A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

Conditions
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Urinary Tract Cancer

Intervention / Treatment
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* Drug: Atezolizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Participants with measurable and/or non-measurable disease according to RECIST v1.1 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 If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block should be submitted Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2 Exclusion Criteria: 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 Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation 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 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 Malignancies other than the one studied in this protocol within 5 years prior to Cycle 1, Day 1 Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol Significant renal disorder indicating a need for renal transplant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atezolizumab<br>Participants will receive atezolizumab every 3 weeks (Q3W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). | Drug: Atezolizumab<br>* Atezolizumab 1200 milligrams (mg) will be administered by intravenous (IV) infusion Q3W.<br>* Other names: MPDL3280A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events |  | Baseline up to end of study (up to approximately 6 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Randomization until death from any cause (up to approximately 6 years) | 
| Progression Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |  | Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) | 
| PFS as per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) |  | Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) | 
| Percentage of Participants With Best Overall Response as Assessed by RECIST v1.1 |  | Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) | 
| Percentage of Participants With Best Overall Response as Assessed by Modified RECIST |  | Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) | 
| Percentage of Participants With Disease Control as Assessed by RECIST v1.1 |  | Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) | 
| Percentage of Participants With Disease Control as Assessed by Modified RECIST |  | Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) | 
| Duration of Response as Assessed by RECIST v1.1 |  | Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) | 
| Duration of Response as Assessed by Modified RECIST |  | Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) | 
| 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 |  | Baseline, Day 1 of Cycles 1, 2, 3 and thereafter every 9 weeks for 54 weeks from study treatment start; and then every 12 weeks until progression/study discontinuation (up to approximately 6 years) (Cycle length = 21 days) | 
| Change from Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score |  | Baseline, Day 1 of Cycles 1, 2, 3 and thereafter every 9 weeks for 54 weeks from study treatment start; and then every 12 weeks until progression/study discontinuation (up to approximately 6 years) (Cycle length = 21 days) |