Trial 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
NCT ID:
NCT03036098
Condition:
Urothelial Cancer
Conditions: Official terms:
Carboplatin
Gemcitabine
Nivolumab
Ipilimumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Nivolumab
Description:
Specified Dose on Specified Days
Arm group label:
Arm A: Investigational immunotherapy
Arm group label:
Arm C: Investigational immunotherapy
Other name:
BMS-936558
Other name:
Opdivo
Intervention type:
Biological
Intervention name:
Ipilimumab
Description:
Specified Dose on Specified Days
Arm group label:
Arm A: Investigational immunotherapy
Other name:
BMS-734016
Other name:
Yervoy
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Specified Dose on Specified Days
Arm group label:
Arm B: Standard of care chemotherapy
Arm group label:
Arm C: Investigational immunotherapy
Arm group label:
Arm D: Standard of care chemotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Specified Dose on Specified Days
Arm group label:
Arm B: Standard of care chemotherapy
Arm group label:
Arm C: Investigational immunotherapy
Arm group label:
Arm D: Standard of care chemotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Specified Dose on Specified Days
Arm group label:
Arm B: Standard of care chemotherapy
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.
Criteria for eligibility:
Criteria:
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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Local Institution - 0001
Address:
City:
Anchorage
Zip:
99503
Country:
United States
Facility:
Name:
Local Institution - 0115
Address:
City:
Fresno
Zip:
93703
Country:
United States
Facility:
Name:
St Joseph Heritage Healthcare
Address:
City:
Santa Rosa
Zip:
95403
Country:
United States
Facility:
Name:
Local Institution - 0051
Address:
City:
Boca Raton
Zip:
33486
Country:
United States
Facility:
Name:
Local Institution - 0087
Address:
City:
Fort Lauderdale
Zip:
33308
Country:
United States
Facility:
Name:
Local Institution - 0062
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Facility:
Name:
Local Institution - 0004
Address:
City:
Athens
Zip:
30607
Country:
United States
Facility:
Name:
Local Institution - 0033
Address:
City:
Thomasville
Zip:
31792
Country:
United States
Facility:
Name:
Local Institution - 0046
Address:
City:
Chicago
Zip:
60612
Country:
United States
Facility:
Name:
Local Institution - 0117
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Facility:
Name:
Local Institution - 0056
Address:
City:
Boston
Zip:
02210
Country:
United States
Facility:
Name:
Local Institution - 0073
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Local Institution - 0208
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Local Institution - 0207
Address:
City:
Milford
Zip:
01757
Country:
United States
Facility:
Name:
Local Institution - 0063
Address:
City:
Ann Arbor
Zip:
48197
Country:
United States
Facility:
Name:
Local Institution - 0002
Address:
City:
Burnsville
Zip:
55337
Country:
United States
Facility:
Name:
Hattiesburg Clinic
Address:
City:
Hattiesburg
Zip:
39401
Country:
United States
Facility:
Name:
Local Institution - 0032
Address:
City:
Kansas City
Zip:
64111-3220
Country:
United States
Facility:
Name:
Local Institution - 0095
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
Local Institution - 0057
Address:
City:
Manchester
Zip:
03103
Country:
United States
Facility:
Name:
Local Institution - 0084
Address:
City:
Albuquerque
Zip:
87131
Country:
United States
Facility:
Name:
Local Institution - 0083
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Facility:
Name:
Local Institution - 0014
Address:
City:
Mineola
Zip:
11501
Country:
United States
Facility:
Name:
Local Institution - 0072
Address:
City:
New York
Zip:
10029
Country:
United States
Facility:
Name:
Local Institution - 0116
Address:
City:
Durham
Zip:
27710
Country:
United States
Facility:
Name:
Local Institution - 0082
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
Local Institution - 0104
Address:
City:
Portland
Zip:
97213
Country:
United States
Facility:
Name:
Local Institution - 0013
Address:
City:
Pittsburgh
Zip:
15212
Country:
United States
Facility:
Name:
Local Institution - 0086
Address:
City:
Kirkland
Zip:
98034
Country:
United States
Facility:
Name:
Local Institution - 0005
Address:
City:
Capital Federal
Zip:
1426
Country:
Argentina
Facility:
Name:
Local Institution - 0007
Address:
City:
Mar Del Plata
Zip:
7600
Country:
Argentina
Facility:
Name:
Local Institution - 0008
Address:
City:
Viedma
Zip:
8500
Country:
Argentina
Facility:
Name:
Local Institution - 0009
Address:
City:
Buenos Aires
Zip:
1120
Country:
Argentina
