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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02928406




Registration number
NCT02928406
Ethics application status
Date submitted
7/10/2016
Date registered
10/10/2016
Date last updated
9/04/2021

Titles & IDs
Public title
A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
Scientific title
An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
Secondary ID [1] 0 0
2016-002625-11
Secondary ID [2] 0 0
MO29983
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Tract Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab

Experimental: 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).


Treatment: Drugs: Atezolizumab
Atezolizumab 1200 milligrams (mg) will be administered by intravenous (IV) infusion Q3W.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events
Timepoint [1] 0 0
Baseline up to end of study (up to approximately 6 years)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization until death from any cause (up to approximately 6 years)
Secondary outcome [2] 0 0
Progression Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Timepoint [2] 0 0
Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [3] 0 0
PFS as per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST)
Timepoint [3] 0 0
Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [4] 0 0
Percentage of Participants With Best Overall Response as Assessed by RECIST v1.1
Timepoint [4] 0 0
Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [5] 0 0
Percentage of Participants With Best Overall Response as Assessed by Modified RECIST
Timepoint [5] 0 0
Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [6] 0 0
Percentage of Participants With Disease Control as Assessed by RECIST v1.1
Timepoint [6] 0 0
Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [7] 0 0
Percentage of Participants With Disease Control as Assessed by Modified RECIST
Timepoint [7] 0 0
Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [8] 0 0
Duration of Response as Assessed by RECIST v1.1
Timepoint [8] 0 0
Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [9] 0 0
Duration of Response as Assessed by Modified RECIST
Timepoint [9] 0 0
Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
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)
Secondary outcome [11] 0 0
Change from Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score
Timepoint [11] 0 0
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)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Canberra Hospital; Medical Oncology - Canberra
Recruitment hospital [2] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [3] 0 0
Prince of Wales Hospital; Oncology - Randwick
Recruitment hospital [4] 0 0
Northern Cancer Institute - St Leonards
Recruitment hospital [5] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [6] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Royal Hobart Hospital; Hematology/Oncology - Hobart
Recruitment hospital [9] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [10] 0 0
Austin Hospital Olivia Newton John Cancer Centre - Heidelberg
Recruitment postcode(s) [1] 0 0
2606 - Canberra
Recruitment postcode(s) [2] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
7000 - Hobart
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Caba
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad Autonoma Buenos Aires
Country [4] 0 0
Austria
State/province [4] 0 0
Innsbruck
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
Austria
State/province [6] 0 0
Salzburg
Country [7] 0 0
Austria
State/province [7] 0 0
Wien
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussel
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Belgium
State/province [11] 0 0
Liège
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Brazil
State/province [12] 0 0
CE
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Brazil
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PR
Country [14] 0 0
Brazil
State/province [14] 0 0
RS
Country [15] 0 0
Brazil
State/province [15] 0 0
SP
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Plovdiv
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sofia
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Canada
State/province [18] 0 0
Alberta
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Canada
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Nova Scotia
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Ontario
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China
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Nanjing City
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Colombia
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Bogota
Country [23] 0 0
Croatia
State/province [23] 0 0
Zagreb
Country [24] 0 0
Czechia
State/province [24] 0 0
Brno
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Czechia
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Praha
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Denmark
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Aalborg
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Denmark
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Aarhus N
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Denmark
State/province [28] 0 0
Herlev
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Denmark
State/province [29] 0 0
København Ø
Country [30] 0 0
Estonia
State/province [30] 0 0
Tallinn
Country [31] 0 0
Germany
State/province [31] 0 0
Dresden
Country [32] 0 0
Germany
State/province [32] 0 0
Erlangen
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Germany
State/province [33] 0 0
Göttingen
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Germany
State/province [34] 0 0
Halle (Saale)
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Germany
State/province [35] 0 0
Hannover
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Germany
State/province [36] 0 0
Heidelberg
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Germany
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Lübeck
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Germany
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Mönchengladbach
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Germany
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München
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Germany
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Münster
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Germany
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Tübingen
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Ulm
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Kifisia
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Piraeus
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Thermi Thessalonikis
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Thessaloniki
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Hungary
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Budapest
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Szeged
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Hungary
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Szolnok
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India
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Gujarat
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India
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WEST Bengal
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India
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Gurgaon
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Cork
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Campania
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Emilia-Romagna
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Friuli-Venezia Giulia
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Lazio
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Liguria
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Lombardia
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Piemonte
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Puglia
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Toscana
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Tenerife
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Vizcaya
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Caceres
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Girona
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Guadalajara
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Lugo
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Madrid
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Malaga
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Murcia
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Navarra
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Orense
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Sevilla
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Spain
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Toledo
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Spain
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Valencia
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Switzerland
State/province [113] 0 0
Basel
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Switzerland
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Bellinzona
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Switzerland
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Bern
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Switzerland
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Chur
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Switzerland
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Geneve
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Luzern
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Winterthur
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Taiwan
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Tainan
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Taiwan
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Taoyuan
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Cardiff
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Inverness
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London
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02928406
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications