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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02603432




Registration number
NCT02603432
Ethics application status
Date submitted
9/11/2015
Date registered
11/11/2015
Date last updated
1/07/2020

Titles & IDs
Public title
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
Scientific title
A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY
Secondary ID [1] 0 0
2015-003262-86
Secondary ID [2] 0 0
B9991001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Avelumab
Other interventions - Best Supportive Care
Other interventions - Following the planned interim analysis for this study: Avelumab

Experimental: Arm A - Avelumab plus Best Supportive Care (BSC)

Other: Arm B - Best Supportive Care (BSC) alone
Following the planned interim analysis for this study, eligible patients in Arm B whose cancer has not worsened and are still in the "watch and wait" part of the study will be given the option to receive Avelumab plus BSC. Prior to this, Arm B patients received BSC alone.


Other interventions: Avelumab
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles

Other interventions: Best Supportive Care
BSC will be administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. BSC does not include any active anti-tumor therapy, however local radiotherapy of isolated lesions with palliative intent is acceptable.

Other interventions: Following the planned interim analysis for this study: Avelumab
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival - Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Patients last known to be alive will be censored at date of last contact.
Timepoint [1] 0 0
Up to approximately 40 months
Secondary outcome [1] 0 0
Progression-Free Survival - Progression-free survival (PFS) is defined as the time from randomization to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever occurs first.
Timepoint [1] 0 0
Up to approximately 60 months
Secondary outcome [2] 0 0
Objective Response - Objective response (OR) is defined as a complete response (CR) or partial response (PR) according to RECIST v1.1 recorded from date of randomization until disease progression or death due to any cause.
Timepoint [2] 0 0
Up to approximately 60 months
Secondary outcome [3] 0 0
Duration of Response - Duration of response (DR) is defined, for patients with an objective response per RECIST v1.1, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
Timepoint [3] 0 0
Up to approximately 60 months
Secondary outcome [4] 0 0
Disease Control - Disease control (DC) is defined as CR, PR, non-CR/non-PD, or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression or death due to any cause.
Timepoint [4] 0 0
Up to approximately 60 months
Secondary outcome [5] 0 0
Cmax - Cmax defined as the maximum plasma concentration of avelumab.
Timepoint [5] 0 0
Up to approximately 60 months
Secondary outcome [6] 0 0
Ctrough - Ctrough is defined as the trough plasma concentrate at the end of an avelumab dosing interval.
Timepoint [6] 0 0
Up to approximately 60 months
Secondary outcome [7] 0 0
Incidence of Anti-Drug Antibody - Percentage of patients receiving avelumab with positive anti-Drug Antibody (ADA) and neutralizing antibodies.
Timepoint [7] 0 0
Up to approximately 60 months
Secondary outcome [8] 0 0
Tumor Tissue Biomarkers - Analyses to evaluate candidate predictive biomarkers of sensitivity or resistance to avelumab, including but not limited to PD-L1 expression.
Timepoint [8] 0 0
Up to approximately 60 months
Secondary outcome [9] 0 0
Functional Assessment of Cancer Therapy - Bladder Cancer - To assess disease-related symptoms.
Timepoint [9] 0 0
Up to approximately 60 months
Secondary outcome [10] 0 0
EuroQoL EQ-5D - To assess health status.
Timepoint [10] 0 0
Up to approximately 60 months

Eligibility
Key inclusion criteria
- Histologically confirmed, unresectable locally advanced or metastatic transitional
cell carcinoma of the urothelium

- Stage IV disease at the start of first-line chemotherapy

- Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy

- Prior first-line chemotherapy must have consisted of at least 4 cycles and no more
than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin

- No evidence of progressive disease following completion of first-line chemotherapy
(i.e., ongoing CR, PR, or SD per RECIST v1.1 guidelines )
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization

- Prior immunotherapy with IL-2, IFN-a, or an anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug
specifically targeting T-cell co-stimulation or immune checkpoint pathways

- Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however,
alopecia, sensory neuropathy (Grade 2 or less), or other (Grade 2 or less) adverse
events not constituting a safety risk based on the investigator's judgement are
acceptable.

