Daegu, 41931
Daegu Catholic University Medical Center
Daegu, 42472
Keimyung University Dongsan Hospital; Pulmonology
Daegu, 42601
Konyang University Hospital
Daejeon, 35365
Hallym University Medical Center Chuncheon Sacred Heart Hospital
Gangwon-do, 24253
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, 26426
Gangneung Asan Hospital
Gangwon-do
Uijeongbu St. Mary's Hospital
Gyeonggi-do, 11765
CHA Bundang Medical Center
Gyeonggi-do, 13496
Hallym University Sacred Heart Hospital
Gyeonggi-do, 14068
Soonchunhyang University Bucheon Hospital
Gyeonggi-do, 14584
Bucheon St Mary's hospital
Gyeonggi-do, 14647
Korea University Ansan Hospital
Gyeonggi-do, 15355
St. Vincent's Hospital
Gyeonggi-do, 16247
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si
Chonbuk National University Hospital
Jeollabuk-do, 54907
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Wonkwang University School of Medicine & Hospital
Jeonlabuk-do, 54538
Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
Seoul, 01812
Korea University Anam Hospital
Seoul, 02841
Kangbuk Samsung Hospital
Seoul, 03181
Eunpyeong St. Mary's Hoapital
Seoul, 03312
Severance Hospital, Yonsei University Health System
Seoul, 03722
Severance Hospital, Yonsei University
Seoul, 03722
Soonchunhyang University Hospital
Seoul, 04401
Hanyang University Medical Center
Seoul, 04763
Gangdong Kyung Hee University Hospital
Seoul, 05278
VHS Medical Center
Seoul, 05368
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital
Seoul, 06273
Samsung Medical Center
Seoul, 06351
Seoul St Mary's Hospital
Seoul, 06591
ChungAng University Hospital
Seoul, 06973
Borame Medical Center
Seoul, 07061
Yeouido St. Mary's Hospital
Seoul, 07345
Korea University Guro Hospital
Seoul, 08308
Severance Hospital, Yonsei University Health System; Oncology
Seoul, 120-752
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, 135-710
Ewha Womans University Mokdong Hospital; Urology
Seoul
Korea Uni Anam Hospital; Internal Medicine
Seoul
SoonChunHyang University Hospital Seoul
Seoul
Ulsan University Hosiptal
Ulsan, 44033
Ulsan University Hospital
Ulsan, 44033
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220-701
Pusan National University Yangsan Hospital; hemato-oncology
Yangsan
About this study
Official title: 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.
- Conditions
- Urothelial Carcinoma, Carcinoma, Non-Small Cell Lung, Small Cell Lung Carcinoma, Triple Negative Breast Carcinoma, Hepatocellular Carcinoma
- Being tested
- Atezolizumab
- Medical subject headings
- Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Triple Negative Breast Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called Tecentriq
Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Measured: 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)
Measured: Approximately 6 years
Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1
Measured: Approximately 6 years
Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1
Measured: Approximately 6 years
Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1
Measured: Approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start29 Nov 2017
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,758 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232593
- Sponsor's protocol ID
- ML39313
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2017
- Last updated
- 24 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)
- ClinicalTrials.gov ID
- NCT03232593
- Acronym / sponsor ID
- ML39313
- Conditions
- Urothelial Carcinoma, Carcinoma, Non-Small Cell Lung, Small Cell Lung Carcinoma, Triple Negative Breast Carcinoma, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,758 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants who Receive Atezolizumab | – | Drug: AtezolizumabParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who are administered with atezolizumab at physician's discretion will be enrolled for the study.
Key inclusion criteria (1 listed)
- Participants who are administered with atezolizumab for the locally approved indications
Key exclusion criteria (1 listed)
- Participants with a known hypersensitivity to atezolizumab or to any of the excipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: TecentriqParticipants will receive atezolizumab as per the local label and standard of care at physician's discretion. | Drug | Participants who Receive Atezolizumab |
Primary outcome
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Approximately 6 years
4 secondary outcomes
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
Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1
Time frame: Approximately 6 years
Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1
Time frame: Approximately 6 years
Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1
Time frame: Approximately 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma and Carcinoma, Non-Small Cell Lung, run by Hoffmann-La Roche at 56 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (time frame: Approximately 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.