Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
0
0
2016-002625-11
Query!
Secondary ID [2]
0
0
MO29983
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Urinary Tract Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Kidney
Query!
Cancer
0
0
0
0
Query!
Bladder
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Adverse Events (AEs)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline up to end of study (up to approximately 6 years)
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS was defined as date of death (due to any cause) or censoring minus date of start of study treatment plus 1.
Query!
Timepoint [1]
0
0
Randomization until death from any cause (up to approximately 6 years)
Query!
Secondary outcome [2]
0
0
Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Query!
Assessment method [2]
0
0
PFS was defined as the date of first occurrence of tumor progression (earliest of the dates of the RECIST component indicating tumor progression) or date of death (in the absence of tumor progression) by any cause, whichever occurred first, or date of censoring minus date of start of study treatment plus 1.
Query!
Timepoint [2]
0
0
Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Query!
Secondary outcome [3]
0
0
PFS as Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST)
Query!
Assessment method [3]
0
0
PFS as per Modified RECIST was defined as:
* date of first occurrence of tumor progression after a modified confirmed response if the participant was a responder according to modified RECIST or
* date of first occurrence of tumor progression in case the participant was not a responder according to modified RECIST or
* date of death (in the absence of tumor progression) by any cause, or
* date of censoring whichever occurred first, minus date of start of study treatment plus 1
Query!
Timepoint [3]
0
0
Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Best Overall Response (BOR) as Assessed by RECIST v1.1
Query!
Assessment method [4]
0
0
BOR was assessed by the investigators according to the RECIST v1.1. BOR was defined as a complete response (CR) or partial response (PR) determined on two consecutive investigator assessments \>= 4 weeks apart in participants with measurable disease at baseline. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 millimeters (mm); PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must have demonstrated an absolute increase of at least 5 mm. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Query!
Timepoint [4]
0
0
Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Query!
Secondary outcome [5]
0
0
Percentage of Participants With BOR as Assessed by Modified RECIST
Query!
Assessment method [5]
0
0
BOR was assessed by the investigators according to the modified RECIST. BOR was defined as complete response (CR) or partial response (PR). CR includes complete disappearance of all tumor lesions and no new measurable or unmeasurable lesions confirmed by a consecutive assessment \>=4 weeks from the first documented date. PR is a decrease in the sum of the diameters of all target and all new measurable lesions \>=30%, relative to baseline, in the absence of CR confirmed by a consecutive assessment \>=4 weeks from the first documented date. The assessment of BOR included post-screening RECIST assessments obtained up to: 1) death from any cause, 2) last evaluable RECIST assessment in the absence of death, 3) start of a subsequent anti-cancer therapy, whichever occurred first.
Query!
Timepoint [5]
0
0
Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Query!
Secondary outcome [6]
0
0
Percentage of Participants With Disease Control as Assessed by RECIST v1.1
Query!
Assessment method [6]
0
0
Disease control was determined separately on disease status using RECIST v1.1 by the investigator. Disease control rate was defined as the sum of the complete response, partial response, and stable disease rates.
Query!
Timepoint [6]
0
0
Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Query!
Secondary outcome [7]
0
0
Percentage of Participants With Disease Control as Assessed by Modified RECIST
Query!
Assessment method [7]
0
0
Disease control was determined separately on disease status using modified RECIST by the investigator. Disease control rate was defined as the sum of the complete response, partial response, and stable disease rates.
Query!
Timepoint [7]
0
0
Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Query!
Secondary outcome [8]
0
0
Duration of Response (DOR) as Assessed by RECIST v1.1
Query!
Assessment method [8]
0
0
Duration of response was determined separately on disease status using RECIST v1.1 by the investigator. For overall responders, DoR was defined as the time from the date of first occurrence of a confirmed response (complete response or partial response) to date of tumor progression or death from any cause, or to censoring date: 1) end of response coincided with the date of tumor progression or death (in the absence of tumor progression) used for the PFS endpoint, 2) for a participant without disease progression or death following a response, the censored end of response coincided with the PFS censoring date (that was latest RECIST assessment or start of subsequent cancer therapy, whichever occurred first).
