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

Hoffmann-La Roche175 sites in 14 countries1,004 target enrollmentNovember 30, 2016

ConditionsUrinary Tract Cancer

InterventionsAtezolizumab

DrugsAtezolizumab

Overview

Phase: Phase 3
Intervention: Atezolizumab
Conditions: Urinary Tract Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 1004
Locations: 175
Primary Endpoint: Percentage of Participants With Adverse Events (AEs)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 30, 2016

End Date

December 12, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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

Arms & Interventions

Atezolizumab

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).

Intervention: Atezolizumab

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events (AEs)

Time Frame: Baseline up to end of study (up to approximately 6 years)

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.

Secondary Outcomes

Percentage of Participants With Disease Control as Assessed by RECIST v1.1(Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years))
Percentage of Participants With Best Overall Response (BOR) as Assessed by RECIST v1.1(Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years))
Percentage of Participants With BOR as Assessed by Modified RECIST(Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years))
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 occurred 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 occurred 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 occurred first (up to approximately 6 years))
Duration of Response (DOR) as Assessed by RECIST v1.1(Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years))
DOR as Assessed by Modified RECIST(Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred 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))