Clinical trial NCT02632409: 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
Official 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Various Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2015-12-16
Enrollment: 709
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.


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

Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: approximately up to 48 months
measure: Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
timeFrame: approximately up to 48 months
Secondary outcomes:
measure: Non-Urothelial Tract Recurrence Free Survival
timeFrame: up to 53 months
measure: Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population
timeFrame: up to 53 months
measure: Overall Survival
timeFrame: on going
measure: Overall Survival in Participants With PD-L1 Expression ≥ 1%
timeFrame: on going
measure: Disease Specific Survival
timeFrame: on going
measure: Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%
timeFrame: on going
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Urological Institute dba Alaska Clinical Research Center
state: Alaska
city: Tucson
country: United States
facility: Local Institution - 0179
state: Arizona
city: Clovis
country: United States
facility: Local Institution - 0061
state: California
city: Sacramento
country: United States
facility: Local Institution - 0172
state: California
city: San Francisco
country: United States
facility: Local Institution - 0005
state: California
city: Lakewood
country: United States
facility: Local Institution - 0178
state: Colorado
city: Gainesville
country: United States
facility: Local Institution - 0167
state: Florida
city: Miami Beach
country: United States
facility: Local Institution - 0030
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0008
state: Florida
city: Maywood
country: United States
facility: Local Institution - 0168
state: Illinois
city: Fort Wayne
country: United States
facility: Local Institution - 0094
state: Indiana
city: New Orleans
country: United States
facility: Local Institution - 0171
state: Louisiana
city: Grand Rapids
country: United States
facility: Local Institution - 0173
state: Michigan
city: Burnsville
country: United States
facility: Local Institution - 0051
state: Minnesota
city: Rochester
country: United States
facility: Local Institution - 0004
state: Minnesota
city: Omaha
country: United States
facility: Local Institution - 0003
state: Nebraska
city: Las Vegas
country: United States
facility: Local Institution - 0177
state: Nevada
city: Albany
country: United States
facility: Local Institution - 0176
state: New York
city: Buffalo
country: United States
facility: Local Institution - 0157
state: New York
city: Mineola
country: United States
facility: Local Institution - 0007
state: New York
city: New York
country: United States
facility: Local Institution - 0001
state: New York
city: New York
country: United States
facility: Local Institution - 0006
state: New York
city: Chapel Hill
country: United States
facility: Local Institution - 0166
state: North Carolina
city: Durham
country: United States
facility: Local Institution
state: North Carolina
city: Portland
country: United States
facility: Local Institution - 0044
state: Oregon
city: Portland
country: United States
facility: Local Institution - 0010
state: Oregon
city: Tigard
country: United States
facility: Local Institution - 0180
state: Oregon
city: Allentown
country: United States
facility: Local Institution - 0074
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0011
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0040
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Local Institution - 0169
state: South Carolina
city: Chattanooga
country: United States
facility: Local Institution - 0009
state: Tennessee
city: Norfolk
country: United States
facility: Local Institution - 0234
state: Virginia
city: Berazategui
country: Argentina
facility: Local Institution - 0021
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution - 0090
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aire
country: Argentina
facility: Local Institution - 0089
state: Buenos Aires
city: Ciudad Autónoma de BuenosAires
country: Argentina
facility: Local Institution - 0022
state: Buenos Aires
city: Viedma
country: Argentina
facility: Local Institution - 0102
state: RIO Negro
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution - 0020
state: Tucuman
city: Liverpool
country: Australia
facility: Local Institution - 0048
state: New South Wales
city: St. Leonards
country: Australia
facility: Local Institution - 0047
state: New South Wales
city: Waratah
country: Australia
facility: Local Institution - 0046
state: New South Wales
city: Elizabeth Vale
country: Australia
facility: Local Institution - 0050
state: South Australia
city: Frankston
country: Australia
facility: Local Institution - 0184
state: Victoria
city: Perth
country: Australia
facility: Local Institution - 0175
state: Western Australia
city: Linz
country: Austria