Query!
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)
Query!
Secondary outcome [9]
0
0
DOR as Assessed by Modified RECIST
Query!
Assessment method [9]
0
0
Duration of response was determined separately on disease status using modified RECIST by the investigator. For overall responders, DoR was defined as the time from the date of first occurrence of a confirmed response (complete response or partial response) to date of tumor progression following that confirmed response or death from any cause, or to censoring date: 1) end of response was the date of tumor progression after that confirmed response or death (in the absence of tumor progression), 2) for a participant without disease progression or death following a response, the censored end of response was the latest RECIST assessment or start of subsequent cancer therapy, whichever occurred first.
Query!
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)
Query!
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
Query!
Assessment method [10]
0
0
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to 0 - 100 scale. Higher scores on the global health status and functional scales indicated better health status/function. Higher scores on the symptoms scales and symptom items indicated greater symptom burden.
Query!
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)
Query!
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
Query!
Assessment method [11]
0
0
The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) is a self-report health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are two components to the EuroQol EQ-5D: 1) five health dimensions that assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; 2) a visual analogue scale (VAS) that measures health state. There are 5 response levels for each dimension (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems) with the highest level representing the worst outcome. The VAS is scored on a scale from 0 to 100, with 0 representing the worst imaginable health and 100 representing the best imaginable health.
Query!
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)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/11/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
12/12/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1004
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Canberra Hospital; Medical Oncology - Canberra
Query!
Recruitment hospital [2]
0
0
Macquarie University Hospital - Macquarie Park
Query!
Recruitment hospital [3]
0
0
Prince of Wales Hospital; Oncology - Randwick
Query!
Recruitment hospital [4]
0
0
Northern Cancer Institute - St Leonards
Query!
Recruitment hospital [5]
0
0
Calvary Mater Newcastle; Medical Oncology - Waratah
Query!
Recruitment hospital [6]
0
0
Icon Cancer Foundation - South Brisbane
Query!
Recruitment hospital [7]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [8]
0
0
Royal Hobart Hospital; Hematology/Oncology - Hobart
Query!
Recruitment hospital [9]
0
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [10]
0
0
Austin Hospital Olivia Newton John Cancer Centre - Heidelberg
Query!
Recruitment postcode(s) [1]
0
0
2606 - Canberra
Query!
Recruitment postcode(s) [2]
0
0
2109 - Macquarie Park
Query!
Recruitment postcode(s) [3]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [4]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [5]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [6]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [7]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [8]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [9]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [10]
0
0
3084 - Heidelberg
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
Caba
Query!
Country [3]
0
0
Argentina
Query!
State/province [3]
0
0
Ciudad Autonoma Buenos Aires
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Innsbruck
Query!
Country [5]
0
0
Austria
Query!
State/province [5]
0
0
Linz
Query!
Country [6]
0
0
Austria
Query!
State/province [6]
0
0
Salzburg
Query!
Country [7]
0
0
Austria
Query!
State/province [7]
0
0
Wien
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Brussel
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Bruxelles
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Leuven
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Liège
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
CE
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
PR
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
RS
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
SP
Query!
Country [16]
0
0
Bulgaria
Query!
State/province [16]
0
0
Plovdiv
Query!
Country [17]
0
0
Bulgaria
Query!
State/province [17]
0
0
Sofia
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Alberta
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Nova Scotia
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Ontario
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Nanjing City
Query!
Country [22]
0
0
Colombia
Query!
State/province [22]
0
0
Bogota
Query!
Country [23]
0
0
Croatia
Query!
State/province [23]
0
0
Zagreb
Query!
Country [24]
0
0
Czechia
Query!
State/province [24]
0
0
Brno
Query!
