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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/NCT03036098




Registration number
NCT03036098
Ethics application status
Date submitted
27/01/2017
Date registered
30/01/2017
Date last updated
10/04/2024

Titles & IDs
Public title
Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer
Scientific title
A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer
Secondary ID [1] 0 0
2016-003881-14
Secondary ID [2] 0 0
CA209-901
Universal Trial Number (UTN)
Trial acronym
CheckMate901
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 - Nivolumab
Other interventions - Ipilimumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin

Experimental: Arm A: Investigational immunotherapy -

Active Comparator: Arm B: Standard of care chemotherapy -

Experimental: Arm C: Investigational immunotherapy -

Active Comparator: Arm D: Standard of care chemotherapy -


Other interventions: Nivolumab
Specified Dose on Specified Days

Other interventions: Ipilimumab
Specified Dose on Specified Days

Treatment: Drugs: Gemcitabine
Specified Dose on Specified Days

Treatment: Drugs: Cisplatin
Specified Dose on Specified Days

Treatment: Drugs: Carboplatin
Specified Dose on Specified Days
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS) in cisplatin-ineligible randomized participants
Timepoint [1] 0 0
Up to 55 months
Primary outcome [2] 0 0
Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC)
Timepoint [2] 0 0
Up to 52 months
Primary outcome [3] 0 0
Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC
Timepoint [3] 0 0
Up to 64 months
Primary outcome [4] 0 0
Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC
Timepoint [4] 0 0
Up to 64 months
Secondary outcome [1] 0 0
Overall survival (OS) in all randomized participants
Timepoint [1] 0 0
Up to 55 months
Secondary outcome [2] 0 0
Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants
Timepoint [2] 0 0
Up to 55 months
Secondary outcome [3] 0 0
Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PD-L1 positive (=1%) randomized participants
Timepoint [3] 0 0
Up to 55 months
Secondary outcome [4] 0 0
Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants
Timepoint [4] 0 0
Up to 55 months
Secondary outcome [5] 0 0
European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants
Timepoint [5] 0 0
Up to 55 months
Secondary outcome [6] 0 0
European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC
Timepoint [6] 0 0
Up to 64 months
Secondary outcome [7] 0 0
Progression-free survival (PFS) by BICR by PD-L1 expression at >=1% by immunohistochemistry (IHC)
Timepoint [7] 0 0
Up to 64 months
Secondary outcome [8] 0 0
Overall survival (OS) by PD-L1 expression at = 1% expression by immunohistochemistry (IHC)
Timepoint [8] 0 0
Up to 64 months

Eligibility
Key inclusion criteria
- Histological or cytological evidence of metastatic or surgically inoperable
transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter,
bladder or urethra

- No prior systemic chemotherapy for metastatic or surgically inoperable urothelial
cancer (UC)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

- Women and men must agree to follow specific methods of contraception, if applicable
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Disease that is suitable for local therapy administered with curative intent

- Any serious or uncontrolled medical disorder in the opinion of the investigator that
may increase the risk associated with study participation or study drug administration
or interfere with the interpretation of study results

- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4
antibody, or any other antibody or drug specifically targeting T-cell co-stimulation
or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

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
24/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
1290
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0096 - Waratah
Recruitment hospital [2] 0 0
Local Institution - 0099 - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0188 - South Brisbane
Recruitment hospital [4] 0 0
Local Institution - 0120 - Tugun
Recruitment hospital [5] 0 0
Local Institution - 0101 - Heidelberg
Recruitment hospital [6] 0 0
Local Institution - 0100 - Doubleview
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4224 - Tugun
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
6018 - Doubleview
Recruitment outside Australia
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United States of America
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Alaska
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California
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Louisiana
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Massachusetts
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Michigan
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Missouri
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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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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RIO Negro
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Argentina
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Cordoba
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Brazil
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Distrito Federal
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Brazil
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RIO Grande DO SUL
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Brazil
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Santa Catarina
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Brazil
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Sao Paulo
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Canada
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Nova Scotia
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Ontario
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Quebec
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Chile
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Metropolitana
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Chile
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Valparaiso
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Chile
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Vitacura
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Beijing
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Jilin
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Shan1xi
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Sichuan
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Zhejiang
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Denmark
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Aalborg
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Herlev
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Finland
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Helsinki
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Gard
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France
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Lille
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France
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Marseille Cedex 9
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France
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St Priest En Jarez
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Suresnes
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France
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Tours Cedex
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France
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Villejuif
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Germany
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Dresden
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Essen
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Freiburg
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Hannover
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Jena
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Mannheim
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Germany
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Nuernberg
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Germany
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Tuebingen
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Germany
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Weiden
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Germany
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Wuerzburg
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Greece
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Athens
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Greece
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Ípeiros
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Italy
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Arezzo
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Italy
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Faenza
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Italy
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Forlì
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Italy
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Grosseto
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Milano
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Napoli
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Aomori
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Chiba
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Ehime
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Fukuoka
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Hokkaido
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Ibaraki
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Iwate
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Kagawa
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Niigata
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Okayama
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Osaka
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Shizuoka
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Tokyo
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Wakayama
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Yamaguchi
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Korea, Republic of
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Gyeonggido
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Seongnam-si
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Nuevo Leon
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Netherlands
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Amsterdam
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Enschede
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Groningen
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Leeuwarden
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Bergen
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Lorenskog
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Peru
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Lima
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Bydgoszcz
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Koszalin
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Poland
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Warszawa
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Romania
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Cluj
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Romania
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Craiova
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Russian Federation
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Moscow
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Singapore
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Central Singapore
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Spain
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A Coruna
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Jonkoping
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Sweden
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Linkoping
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Sweden
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Lund
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Switzerland
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Baden
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Switzerland
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Chur
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether an investigational immunotherapy nivolumab
in combination with ipilimumab or in combination with standard of care chemotherapy is more
effective than standard of care chemotherapy alone in treating participants with previously
untreated inoperable or metastatic urothelial cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03036098
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03036098