facility: Local Institution - 0133
city: Salzburg
country: Austria
facility: Local Institution - 0136
city: Vienna
country: Austria
facility: Local Institution - 0132
city: Wien
country: Austria
facility: Local Institution - 0183
city: Hasselt
country: Belgium
facility: Local Institution - 0029
city: Liege
country: Belgium
facility: Local Institution - 0027
city: Ijui
country: Brazil
facility: Local Institution - 0071
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0072
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0070
state: Sao Paulo
city: Cerqueira Cesar
country: Brazil
facility: Local Institution - 0073
state: SAO Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution - 0231
city: São Paulo
country: Brazil
facility: Local Institution - 0100
city: Edmonton
country: Canada
facility: Local Institution - 0139
state: Alberta
city: Montreal
country: Canada
facility: Local Institution - 0109
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution - 0112
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0101
city: Santiago
country: Chile
facility: Local Institution - 0099
state: Metropolitana
city: Vina Del Mar
country: Chile
facility: Local Institution - 0038
state: Valparaiso
city: Temuco
country: Chile
facility: Local Institution - 0137
city: Beijing
country: China
facility: Local Institution - 0191
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0206
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0192
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0210
state: Chongqing
city: Fuzhou
country: China
facility: Local Institution - 0198
state: Fujian
city: Guangzhou
country: China
facility: Local Institution - 0222
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0203
state: Guangdong
city: Nanning
country: China
facility: Local Institution - 0227
state: Guangxi
city: Wuhan
country: China
facility: Local Institution - 0196
state: Hubei
city: Nanjing
country: China
facility: Local Institution - 0220
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution - 0204
state: Jiangsu
city: Nanchang
country: China
facility: Local Institution - 0223
state: Jiangxi
city: Xi'an
country: China
facility: Local Institution
state: Shan3xi
city: Yantai
country: China
facility: Local Institution - 0212
state: Shandong
city: Shanghai
country: China
facility: Local Institution - 0193
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0202
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0199
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0217
state: Shanghai
city: Chengdu
country: China
facility: Local Institution - 0229
state: Sichuan
city: Chengdu
country: China
facility: Local Institution - 0219
state: Sichuan
city: Hangzhou
country: China
facility: Local Institution - 0221
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0195
state: Zhejiang
city: Wenzhou
country: China
facility: Local Institution - 0230
state: Zhejiang
city: Bogota
country: Colombia
facility: Local Institution - 0092
city: Floridablanca
country: Colombia
facility: Local Institution - 0093
city: Medellin
country: Colombia
facility: Local Institution - 0091
city: Aalborg
country: Denmark
facility: Local Institution - 0108
city: Aarhus N
country: Denmark
facility: Local Institution - 0106
city: Copenhagen
country: Denmark
facility: Local Institution - 0107
city: Clermont-ferrand
country: France
facility: Local Institution - 0233
city: La Roche-sur-Yon
country: France
facility: Local Institution - 0115
city: Marseille Cedex 9
country: France
facility: Local Institution - 0080
city: Paris
country: France
facility: Local Institution - 0081
city: Strasbourg
country: France
facility: Local Institution - 0113
city: Suresnes
country: France
facility: Local Institution - 0097
city: Villejuif
country: France
facility: Local Institution - 0098
city: Chemnitz
country: Germany
facility: Local Institution - 0131
city: Essen
country: Germany
facility: Local Institution - 0125
city: Greifswald
country: Germany
facility: Local Institution - 0127
city: Hamburg
country: Germany
facility: Local Institution - 0126
city: Heidelberg
country: Germany
facility: Local Institution - 0124
city: Jena
country: Germany
facility: Local Institution - 0123
city: Marburg
country: Germany
facility: Local Institution - 0188
city: Muenster
country: Germany
facility: Local Institution - 0128
city: Munich
country: Germany
facility: Local Institution - 0122
city: Nuernberg
country: Germany
facility: Local Institution - 0185
city: Regensburg
country: Germany
facility: Local Institution - 0130
city: Stuttgart
country: Germany
facility: Local Institution - 0129
city: Athens
country: Greece
facility: Local Institution - 0110
city: Thessaloniki
country: Greece
facility: Local Institution - 0111
city: Wilton
country: Ireland
facility: Local Institution - 0054
state: Cork
city: Dublin
country: Ireland
facility: Local Institution - 0052
city: Haifa
country: Israel
facility: Local Institution - 0118
city: Jerusalem
country: Israel
facility: Local Institution - 0121
city: Ramat Gan
country: Israel