Country [25]
0
0
Czechia
Query!
State/province [25]
0
0
Praha
Query!
Country [26]
0
0
Denmark
Query!
State/province [26]
0
0
Aalborg
Query!
Country [27]
0
0
Denmark
Query!
State/province [27]
0
0
Aarhus N
Query!
Country [28]
0
0
Denmark
Query!
State/province [28]
0
0
Herlev
Query!
Country [29]
0
0
Denmark
Query!
State/province [29]
0
0
København Ø
Query!
Country [30]
0
0
Estonia
Query!
State/province [30]
0
0
Tallinn
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Dresden
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Erlangen
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Göttingen
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Halle (Saale)
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Hannover
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Heidelberg
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Lübeck
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Mönchengladbach
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
München
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Münster
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Tübingen
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Ulm
Query!
Country [43]
0
0
Greece
Query!
State/province [43]
0
0
Athens
Query!
Country [44]
0
0
Greece
Query!
State/province [44]
0
0
Kifisia
Query!
Country [45]
0
0
Greece
Query!
State/province [45]
0
0
Piraeus
Query!
Country [46]
0
0
Greece
Query!
State/province [46]
0
0
Thermi Thessalonikis
Query!
Country [47]
0
0
Greece
Query!
State/province [47]
0
0
Thessaloniki
Query!
Country [48]
0
0
Hungary
Query!
State/province [48]
0
0
Budapest
Query!
Country [49]
0
0
Hungary
Query!
State/province [49]
0
0
Szeged
Query!
Country [50]
0
0
Hungary
Query!
State/province [50]
0
0
Szolnok
Query!
Country [51]
0
0
India
Query!
State/province [51]
0
0
Delhi
Query!
Country [52]
0
0
India
Query!
State/province [52]
0
0
Gujarat
Query!
Country [53]
0
0
India
Query!
State/province [53]
0
0
Haryana
Query!
Country [54]
0
0
India
Query!
State/province [54]
0
0
WEST Bengal
Query!
Country [55]
0
0
Ireland
Query!
State/province [55]
0
0
Cork
Query!
Country [56]
0
0
Ireland
Query!
State/province [56]
0
0
Dublin
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Abruzzo
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Campania
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Emilia-Romagna
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Friuli-Venezia Giulia
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Lazio
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Liguria
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Lombardia
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Piemonte
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Puglia
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Sardegna
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Sicilia
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Toscana
Query!
Country [69]
0
0
Italy
Query!
State/province [69]
0
0
Umbria
Query!
Country [70]
0
0
Italy
Query!
State/province [70]
0
0
Veneto
Query!
Country [71]
0
0
Lebanon
Query!
State/province [71]
0
0
Beirut
Query!
Country [72]
0
0
Lithuania
Query!
State/province [72]
0
0
Kaunas
Query!
Country [73]
0
0
Lithuania
Query!
State/province [73]
0
0
Vilnius
Query!
Country [74]
0
0
Netherlands
Query!
State/province [74]
0
0
Amsterdam
Query!
Country [75]
0
0
Netherlands
Query!
State/province [75]
0
0
Groningen
Query!
Country [76]
0
0
Netherlands
Query!
State/province [76]
0
0
Maastricht
Query!
Country [77]
0
0
Netherlands
Query!
State/province [77]
0
0
Utrecht
Query!
Country [78]
0
0
Poland
Query!
State/province [78]
0
0
?ory
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Lublin
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Poznan
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Warszawa
Query!
Country [82]
0
0
Portugal
Query!
State/province [82]
0
0
Braga
Query!
Country [83]
0
0
Portugal
Query!
State/province [83]
0
0
Coimbra
Query!
Country [84]
0
0
Portugal
Query!
State/province [84]
0
0
Lisboa
Query!
Country [85]
0
0
Portugal
Query!
State/province [85]
0
0
Porto
Query!
Country [86]
0
0
Romania
Query!
