Clinical Trials List
Protocol NumberMO29983
NCT Number(ClinicalTrials.gov Identfier)NCT02928406
Completed
2017-07-15 - 2022-06-30
Phase III
Terminated2
ICD-10C67
Malignant neoplasm of bladder
An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract.
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Trial Applicant
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Sponsor
Hoffmann-La Roche
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Linkou Chang Gung Medical Foundation
Taiwan National PI
莊正鏗
Co-Principal Investigator
- Po-Jung Su Division of Hematology & Oncology
- See-Tong Pang Division of Hematology & Oncology
- Yung-Chia Kao Division of Hematology & Oncology
- 劉忠一 Division of Hematology & Oncology
- 張英勛 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
2 Terminated
Audit
None
Co-Principal Investigator
- Ya-Ting Hsu Division of General Internal Medicine
- Jui-Hung Tsai Division of General Internal Medicine
- Shang-Yin Wu Division of General Internal Medicine
- Wu-Chou Su Division of General Internal Medicine
- 劉奕廷 Division of General Internal Medicine
- Wei-Pang Chung Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Urinary Tract Cancer
Objectives
This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab.
Test Drug
TECENTRIQ (Atezolizumab)
Active Ingredient
Atezolizumab
Dosage Form
Injection
Dosage
1200mg/20ml
Endpoints
Primary Outcome Measures:
1. Percentage of Participants With Adverse Events.
Secondary Outcome Measures:
1. Overall Survival (OS).
2. Progression Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
3. PFS as per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST).
4. Percentage of Participants With Best Overall Response as Assessed by RECIST v1.1.
5. Percentage of Participants With Best Overall Response as Assessed by Modified RECIST.
6. Percentage of Participants With Disease Control as Assessed by RECIST v1.1.
7. Percentage of Participants With Disease Control as Assessed by Modified RECIST.
8. Duration of Response as Assessed by RECIST v1.1.
9. Duration of Response as Assessed by Modified RECIST.
10. Change From Baseline in Health-Related Quality of Life (HRQoL), as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score.
11. Change from Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score.
1. Percentage of Participants With Adverse Events.
Secondary Outcome Measures:
1. Overall Survival (OS).
2. Progression Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
3. PFS as per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST).
4. Percentage of Participants With Best Overall Response as Assessed by RECIST v1.1.
5. Percentage of Participants With Best Overall Response as Assessed by Modified RECIST.
6. Percentage of Participants With Disease Control as Assessed by RECIST v1.1.
7. Percentage of Participants With Disease Control as Assessed by Modified RECIST.
8. Duration of Response as Assessed by RECIST v1.1.
9. Duration of Response as Assessed by Modified RECIST.
10. Change From Baseline in Health-Related Quality of Life (HRQoL), as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score.
11. Change from Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score.
Inclution Criteria
1. Participants with histologically documented locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial carcinoma of the urinary tract
2. Participants with measurable and/or non-measurable disease according to RECIST v1.1
3. Participants must have progressed during or following treatment with at least one prior (and not more than 3) treatments for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
4. If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block should be submitted
5. Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2
2. Participants with measurable and/or non-measurable disease according to RECIST v1.1
3. Participants must have progressed during or following treatment with at least one prior (and not more than 3) treatments for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
4. If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block should be submitted
5. Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2
Exclusion Criteria
1. Treatment with more than three prior lines of systemic therapy for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation
(1) Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were not on active drug in that prior trial are eligible
(2) Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were in the follow-up phase of that prior trial and had stopped receiving active drug 4 or more weeks before study treatment initiation are eligible
3. Malignancies other than the one studied in this protocol within 5 years prior to Cycle 1, Day 1
4. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
5. Significant renal disorder indicating a need for renal transplant
2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation
(1) Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were not on active drug in that prior trial are eligible
(2) Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were in the follow-up phase of that prior trial and had stopped receiving active drug 4 or more weeks before study treatment initiation are eligible
3. Malignancies other than the one studied in this protocol within 5 years prior to Cycle 1, Day 1
4. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
5. Significant renal disorder indicating a need for renal transplant
The Estimated Number of Participants
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Taiwan
8 participants
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Global
1000 participants