facility: Local Institution - 0120
city: Zerifin
country: Israel
facility: Local Institution - 0119
city: Arezzo
country: Italy
facility: Local Institution - 0088
city: Bergamo
country: Italy
facility: Local Institution - 0197
city: Milano
country: Italy
facility: Local Institution - 0082
city: Pisa
country: Italy
facility: Local Institution - 0084
city: Reggio Emilia
country: Italy
facility: Local Institution - 0189
city: Roma
country: Italy
facility: Local Institution - 0085
city: Roma
country: Italy
facility: Local Institution - 0086
city: Siena
country: Italy
facility: Local Institution - 0083
city: Akita-shi
country: Japan
facility: Local Institution - 0142
state: Akita
city: Hirosaki
country: Japan
facility: Local Institution - 0144
state: Aomori
city: Fukuoka-shi
country: Japan
facility: Local Institution - 0162
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Local Institution - 0161
state: Hokkaido
city: Sapporo
country: Japan
facility: Local Institution - 0160
state: Hokkaido
city: Tsukuba-shi
country: Japan
facility: Local Institution - 0148
state: Ibaraki
city: Nagasaki-shi
country: Japan
facility: Local Institution - 0163
state: Nagasaki
city: Niigata-shi
country: Japan
facility: Local Institution - 0150
state: Niigata
city: Okayama-city
country: Japan
facility: Local Institution - 0141
state: Okayama
city: Osakasayama
country: Japan
facility: Local Institution - 0149
state: Osaka
city: Hamamatasu
country: Japan
facility: Local Institution - 0151
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0146
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution - 0145
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0147
state: Tokyo
city: Chiba
country: Japan
facility: Local Institution - 0143
city: Osaka
country: Japan
facility: Local Institution - 0164
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0155
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0154
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0152
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0156
city: Df
country: Mexico
facility: Local Institution - 0138
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Local Institution - 0034
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 0116
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 0039
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution - 0035
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0032
state: Nuevo Leon
city: Amsterdam
country: Netherlands
facility: Local Institution - 0069
city: Maastrict
country: Netherlands
facility: Local Institution - 0068
city: Nijmegen
country: Netherlands
facility: Local Institution - 0041
city: Lima
country: Peru
facility: Local Institution - 0043
city: Gdansk
country: Poland
facility: Local Institution - 0055
city: Lodz
country: Poland
facility: Local Institution - 0057
city: Warsaw
country: Poland
facility: Local Institution - 0187
city: Wroclaw
country: Poland
facility: Local Institution - 0058
city: Wroclaw
country: Poland
facility: Local Institution - 0186
city: Bucuresti
country: Romania
facility: Local Institution - 0182
city: Craiova
country: Romania
facility: Local Institution - 0096
city: Floresti
country: Romania
facility: Local Institution - 0078
city: Timisoara, Timis
country: Romania
facility: Local Institution - 0181
city: Moscow
country: Russian Federation
facility: Local Institution - 0140
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution - 0031
city: Badalona-barcelona
country: Spain
facility: Local Institution - 0067
city: Barcelona
country: Spain
facility: Local Institution - 0066
city: Madrid
country: Spain
facility: Local Institution - 0064
city: Madrid
country: Spain
facility: Local Institution - 0062
city: Madrid
country: Spain
facility: Local Institution - 0063
city: Santander
country: Spain
facility: Local Institution - 0232
city: Sevilla
country: Spain
facility: Local Institution - 0065
city: Lund
country: Sweden
facility: Local Institution - 0105
city: Basel
country: Switzerland
facility: Local Institution - 0134
city: Zuerich
country: Switzerland
facility: Local Institution - 0135
city: Kaohsiung
country: Taiwan
facility: Local Institution - 0158
city: Taichung
country: Taiwan
facility: Local Institution - 0159
city: Taipei
country: Taiwan
facility: Local Institution - 0153
city: Manchester
country: United Kingdom
facility: Local Institution - 0025
state: Greater Manchester
city: Edinburgh
country: United Kingdom
facility: Local Institution - 0076
state: Midlothian
city: Sutton
country: United Kingdom
facility: Local Institution - 0024
state: Surrey
city: Sheffield
country: United Kingdom
facility: Local Institution - 0059
state: Yorkshire
city: London
country: United Kingdom
facility: Local Institution - 0036
city: London
country: United Kingdom
facility: Local Institution - 0114
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Bajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Neif Antonio J Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2021 Jun 3;384(22):2102-2114. doi: 10.1056/NEJMoa2034442.