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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
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Brazil
State/province [12] 0 0
CE
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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
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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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Canada
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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
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Croatia
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Zagreb
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Czechia
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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
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Herlev
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Denmark
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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
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Kifisia
Country [45] 0 0
Greece
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Piraeus
Country [46] 0 0
Greece
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Thermi Thessalonikis
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Greece
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Thessaloniki
Country [48] 0 0
Hungary
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Budapest
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Hungary
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Szeged
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Hungary
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Szolnok
Country [51] 0 0
India
State/province [51] 0 0
Delhi
Country [52] 0 0
India
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Gujarat
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India
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Haryana
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India
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WEST Bengal
Country [55] 0 0
Ireland
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Cork
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Dublin
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Abruzzo
Country [58] 0 0
Italy
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Campania
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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
Country [71] 0 0
Lebanon
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Beirut
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State/province [72] 0 0
Kaunas
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Lithuania
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Vilnius
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Amsterdam
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Groningen
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Maastricht
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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
Country [81] 0 0
Poland
State/province [81] 0 0
Warszawa
Country [82] 0 0
Portugal
State/province [82] 0 0
Braga
Country [83] 0 0
Portugal
State/province [83] 0 0
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
State/province [93] 0 0
Bratislava
Country [94] 0 0
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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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Spain
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LA Coruña
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Spain
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Tenerife
Country [100] 0 0
Spain
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Vizcaya
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Spain
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Caceres
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Spain
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Girona
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Spain
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Guadalajara
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Malaga
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Spain
State/province [107] 0 0
Murcia
Country [108] 0 0
Spain
State/province [108] 0 0
Navarra
Country [109] 0 0
Spain
State/province [109] 0 0
Orense
Country [110] 0 0
Spain
State/province [110] 0 0
Sevilla
Country [111] 0 0
Spain
State/province [111] 0 0
Toledo
Country [112] 0 0
Spain
State/province [112] 0 0
Valencia
Country [113] 0 0
Switzerland
State/province [113] 0 0
Basel
Country [114] 0 0
Switzerland
State/province [114] 0 0
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
Country [119] 0 0
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
State/province [123] 0 0
Inverness
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Leicester
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State/province [125] 0 0
London
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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
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/study/NCT02928406
Trial related presentations / publications
Bamias 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.
Merseburger 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.
Loriot 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.
Cathomas 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.
Sternberg CN, Loriot Y, James N, Choy E, Castellano D, Lopez-Rios F, Banna GL, De Giorgi U, Masini C, Bamias A, Garcia Del Muro X, Duran I, Powles T, Gamulin M, Zengerling F, Geczi L, Gedye C, de Ducla S, Fear S, Merseburger AS. Primary Results from SAUL, a Multinational Single-arm Safety Study of Atezolizumab Therapy for Locally Advanced or Metastatic Urothelial or Nonurothelial Carcinoma of the Urinary Tract. Eur Urol. 2019 Jul;76(1):73-81. doi: 10.1016/j.eururo.2019.03.015. Epub 2019 Mar 23.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02928406