- Patients with known symptomatic central nervous system (CNS) metastases requiring
steroids

- Diagnosis of any other malignancy within 5 years prior to randomization, except for
adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the
breast or of the cervix, low grade prostate cancer on surveillance without any plans
for treatment intervention, or prostate cancer that has been adequately treated with
prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [4] 0 0
Ramsay Pharmacy - Kogarah
Recruitment hospital [5] 0 0
St George Private Hospital - Kogarah
Recruitment hospital [6] 0 0
Epic Pharmacy - Lismore
Recruitment hospital [7] 0 0
North Coast Radiology St Vincents - Lismore
Recruitment hospital [8] 0 0
Northern Rivers Pathology Service - Lismore
Recruitment hospital [9] 0 0
St Vincent's Pathology Lismore - Lismore
Recruitment hospital [10] 0 0
Macquarie University Hospital Pharmacy - Macquarie University
Recruitment hospital [11] 0 0
Macquarie University - Macquarie University
Recruitment hospital [12] 0 0
Slade Pharmacy - Mount Kuring-Gai
Recruitment hospital [13] 0 0
The Murwillumbah Hospital - Murwillubah
Recruitment hospital [14] 0 0
Macquarie Medical Imaging - North Ryde
Recruitment hospital [15] 0 0
The Tweed Hospital Pharmacy Department - Tweed Heads
Recruitment hospital [16] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [17] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [18] 0 0
River City Pharmacy - Auchenflower
Recruitment hospital [19] 0 0
Oncology Pharmacy - Birtinya
Recruitment hospital [20] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [21] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [22] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [23] 0 0
Slade Health - Geebung
Recruitment hospital [24] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [25] 0 0
Icon Cancer Care - South Brisbane
Recruitment hospital [26] 0 0
Icon Cancer Care Southport - Southport
Recruitment hospital [27] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [28] 0 0
SA Pharmacy, Level 3 Pharmacy - Bedford Park
Recruitment hospital [29] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [30] 0 0
Ashford Cancer Centre Research - Kurralta park
Recruitment hospital [31] 0 0
Cancer Care SA Pty Ltd - Kurralta Park
Recruitment hospital [32] 0 0
Icon Cancer Care SA trading as Icon Pharmacy Adelaide - Kurralta Park
Recruitment hospital [33] 0 0
Queen Elizabeth Hospital - Woodville South
Recruitment hospital [34] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [35] 0 0
BHS Diagnostic Services - Ballarat
Recruitment hospital [36] 0 0
Lake Imaging - Ballarat
Recruitment hospital [37] 0 0
Ballarat Oncology & Haematology Services - Ballarat
Recruitment hospital [38] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [39] 0 0
Eastern Health Clinical School - Box Hill
Recruitment hospital [40] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [41] 0 0
Monash Cancer Centre - East Bentleigh
Recruitment hospital [42] 0 0
Moorabbin Radiology - East Bentleigh
Recruitment hospital [43] 0 0
Ballarat Day Procedure Centre - Wendouree
Recruitment hospital [44] 0 0
Ballarat Oncology & Haematology Services - Wendouree
Recruitment hospital [45] 0 0
Nova Pharmacy - Wendouree
Recruitment hospital [46] 0 0
SKG Radiology - Murdoch
Recruitment hospital [47] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [48] 0 0
St John of God Murdoch Hospital - Murdoch
Recruitment hospital [49] 0 0
Slade Health - Mount Waverley
Recruitment hospital [50] 0 0
Macquarie Heart - New South Wales
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2830 - Dubbo
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2480 - Lismore
Recruitment postcode(s) [6] 0 0
2109 - Macquarie University
Recruitment postcode(s) [7] 0 0
2080 - Mount Kuring-Gai
Recruitment postcode(s) [8] 0 0
2484 - Murwillubah
Recruitment postcode(s) [9] 0 0
2109 - North Ryde
Recruitment postcode(s) [10] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [11] 0 0
4066 - Auchenflower
Recruitment postcode(s) [12] 0 0
4575 - Birtinya
Recruitment postcode(s) [13] 0 0
4032 - Chermside
Recruitment postcode(s) [14] 0 0
4814 - Douglas
Recruitment postcode(s) [15] 0 0
4034 - Geebung
Recruitment postcode(s) [16] 0 0
4101 - South Brisbane
Recruitment postcode(s) [17] 0 0
4215 - Southport
Recruitment postcode(s) [18] 0 0
5042 - Bedford Park
Recruitment postcode(s) [19] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [20] 0 0
5037 - Kurralta park
Recruitment postcode(s) [21] 0 0
5011 - Woodville South
Recruitment postcode(s) [22] 0 0
3350 - Ballarat
Recruitment postcode(s) [23] 0 0
3355 - Ballarat
Recruitment postcode(s) [24] 0 0
3128 - Box Hill
Recruitment postcode(s) [25] 0 0
3168 - Clayton
Recruitment postcode(s) [26] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [27] 0 0
3355 - Wendouree
Recruitment postcode(s) [28] 0 0
6050 - Murdoch
Recruitment postcode(s) [29] 0 0
6150 - Murdoch
Recruitment postcode(s) [30] 0 0
3149 - Mount Waverley
Recruitment postcode(s) [31] 0 0
2109 - New South Wales
Recruitment outside Australia
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United States of America
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Colorado
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United States of America
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Connecticut
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Massachusetts
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Minnesota
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Ohio
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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La Rioja
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Belgium
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Brasschaat
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Ghent
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Belgium
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Kortrijk
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Belgium
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Liège
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Belgium
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Wilrijk
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Brazil
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BA
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Brazil
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RIO Grande DO SUL
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Brazil
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RJ
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Brazil
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RS
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Brno
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Czechia
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Horovice
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Aalborg
