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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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0
2016-002625-11
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Secondary ID [2]
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MO29983
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urinary Tract Cancer
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0
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Condition category
Condition code
Cancer
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0
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Kidney
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Cancer
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0
0
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Bladder
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Adverse Events (AEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to end of study (up to approximately 6 years)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS was defined as date of death (due to any cause) or censoring minus date of start of study treatment plus 1.
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Timepoint [1]
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Randomization until death from any cause (up to approximately 6 years)
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Secondary outcome [2]
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Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Assessment method [2]
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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.
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Timepoint [2]
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Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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Secondary outcome [3]
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PFS as Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST)
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Assessment method [3]
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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
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Timepoint [3]
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Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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Secondary outcome [4]
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Percentage of Participants With Best Overall Response (BOR) as Assessed by RECIST v1.1
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Assessment method [4]
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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.
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Timepoint [4]
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Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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Secondary outcome [5]
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Percentage of Participants With BOR as Assessed by Modified RECIST
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Assessment method [5]
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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.
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Timepoint [5]
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Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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Secondary outcome [6]
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Percentage of Participants With Disease Control as Assessed by RECIST v1.1
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Assessment method [6]
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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.
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Timepoint [6]
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Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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Secondary outcome [7]
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Percentage of Participants With Disease Control as Assessed by Modified RECIST
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Assessment method [7]
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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.
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Timepoint [7]
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Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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Secondary outcome [8]
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Duration of Response (DOR) as Assessed by RECIST v1.1
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Assessment method [8]
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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).
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Timepoint [8]
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Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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Secondary outcome [9]
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DOR as Assessed by Modified RECIST
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Assessment method [9]
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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.
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Timepoint [9]
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Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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Secondary outcome [10]
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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
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Assessment method [10]
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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.
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Timepoint [10]
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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)
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Secondary outcome [11]
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Change From Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score
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Assessment method [11]
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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.
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Timepoint [11]
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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)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/11/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/12/2022
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Sample size
Target
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Accrual to date
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Final
1004
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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Canberra Hospital; Medical Oncology - Canberra
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Recruitment hospital [2]
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Macquarie University Hospital - Macquarie Park
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Recruitment hospital [3]
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Prince of Wales Hospital; Oncology - Randwick
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Recruitment hospital [4]
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Northern Cancer Institute - St Leonards
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Recruitment hospital [5]
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Calvary Mater Newcastle; Medical Oncology - Waratah
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Recruitment hospital [6]
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Icon Cancer Foundation - South Brisbane
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Recruitment hospital [7]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [8]
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Royal Hobart Hospital; Hematology/Oncology - Hobart
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Recruitment hospital [9]
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Box Hill Hospital - Box Hill
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Recruitment hospital [10]
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Austin Hospital Olivia Newton John Cancer Centre - Heidelberg
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Recruitment postcode(s) [1]
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2606 - Canberra
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Recruitment postcode(s) [2]
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2109 - Macquarie Park
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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2065 - St Leonards
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Recruitment postcode(s) [5]
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2298 - Waratah
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Recruitment postcode(s) [6]
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4101 - South Brisbane
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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7000 - Hobart
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Recruitment postcode(s) [9]
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3128 - Box Hill
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Recruitment postcode(s) [10]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Argentina
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State/province [2]
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Caba
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Argentina
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State/province [3]
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Ciudad Autonoma Buenos Aires
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Country [4]
0
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Austria
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State/province [4]
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Innsbruck
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0
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Austria
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State/province [5]
0
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Linz
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0
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Austria
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State/province [6]
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Salzburg
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0
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Austria
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State/province [7]
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Wien
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0
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Leuven
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0
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Belgium
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Liège
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Brazil
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CE
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Brazil
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PR
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Brazil
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RS
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Brazil
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SP
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Canada
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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
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Estonia
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Tallinn
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Göttingen
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Germany
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Halle (Saale)
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Germany
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Hannover
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Germany
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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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Germany
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Ulm
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Greece
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Athens
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Greece
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Kifisia
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Piraeus
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Thermi Thessalonikis
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Greece
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Thessaloniki
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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
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India
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Delhi
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India
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India
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India
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WEST Bengal
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Ireland
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Cork
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Ireland
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Italy
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Abruzzo
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Puglia
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Italy
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Sardegna
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Umbria
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Italy
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Veneto
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Lebanon
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Beirut
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Lithuania
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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
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Poland
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?ory
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Poland
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Lublin
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Poland
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Poznan
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Poland
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Warszawa
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Baia Mare
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Floresti
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Romania
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Timisoara
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Russian Federation
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Moskovskaja Oblast
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Riyadh
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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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Spain
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Tenerife
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Vizcaya
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Caceres
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Lugo
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Madrid
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Orense
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Sevilla
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Country [111]
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Toledo
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Valencia
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Switzerland
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Basel
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Country [114]
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Switzerland
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Bellinzona
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Country [115]
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Switzerland
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Bern
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Country [116]
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Switzerland
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Chur
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Country [117]
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Switzerland
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Geneve
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Switzerland
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Luzern
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Switzerland
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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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United Kingdom
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Cardiff
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United Kingdom
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Inverness
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02928406
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Contacts
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Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02928406
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