Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03036098




Registration number
NCT03036098
Ethics application status
Date submitted
27/01/2017
Date registered
30/01/2017
Date last updated
23/10/2024

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
Treatment: Other - Nivolumab
Treatment: Other - 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 -


Treatment: Other: Nivolumab
Specified Dose on Specified Days

Treatment: Other: 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
Treatment: Other
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
Accrual to date
Final
1322
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
RIO Negro
Country [22] 0 0
Argentina
State/province [22] 0 0
Cordoba
Country [23] 0 0
Brazil
State/province [23] 0 0
Distrito Federal
Country [24] 0 0
Brazil
State/province [24] 0 0
RIO Grande DO SUL
Country [25] 0 0
Brazil
State/province [25] 0 0
Santa Catarina
Country [26] 0 0
Brazil
State/province [26] 0 0
Sao Paulo
Country [27] 0 0
Canada
State/province [27] 0 0
Nova Scotia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Chile
State/province [30] 0 0
Metropolitana
Country [31] 0 0
Chile
State/province [31] 0 0
Valparaiso
Country [32] 0 0
Chile
State/province [32] 0 0
Vitacura
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
China
State/province [34] 0 0
Chongqing
Country [35] 0 0
China
State/province [35] 0 0
Guizhou
Country [36] 0 0
China
State/province [36] 0 0
Heilongjiang
Country [37] 0 0
China
State/province [37] 0 0
Hubei
Country [38] 0 0
China
State/province [38] 0 0
Jiangsu
Country [39] 0 0
China
State/province [39] 0 0
Jilin
Country [40] 0 0
China
State/province [40] 0 0
Shan1xi
Country [41] 0 0
China
State/province [41] 0 0
Shandong
Country [42] 0 0
China
State/province [42] 0 0
Shanghai
Country [43] 0 0
China
State/province [43] 0 0
Sichuan
Country [44] 0 0
China
State/province [44] 0 0
Zhejiang
Country [45] 0 0
Czechia
State/province [45] 0 0
Brno
Country [46] 0 0
Czechia
State/province [46] 0 0
Hradec Kralove
Country [47] 0 0
Denmark
State/province [47] 0 0
Aalborg
Country [48] 0 0
Denmark
State/province [48] 0 0
Herlev
Country [49] 0 0
Finland
State/province [49] 0 0
Helsinki
Country [50] 0 0
France
State/province [50] 0 0
Gard
Country [51] 0 0
France
State/province [51] 0 0
Lille
Country [52] 0 0
France
State/province [52] 0 0
Marseille Cedex 9
Country [53] 0 0
France
State/province [53] 0 0
St Priest En Jarez
Country [54] 0 0
France
State/province [54] 0 0
Suresnes
Country [55] 0 0
France
State/province [55] 0 0
Tours Cedex
Country [56] 0 0
France
State/province [56] 0 0
Villejuif
Country [57] 0 0
Germany
State/province [57] 0 0
Dresden
Country [58] 0 0
Germany
State/province [58] 0 0
Essen
Country [59] 0 0
Germany
State/province [59] 0 0
Freiburg
Country [60] 0 0
Germany
State/province [60] 0 0
Hamburg
Country [61] 0 0
Germany
State/province [61] 0 0
Hannover
Country [62] 0 0
Germany
State/province [62] 0 0
Jena
Country [63] 0 0
Germany
State/province [63] 0 0
Mannheim
Country [64] 0 0
Germany
State/province [64] 0 0
Nuernberg
Country [65] 0 0
Germany
State/province [65] 0 0
Tuebingen
Country [66] 0 0
Germany
State/province [66] 0 0
Weiden
Country [67] 0 0
Germany
State/province [67] 0 0
Wuerzburg
Country [68] 0 0
Greece
State/province [68] 0 0
Athens
Country [69] 0 0
Greece
State/province [69] 0 0
Ípeiros
Country [70] 0 0
Israel
State/province [70] 0 0
Kfar Saba
Country [71] 0 0
Israel
State/province [71] 0 0
Ramat Gan
Country [72] 0 0