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Denmark
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Aarhus C
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Denmark
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Aarhus N
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Denmark
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Copenhagen
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Cedex 13
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Lille
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Lyon cedex 8
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LYON cedex 8
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Marseille cedex 5
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Marseille Cedex 9
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Marseille
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Nimes
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PARIS cedex 13
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Paris
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Rennes Cedex
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Rouen Cedex 1
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Rouen
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Greece
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Cholargos
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Greece
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Patra
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Greece
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Thessaloniki
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Hong Kong
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Hong Kong
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Hungary
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India
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India
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WEST Bengal
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Israel
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Jerusalem
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Israel
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Ramat - GAN
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Beer Yaakov
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Israel
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Haifa
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Israel
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Italy
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(torino)
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Italy
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Ancona
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Italy
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Forli-cesena
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Italy
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Milan
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Italy
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Ravenna
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Torino
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Arezzo
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Aviano (PN)
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Italy
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Bologna
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Genova
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Naples
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Pisa
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Rome
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Italy
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Terni
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Aichi
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Aomori
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Ehime
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Gunma
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New Zealand
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New Zealand
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New Zealand
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Hamilton
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Norway
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Lorenskog
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Norway
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Nordbyhagen
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Norway
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Stavanger
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Lublin
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Poland
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Portugal
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Coimbra
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Lisboa
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Portugal
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Porto
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Portugal
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Vila Real
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Russian Federation
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Nis
Country [154] 0 0
Serbia
State/province [154] 0 0
Sremska Kamenica
Country [155] 0 0
Spain
State/province [155] 0 0
A Coruña
Country [156] 0 0
Spain
State/province [156] 0 0
Alicante
Country [157] 0 0
Spain
State/province [157] 0 0
Asturias
Country [158] 0 0
Spain
State/province [158] 0 0
Barcelona
Country [159] 0 0
Spain
State/province [159] 0 0
Comunidad Valenciana
Country [160] 0 0
Spain
State/province [160] 0 0
Galicia
Country [161] 0 0
Spain
State/province [161] 0 0
Madrid
Country [162] 0 0
Spain
State/province [162] 0 0
Navarra
Country [163] 0 0
Spain
State/province [163] 0 0
Badajoz
Country [164] 0 0
Spain
State/province [164] 0 0
Cordoba
Country [165] 0 0
Spain
State/province [165] 0 0
Gerona
Country [166] 0 0
Spain
State/province [166] 0 0
Lugo
Country [167] 0 0
Spain
State/province [167] 0 0
Sevilla
Country [168] 0 0
Spain
State/province [168] 0 0
Valencia
Country [169] 0 0
Sweden
State/province [169] 0 0
Stockholm
Country [170] 0 0
Taiwan
State/province [170] 0 0
Taichung
Country [171] 0 0
Taiwan
State/province [171] 0 0
Tainan
Country [172] 0 0
Taiwan
State/province [172] 0 0
Taipei
Country [173] 0 0
Taiwan
State/province [173] 0 0
Taoyuan
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Bath
Country [175] 0 0
United Kingdom
State/province [175] 0 0
London
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to compare maintenance treatment with avelumab plus best
supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in
patients with locally advanced or metastatic urothelial cancer that did not worsen during or
following completion of first-line chemotherapy.
Trial website
https://clinicaltrials.gov/show/NCT02603432
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications