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/NCT02632409




Registration number
NCT02632409
Ethics application status
Date submitted
14/12/2015
Date registered
16/12/2015
Date last updated
8/01/2024

Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
Scientific title
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)
Secondary ID [1] 0 0
2014-003626-40
Secondary ID [2] 0 0
CA209-274
Universal Trial Number (UTN)
Trial acronym
CheckMate 274
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Nivolumab - Nivolumab dose as specified

Placebo comparator: Placebo - Placebo dose as specified
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease Free Survival (DFS)
Timepoint [1] 0 0
approximately up to 48 months
Primary outcome [2] 0 0
Disease Free Survival (DFS) in PD-L1 Expression = 1% Population
Timepoint [2] 0 0
approximately up to 48 months
Secondary outcome [1] 0 0
Non-Urothelial Tract Recurrence Free Survival
Timepoint [1] 0 0
up to 53 months
Secondary outcome [2] 0 0
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression = 1% Population
Timepoint [2] 0 0
up to 53 months
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
on going
Secondary outcome [4] 0 0
Overall Survival in Participants With PD-L1 Expression = 1%
Timepoint [4] 0 0
on going
Secondary outcome [5] 0 0
Disease Specific Survival
Timepoint [5] 0 0
on going
Secondary outcome [6] 0 0
Disease Specific Survival in Participants With PD-L1 Expression = 1%
Timepoint [6] 0 0
on going

