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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02928406
Ethics application status
Date submitted
7/10/2016
Date registered
10/10/2016
Date last updated
4/04/2024

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 (AEs)
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 occurred 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 occurred first (up to approximately 6 years)
Secondary outcome [4] 0 0
Percentage of Participants With Best Overall Response (BOR) as Assessed by RECIST v1.1
Timepoint [4] 0 0
Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Secondary outcome [5] 0 0
Percentage of Participants With BOR as Assessed by Modified RECIST
Timepoint [5] 0 0
Randomization up to disease progression or death from any cause, whichever occurred 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 occurred 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 occurred first (up to approximately 6 years)
Secondary outcome [8] 0 0
Duration of Response (DOR) 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 occurred first (up to approximately 6 years)
Secondary outcome [9] 0 0
DOR 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 occurred 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
Sex
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
Not applicable
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/12/2022
Sample size
Target
Accrual to date
Final
1004
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
Country [12] 0 0
Brazil
State/province [12] 0 0
CE
Country [13] 0 0
Brazil
State/province [13] 0 0
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
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
Nova Scotia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
China
State/province [21] 0 0
Nanjing City
Country [22] 0 0
Colombia
State/province [22] 0 0
Bogota
Country [23] 0 0
Croatia
State/province [23] 0 0
Zagreb
Country [24] 0 0
Czechia
State/province [24] 0 0
Brno
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha
Country [26] 0 0
Denmark
State/province [26] 0 0
Aalborg
Country [27] 0 0
Denmark
State/province [27] 0 0
Aarhus N
Country [28] 0 0
Denmark
State/province [28] 0 0
Herlev
Country [29] 0 0
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
Country [33] 0 0
Germany
State/province [33] 0 0
Göttingen
Country [34] 0 0
Germany
State/province [34] 0 0
Halle (Saale)
Country [35] 0 0
Germany
State/province [35] 0 0
Hannover
Country [36] 0 0
Germany
State/province [36] 0 0
Heidelberg
Country [37] 0 0
Germany
State/province [37] 0 0
Lübeck
Country [38] 0 0
Germany
State/province [38] 0 0
Mönchengladbach
Country [39] 0 0
Germany
State/province [39] 0 0
München
Country [40] 0 0
Germany
State/province [40] 0 0
Münster
Country [41] 0 0
Germany
State/province [41] 0 0
Tübingen
Country [42] 0 0
Germany
State/province [42] 0 0
Ulm
Country [43] 0 0
Greece
State/province [43] 0 0
Athens
Country [44] 0 0
Greece
State/province [44] 0 0
Kifisia
Country [45] 0 0
Greece
State/province [45] 0 0
Piraeus
Country [46] 0 0
Greece
State/province [46] 0 0
Thermi Thessalonikis
Country [47] 0 0
Greece
State/province [47] 0 0
Thessaloniki
Country [48] 0 0
Hungary
State/province [48] 0 0
Budapest
Country [49] 0 0
Hungary
State/province [49] 0 0
Szeged
Country [50] 0 0
Hungary
State/province [50] 0 0
Szolnok
Country [51] 0 0
India
State/province [51] 0 0
Delhi
Country [52] 0 0
India
State/province [52] 0 0
Gujarat
Country [53] 0 0
India
State/province [53] 0 0
Haryana
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India
State/province [54] 0 0
WEST Bengal
Country [55] 0 0
Ireland
State/province [55] 0 0
Cork
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Ireland
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Dublin
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Italy
State/province [57] 0 0
Abruzzo
Country [58] 0 0
Italy
State/province [58] 0 0
Campania
Country [59] 0 0
Italy
State/province [59] 0 0
Emilia-Romagna
Country [60] 0 0
Italy
State/province [60] 0 0
Friuli-Venezia Giulia
Country [61] 0 0
Italy
State/province [61] 0 0
Lazio
Country [62] 0 0
Italy
State/province [62] 0 0
Liguria
Country [63] 0 0
Italy
State/province [63] 0 0
Lombardia
Country [64] 0 0
Italy
State/province [64] 0 0
Piemonte
Country [65] 0 0
Italy
State/province [65] 0 0
Puglia
Country [66] 0 0
Italy
State/province [66] 0 0
Sardegna
Country [67] 0 0
Italy
State/province [67] 0 0
Sicilia
Country [68] 0 0
Italy
State/province [68] 0 0
Toscana
Country [69] 0 0
Italy
State/province [69] 0 0
Umbria
Country [70] 0 0
Italy
State/province [70] 0 0
Veneto
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Lebanon
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Beirut
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Lithuania
State/province [72] 0 0
Kaunas
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Lithuania
State/province [73] 0 0
Vilnius
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Netherlands
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Amsterdam
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Netherlands
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Groningen
Country [76] 0 0
Netherlands
State/province [76] 0 0
Maastricht
Country [77] 0 0
Netherlands
State/province [77] 0 0
Utrecht
Country [78] 0 0
Poland
State/province [78] 0 0
?ory
Country [79] 0 0
Poland
State/province [79] 0 0
Lublin
Country [80] 0 0
Poland
State/province [80] 0 0
Poznan
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Poland
State/province [81] 0 0
Warszawa
Country [82] 0 0
Portugal
State/province [82] 0 0
Braga
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Portugal
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Coimbra
Country [84] 0 0
Portugal
State/province [84] 0 0
Lisboa
Country [85] 0 0
Portugal
State/province [85] 0 0
Porto
Country [86] 0 0
Romania
State/province [86] 0 0
Baia Mare
Country [87] 0 0
Romania
State/province [87] 0 0
Cluj-Napoca
Country [88] 0 0
Romania
State/province [88] 0 0
Craiova
Country [89] 0 0
Romania
State/province [89] 0 0
Floresti
Country [90] 0 0
Romania
State/province [90] 0 0
Timisoara
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Moskovskaja Oblast
Country [92] 0 0
Saudi Arabia
State/province [92] 0 0
Riyadh
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Slovakia
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Bratislava
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Asturias
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Barcelona
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Cordoba
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Islas Baleares
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LA Coruña
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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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Spain
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Malaga
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Spain
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Murcia
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Spain
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Navarra
Country [109] 0 0
Spain
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Orense
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Spain
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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
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Basel
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Switzerland
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Bellinzona
Country [115] 0 0
Switzerland
State/province [115] 0 0
Bern
Country [116] 0 0
Switzerland
State/province [116] 0 0
Chur
Country [117] 0 0
Switzerland
State/province [117] 0 0
Geneve
Country [118] 0 0
Switzerland
State/province [118] 0 0
Luzern
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Switzerland
State/province [119] 0 0
Winterthur
Country [120] 0 0
Taiwan
State/province [120] 0 0
Tainan
Country [121] 0 0
Taiwan
State/province [121] 0 0
Taoyuan
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Cardiff
Country [123] 0 0
United Kingdom
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Inverness
Country [124] 0 0
United Kingdom
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Leicester
Country [125] 0 0
United Kingdom
State/province [125] 0 0
London
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Sutton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02928406