Italy
State/province [72] 0 0
Arezzo
Country [73] 0 0
Italy
State/province [73] 0 0
Faenza
Country [74] 0 0
Italy
State/province [74] 0 0
Forlì
Country [75] 0 0
Italy
State/province [75] 0 0
Grosseto
Country [76] 0 0
Italy
State/province [76] 0 0
Milano
Country [77] 0 0
Italy
State/province [77] 0 0
Napoli
Country [78] 0 0
Japan
State/province [78] 0 0
Aomori
Country [79] 0 0
Japan
State/province [79] 0 0
Chiba
Country [80] 0 0
Japan
State/province [80] 0 0
Ehime
Country [81] 0 0
Japan
State/province [81] 0 0
Fukuoka
Country [82] 0 0
Japan
State/province [82] 0 0
Hokkaido
Country [83] 0 0
Japan
State/province [83] 0 0
Ibaraki
Country [84] 0 0
Japan
State/province [84] 0 0
Iwate
Country [85] 0 0
Japan
State/province [85] 0 0
Kagawa
Country [86] 0 0
Japan
State/province [86] 0 0
Niigata
Country [87] 0 0
Japan
State/province [87] 0 0
Okayama
Country [88] 0 0
Japan
State/province [88] 0 0
Osaka
Country [89] 0 0
Japan
State/province [89] 0 0
Shizuoka
Country [90] 0 0
Japan
State/province [90] 0 0
Tokyo
Country [91] 0 0
Japan
State/province [91] 0 0
Wakayama
Country [92] 0 0
Japan
State/province [92] 0 0
Yamaguchi
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Gyeonggido
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Seongnam-si
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Seoul
Country [96] 0 0
Mexico
State/province [96] 0 0
Distrito Federal
Country [97] 0 0
Mexico
State/province [97] 0 0
Nuevo Leon
Country [98] 0 0
Netherlands
State/province [98] 0 0
Noord-Holland
Country [99] 0 0
Netherlands
State/province [99] 0 0
Enschede
Country [100] 0 0
Netherlands
State/province [100] 0 0
Groningen
Country [101] 0 0
Netherlands
State/province [101] 0 0
Leeuwarden
Country [102] 0 0
Norway
State/province [102] 0 0
Bergen
Country [103] 0 0
Norway
State/province [103] 0 0
Lorenskog
Country [104] 0 0
Peru
State/province [104] 0 0
Lima
Country [105] 0 0
Poland
State/province [105] 0 0
Bydgoszcz
Country [106] 0 0
Poland
State/province [106] 0 0
Koszalin
Country [107] 0 0
Poland
State/province [107] 0 0
Warszawa
Country [108] 0 0
Romania
State/province [108] 0 0
Cluj
Country [109] 0 0
Romania
State/province [109] 0 0
Dolj
Country [110] 0 0
Russian Federation
State/province [110] 0 0
Moscow
Country [111] 0 0
Singapore
State/province [111] 0 0
Central Singapore
Country [112] 0 0
Spain
State/province [112] 0 0
A Coruna
Country [113] 0 0
Spain
State/province [113] 0 0
Barcelona
Country [114] 0 0
Spain
State/province [114] 0 0
Madrid
Country [115] 0 0
Spain
State/province [115] 0 0
Santander
Country [116] 0 0
Spain
State/province [116] 0 0
Sevilla
Country [117] 0 0
Spain
State/province [117] 0 0
Valencia
Country [118] 0 0
Sweden
State/province [118] 0 0
Jonkoping
Country [119] 0 0
Sweden
State/province [119] 0 0
Linkoping
Country [120] 0 0
Sweden
State/province [120] 0 0
Lund
Country [121] 0 0
Switzerland
State/province [121] 0 0
Aargau
Country [122] 0 0
Switzerland
State/province [122] 0 0
Chur
Country [123] 0 0
Taiwan
State/province [123] 0 0
Kaohsiung
Country [124] 0 0
Taiwan
State/province [124] 0 0
Taichung
Country [125] 0 0
Taiwan
State/province [125] 0 0
Taipei
Country [126] 0 0
Taiwan
State/province [126] 0 0
Taoyuan
Country [127] 0 0
Turkey
State/province [127] 0 0
Ankara
Country [128] 0 0
Turkey
State/province [128] 0 0
Istanbul
Country [129] 0 0
Turkey
State/province [129] 0 0
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/study/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/study/NCT03036098