Clinical trial · Interventional
A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
NCT02928406CI-TRIAL-00075718completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Tract Cancer | Malignant Urinary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Atezolizumab
- description
- 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).
- interventionNames
- Drug: Atezolizumab
Primary outcomes (1)
- measure
- Percentage of Participants With Adverse Events (AEs)
- timeFrame
- Baseline up to end of study (up to approximately 6 years)
- description
- AEs were defined as any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. New disease, exacerbation of existing disease, recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test associated with symptoms or leading to a change in study/concomitant treatment or discontinuation from study drug as well as events related to protocol-mandated interventions are considered AEs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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 * 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
References
Publications (6)
- DERIVEDBamias A, Merseburger A, Loriot Y, James N, Choy E, Castellano D, Lopez-Rios F, Calabro F, Kramer M, de Velasco G, Zakopoulou R, Tzannis K, Sternberg CN. New prognostic model in patients with advanced urothelial carcinoma treated with second-line immune checkpoint inhibitors. J Immunother Cancer. 2023 Jan;11(1):e005977. doi: 10.1136/jitc-2022-005977. PMID 36627145
- DERIVEDBamias A, Merseburger AS, Loriot Y, James N, Choy E, Castellano D, Lopez-Rios F, Calabro F, Kramer M, de Velasco G, Zakopoulou R, Tzannis K, Sternberg CN. 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. ESMO Open. 2021 Jun;6(3):100152. doi: 10.1016/j.esmoop.2021.100152. Epub 2021 May 10. PMID 33984672
- DERIVEDMerseburger AS, Castellano D, Powles T, Loriot Y, Retz M, Voortman J, Huddart RA, Gedye C, Van Der Heijden MS, Gurney H, Ong M, de Ducla S, Pavlova J, Fear S, Sternberg CN. Safety and Efficacy of Atezolizumab in Understudied Populations with Pretreated Urinary Tract Carcinoma: Subgroup Analyses of the SAUL Study in Real-World Practice. J Urol. 2021 Aug;206(2):240-251. doi: 10.1097/JU.0000000000001768. Epub 2021 Apr 9. PMID 33835866
- DERIVEDLoriot Y, Sternberg CN, Castellano D, Oosting SF, Dumez H, Huddart R, Vianna K, Alonso Gordoa T, Skoneczna I, Fay AP, Nole F, Massari F, Brasiuniene B, Maroto P, Fear S, Di Nucci F, de Ducla S, Choy E. Safety and efficacy of atezolizumab in patients with autoimmune disease: Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma. Eur J Cancer. 2020 Oct;138:202-211. doi: 10.1016/j.ejca.2020.07.023. Epub 2020 Sep 6. PMID 32905959
- DERIVEDCathomas R, Schardt J, Pless M, Llado A, Mach N, Riklin C, Haefeli J, Fear S, Stenner F. Swiss experience of atezolizumab for platinum-pretreated urinary tract carcinoma: the SAUL study in real-world practice. Swiss Med Wkly. 2020 May 4;150:w20223. doi: 10.4414/smw.2020.20223. eCollection 2020 May 4.