State/province [86]
0
0
Baia Mare
Query!
Country [87]
0
0
Romania
Query!
State/province [87]
0
0
Cluj-Napoca
Query!
Country [88]
0
0
Romania
Query!
State/province [88]
0
0
Craiova
Query!
Country [89]
0
0
Romania
Query!
State/province [89]
0
0
Floresti
Query!
Country [90]
0
0
Romania
Query!
State/province [90]
0
0
Timisoara
Query!
Country [91]
0
0
Russian Federation
Query!
State/province [91]
0
0
Moskovskaja Oblast
Query!
Country [92]
0
0
Saudi Arabia
Query!
State/province [92]
0
0
Riyadh
Query!
Country [93]
0
0
Slovakia
Query!
State/province [93]
0
0
Bratislava
Query!
Country [94]
0
0
Spain
Query!
State/province [94]
0
0
Asturias
Query!
Country [95]
0
0
Spain
Query!
State/province [95]
0
0
Barcelona
Query!
Country [96]
0
0
Spain
Query!
State/province [96]
0
0
Cordoba
Query!
Country [97]
0
0
Spain
Query!
State/province [97]
0
0
Islas Baleares
Query!
Country [98]
0
0
Spain
Query!
State/province [98]
0
0
LA Coruña
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
Tenerife
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
Vizcaya
Query!
Country [101]
0
0
Spain
Query!
State/province [101]
0
0
Caceres
Query!
Country [102]
0
0
Spain
Query!
State/province [102]
0
0
Girona
Query!
Country [103]
0
0
Spain
Query!
State/province [103]
0
0
Guadalajara
Query!
Country [104]
0
0
Spain
Query!
State/province [104]
0
0
Lugo
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Madrid
Query!
Country [106]
0
0
Spain
Query!
State/province [106]
0
0
Malaga
Query!
Country [107]
0
0
Spain
Query!
State/province [107]
0
0
Murcia
Query!
Country [108]
0
0
Spain
Query!
State/province [108]
0
0
Navarra
Query!
Country [109]
0
0
Spain
Query!
State/province [109]
0
0
Orense
Query!
Country [110]
0
0
Spain
Query!
State/province [110]
0
0
Sevilla
Query!
Country [111]
0
0
Spain
Query!
State/province [111]
0
0
Toledo
Query!
Country [112]
0
0
Spain
Query!
State/province [112]
0
0
Valencia
Query!
Country [113]
0
0
Switzerland
Query!
State/province [113]
0
0
Basel
Query!
Country [114]
0
0
Switzerland
Query!
State/province [114]
0
0
Bellinzona
Query!
Country [115]
0
0
Switzerland
Query!
State/province [115]
0
0
Bern
Query!
Country [116]
0
0
Switzerland
Query!
State/province [116]
0
0
Chur
Query!
Country [117]
0
0
Switzerland
Query!
State/province [117]
0
0
Geneve
Query!
Country [118]
0
0
Switzerland
Query!
State/province [118]
0
0
Luzern
Query!
Country [119]
0
0
Switzerland
Query!
State/province [119]
0
0
Winterthur
Query!
Country [120]
0
0
Taiwan
Query!
State/province [120]
0
0
Tainan
Query!
Country [121]
0
0
Taiwan
Query!
State/province [121]
0
0
Taoyuan
Query!
Country [122]
0
0
United Kingdom
Query!
State/province [122]
0
0
Cardiff
Query!
Country [123]
0
0
United Kingdom
Query!
State/province [123]
0
0
Inverness
Query!
Country [124]
0
0
United Kingdom
Query!
State/province [124]
0
0
Leicester
Query!
Country [125]
0
0
United Kingdom
Query!
State/province [125]
0
0
London
Query!
Country [126]
0
0
United Kingdom
Query!
State/province [126]
0
0
Sutton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02928406
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/06/NCT02928406/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/06/NCT02928406/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02928406
Download to PDF