Phase 3
Completed N=1,004
A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
Urinary Tract Cancer
Source: ClinicalTrials.gov NCT02928406 ↗
Enrolled (actual)
1,004
Serious AEs
38.1%
Results posted
Apr 2024
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) — 900 Participants
◆ Published Evidence
Established
58citations · ~10 / year
Safety and efficacy of atezolizumab in patients with autoimmune disease: Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma.
Summary
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.
Linked Publications (5)
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Safety and efficacy of atezolizumab in patients with autoimmune disease: Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma.
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New prognostic model in patients with advanced urothelial carcinoma treated with second-line immune checkpoint inhibitors.
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Safety and Efficacy of Atezolizumab in Understudied Populations with Pretreated Urinary Tract Carcinoma: Subgroup Analyses of the SAUL Study in Real-World Practice.
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SAUL, a single-arm study of atezolizumab for chemotherapy-pretreated locally advanced or metastatic carcinoma of the urinary tract: outcomes by key baseline factors, PD-L1 expression and prior platinum therapy.
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Swiss experience of atezolizumab for platinum-pretreated urinary tract carcinoma: the SAUL study in real-world practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
900 | — |
| SECONDARY Overall Survival (OS) |
8.57 | — |
| SECONDARY Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
2.20 | — |
| SECONDARY PFS as Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) |
2.79 | — |
| SECONDARY Percentage of Participants With Best Overall Response (BOR) as Assessed by RECIST v1.1 |
15.7 | — |
| SECONDARY Percentage of Participants With BOR as Assessed by Modified RECIST |
16.4 | — |
| SECONDARY Percentage of Participants With Disease Control as Assessed by RECIST v1.1 |
39.9 | — |
| SECONDARY Percentage of Participants With Disease Control as Assessed by Modified RECIST |
46.0 | — |
| SECONDARY Duration of Response (DOR) as Assessed by RECIST v1.1 |
27.79 | — |
| SECONDARY DOR as Assessed by Modified RECIST |
29.73 | — |
| SECONDARY 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 |
70.62; -3.43; -3.98; -2.01; 1.72; 3.10 | — |
| SECONDARY Change From Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score |
1.9; 0.1; 0.2; 0.1; 0.0; -0.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02928406) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.