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com



* Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
* Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
* Must have disease free status as determined by imaging within 4 weeks of dosing
* Tumor tissue must be provided for biomarker analysis
* Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
* Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
* Subjects with active, known or suspected autoimmune disease
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
* Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
* Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
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
22/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/05/2027
Actual
Sample size
Target
Accrual to date
Final
709
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0048 - Liverpool
Recruitment hospital [2] 0 0
Local Institution - 0047 - St. Leonards
Recruitment hospital [3] 0 0
Local Institution - 0046 - Waratah
Recruitment hospital [4] 0 0
Local Institution - 0050 - Elizabeth Vale
Recruitment hospital [5] 0 0
Local Institution - 0184 - Frankston
Recruitment hospital [6] 0 0
Local Institution - 0175 - Perth
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
6150 - Perth
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
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
Tucuman
Country [23] 0 0
Austria
State/province [23] 0 0
Linz
Country [24] 0 0
Austria
State/province [24] 0 0
Salzburg
Country [25] 0 0
Austria
State/province [25] 0 0
Vienna
Country [26] 0 0
Austria
State/province [26] 0 0
Wien
Country [27] 0 0
Belgium
State/province [27] 0 0
Hasselt
Country [28] 0 0
Belgium
State/province [28] 0 0
Liege
Country [29] 0 0
Brazil
State/province [29] 0 0
RIO Grande DO SUL
Country [30] 0 0
Brazil
State/province [30] 0 0
Sao Paulo
Country [31] 0 0
Brazil
State/province [31] 0 0
SAO Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio De Janeiro
Country [33] 0 0
Brazil
State/province [33] 0 0
São Paulo
Country [34] 0 0
Canada
State/province [34] 0 0
Alberta
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Canada
State/province [36] 0 0
Montreal
Country [37] 0 0
Chile
State/province [37] 0 0
Metropolitana
Country [38] 0 0
Chile
State/province [38] 0 0
Valparaiso
Country [39] 0 0
Chile
State/province [39] 0 0
Temuco
Country [40] 0 0
China
State/province [40] 0 0
Beijing
Country [41] 0 0
China
State/province [41] 0 0
Chongqing
Country [42] 0 0
China
State/province [42] 0 0
Fujian
Country [43] 0 0
China
State/province [43] 0 0
Guangdong
Country [44] 0 0
China
State/province [44] 0 0
Guangxi
Country [45] 0 0
China
State/province [45] 0 0
Hubei
Country [46] 0 0
China
State/province [46] 0 0
Jiangsu
Country [47] 0 0
China
State/province [47] 0 0
Jiangxi
Country [48] 0 0
China
State/province [48] 0 0
Shan3xi
Country [49] 0 0
China
State/province [49] 0 0
Shandong
Country [50] 0 0
China
State/province [50] 0 0
Shanghai
Country [51] 0 0
China
State/province [51] 0 0
Sichuan
Country [52] 0 0
China
State/province [52] 0 0
Zhejiang
Country [53] 0 0
Colombia
State/province [53] 0 0
Bogota
Country [54] 0 0
Colombia
State/province [54] 0 0
Floridablanca
Country [55] 0 0
Colombia
State/province [55] 0 0
Medellin
Country [56] 0 0
Denmark
State/province [56] 0 0
Aalborg
Country [57] 0 0
Denmark
State/province [57] 0 0
Aarhus N
Country [58] 0 0
Denmark
State/province [58] 0 0
Copenhagen
Country [59] 0 0
France
State/province [59] 0 0
Clermont-ferrand
Country [60] 0 0
France
State/province [60] 0 0
La Roche-sur-Yon
Country [61] 0 0
France
State/province [61] 0 0
Marseille Cedex 9
Country [62] 0 0
France
State/province [62] 0 0
Paris
Country [63] 0 0
France
State/province [63] 0 0
Strasbourg
Country [64] 0 0
France
State/province [64] 0 0
Suresnes
Country [65] 0 0
France
State/province [65] 0 0
Villejuif
Country [66] 0 0
Germany
State/province [66] 0 0
Chemnitz
Country [67] 0 0
Germany
State/province [67] 0 0
Essen
Country [68] 0 0
Germany
State/province [68] 0 0
Greifswald
Country [69] 0 0
Germany
State/province [69] 0 0
Hamburg
Country [70] 0 0
Germany
State/province [70] 0 0
Heidelberg
Country [71] 0 0
Germany
State/province [71] 0 0
Jena
Country [72] 0 0
Germany
State/province [72] 0 0
Marburg
Country [73] 0 0
Germany
State/province [73] 0 0
Muenster
Country [74] 0 0
Germany
State/province [74] 0 0
Munich
Country [75] 0 0
Germany
State/province [75] 0 0
Nuernberg
Country [76] 0 0
Germany
State/province [76] 0 0
Regensburg
Country [77] 0 0
Germany
State/province [77] 0 0
Stuttgart
Country [78] 0 0
Greece
State/province [78] 0 0
Athens
Country [79] 0 0
Greece
State/province [79] 0 0
Thessaloniki
Country [80] 0 0
Ireland
State/province [80] 0 0
Cork
Country [81] 0 0
Ireland
State/province [81] 0 0
Dublin
Country [82] 0 0
Israel
State/province [82] 0 0
Haifa
Country [83] 0 0
Israel
State/province [83] 0 0
Jerusalem
Country [84] 0 0
Israel
State/province [84] 0 0
Ramat Gan
Country [85] 0 0
Israel
State/province [85] 0 0
Zerifin
Country [86] 0 0
Italy
State/province [86] 0 0
Arezzo
Country [87] 0 0
Italy
State/province [87] 0 0
Bergamo
Country [88] 0 0
Italy
State/province [88] 0 0
Milano
Country [89] 0 0
Italy
State/province [89] 0 0
Pisa
Country [90] 0 0
Italy
State/province [90] 0 0
Reggio Emilia
Country [91] 0 0
Italy
State/province [91] 0 0
Roma
Country [92] 0 0
Italy
State/province [92] 0 0
Siena
Country [93] 0 0
Japan
State/province [93] 0 0
Akita
Country [94] 0 0
Japan
State/province [94] 0 0
Aomori
Country [95] 0 0
Japan
State/province [95] 0 0
Fukuoka
Country [96] 0 0
Japan
State/province [96] 0 0
Hokkaido
Country [97] 0 0
Japan
State/province [97] 0 0
Ibaraki
Country [98] 0 0
Japan
State/province [98] 0 0
Nagasaki
Country [99] 0 0
Japan
State/province [99] 0 0
Niigata
Country [100] 0 0
Japan
State/province [100] 0 0
Okayama
Country [101] 0 0
Japan
State/province [101] 0 0
Osaka
Country [102] 0 0
Japan
State/province [102] 0 0
Shizuoka
Country [103] 0 0
Japan
State/province [103] 0 0
Tokyo
Country [104] 0 0
Japan
State/province [104] 0 0
Chiba
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Seongnam-si
Country [106] 0 0
Korea, Republic of
State/province [106] 0 0
Seoul
Country [107] 0 0
Mexico
State/province [107] 0 0
Distrito Federal
Country [108] 0 0
Mexico
State/province [108] 0 0
Jalisco
Country [109] 0 0
Mexico
State/province [109] 0 0
Nuevo Leon
Country [110] 0 0
Netherlands
State/province [110] 0 0
Amsterdam
Country [111] 0 0
Netherlands
State/province [111] 0 0
Maastrict
Country [112] 0 0
Netherlands
State/province [112] 0 0
Nijmegen
Country [113] 0 0
Peru
State/province [113] 0 0
Lima
Country [114] 0 0
Poland
State/province [114] 0 0
Gdansk
Country [115] 0 0
Poland
State/province [115] 0 0
Lodz
Country [116] 0 0
Poland
State/province [116] 0 0
Warsaw
Country [117] 0 0
Poland
State/province [117] 0 0
Wroclaw
Country [118] 0 0
Romania
State/province [118] 0 0
Bucuresti
Country [119] 0 0
Romania
State/province [119] 0 0
Craiova
Country [120] 0 0
Romania
State/province [120] 0 0
Floresti
Country [121] 0 0
Romania
State/province [121] 0 0
Timisoara, Timis
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Moscow
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Saint-Petersburg
Country [124] 0 0
Spain
State/province [124] 0 0
Badalona-barcelona
Country [125] 0 0
Spain
State/province [125] 0 0
Barcelona
Country [126] 0 0
Spain
State/province [126] 0 0
Madrid
Country [127] 0 0
Spain
State/province [127] 0 0
Santander
Country [128] 0 0
Spain
State/province [128] 0 0
Sevilla
Country [129] 0 0
Sweden
State/province [129] 0 0
Lund
Country [130] 0 0
Switzerland
State/province [130] 0 0
Basel
Country [131] 0 0
Switzerland
State/province [131] 0 0
Zuerich
Country [132] 0 0
Taiwan
State/province [132] 0 0
Kaohsiung
Country [133] 0 0
Taiwan
State/province [133] 0 0
Taichung
Country [134] 0 0
Taiwan
State/province [134] 0 0
Taipei
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Greater Manchester
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Midlothian
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Surrey
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Yorkshire
Country [139] 0 0
United Kingdom
State/province [139] 0 0
London

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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02632409