Facility:
Name:
Local Institution - 0134
Address:
City:
Cordoba
Zip:
5000
Country:
Argentina
Facility:
Name:
Local Institution - 0006
Address:
City:
Cordoba
Zip:
5004
Country:
Argentina
Facility:
Name:
Local Institution - 0096
Address:
City:
Waratah
Zip:
2298
Country:
Australia
Facility:
Name:
Local Institution - 0099
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Facility:
Name:
Local Institution - 0188
Address:
City:
South Brisbane
Zip:
4101
Country:
Australia
Facility:
Name:
Local Institution - 0120
Address:
City:
Tugun
Zip:
4224
Country:
Australia
Facility:
Name:
Local Institution - 0101
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Facility:
Name:
Local Institution - 0100
Address:
City:
Doubleview
Zip:
6018
Country:
Australia
Facility:
Name:
Local Institution - 0017
Address:
City:
Brasilia
Zip:
70200-730
Country:
Brazil
Facility:
Name:
Local Institution - 0021
Address:
City:
Ijui
Zip:
98700-000
Country:
Brazil
Facility:
Name:
Local Institution - 0119
Address:
City:
Passo Fundo
Zip:
99010-080
Country:
Brazil
Facility:
Name:
Local Institution - 0020
Address:
City:
Porto Alegre
Zip:
90610000
Country:
Brazil
Facility:
Name:
Local Institution - 0016
Address:
City:
Florianopolis
Zip:
88034-000
Country:
Brazil
Facility:
Name:
Local Institution - 0018
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Facility:
Name:
Local Institution - 0019
Address:
City:
Sao Jose Do Rio Preto
Zip:
15090-000
Country:
Brazil
Facility:
Name:
Local Institution - 0053
Address:
City:
Halifax
Zip:
B3H 2Y9
Country:
Canada
Facility:
Name:
Local Institution - 0064
Address:
City:
London
Zip:
N6A 4L6
Country:
Canada
Facility:
Name:
Local Institution - 0054
Address:
City:
Quebec City
Zip:
G1J 1Z4
Country:
Canada
Facility:
Name:
Local Institution - 0052
Address:
City:
Sherbrooke
Zip:
J1H 5N4
Country:
Canada
Facility:
Name:
Local Institution - 0010
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Facility:
Name:
Local Institution - 0012
Address:
City:
Vina del Mar
Zip:
2520598
Country:
Chile
Facility:
Name:
Local Institution - 0106
Address:
City:
Vitacura
Zip:
0
Country:
Chile
Facility:
Name:
Local Institution - 0171
Address:
City:
Beijing
Zip:
100001
Country:
China
Facility:
Name:
Local Institution - 0169
Address:
City:
Beijing
Zip:
100034
Country:
China
Facility:
Name:
Local Institution - 0182
Address:
City:
Chongqing
Zip:
400030
Country:
China
Facility:
Name:
Local Institution - 0217
Address:
City:
Guiyang
Zip:
550002
Country:
China
Facility:
Name:
Local Institution - 0219
Address:
City:
Harbin
Zip:
150000
Country:
China
Facility:
Name:
Local Institution - 0180
Address:
City:
Wuhan
Zip:
430030
Country:
China
Facility:
Name:
Local Institution - 0177
Address:
City:
Nanjing
Zip:
210000
Country:
China
Facility:
Name:
Local Institution - 0176
Address:
City:
Nanjing
Zip:
210008
Country:
China
Facility:
Name:
Local Institution - 0175
Address:
City:
Nanjng
Zip:
0
Country:
China
Facility:
Name:
Local Institution - 0186
Address:
City:
Changchun
Zip:
130021
Country:
China
Facility:
Name:
Local Institution - 0220
Address:
City:
Taiyuan
Zip:
030001
Country:
China
Facility:
Name:
Local Institution - 0216
Address:
City:
Yantai
Zip:
264000
Country:
China
Facility:
Name:
Local Institution - 0167
Address:
City:
Shanghai
Zip:
200025
Country:
China
Facility:
Name:
Local Institution - 0162
Address:
City:
Shanghai
Zip:
200032
Country:
China
Facility:
Name:
Local Institution - 0163
Address:
City:
Shanghai
Zip:
200040
Country:
China
Facility:
Name:
Local Institution - 0184
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Local Institution - 0173
Address:
City:
Hangzhou
Zip:
0
Country:
China
Facility:
Name:
Local Institution - 0174
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Facility:
Name:
Local Institution - 0172
Address:
City:
Hangzhou
Zip:
310014
Country:
China
Facility:
Name:
Local Institution - 0170
Address:
City:
Beijing
Zip:
100083
Country:
China
Facility:
Name:
Local Institution - 0164
Address:
City:
Shanghai
Zip:
200032
Country:
China
Facility:
Name:
Local Institution - 0160
Address:
City:
Brno
Zip:
656 53
Country:
Czechia
Facility:
Name:
Local Institution - 0152
Address:
City:
Hradec Kralove
Zip:
500 05
Country:
Czechia
Facility:
Name:
Local Institution - 0190
Address:
City:
Aalborg
Zip:
9210
Country:
Denmark
Facility:
Name:
Local Institution - 0196
Address:
City:
Herlev
Zip:
2730
Country:
Denmark
Facility:
Name:
Local Institution - 0060
Address:
City:
Helsinki
Zip:
00029
Country:
Finland
Facility:
Name:
Local Institution - 0091
Address:
City:
Nîmes
Zip:
30029
Country:
France
Facility:
Name:
Local Institution - 0089
Address:
City:
Lille
Zip:
59000
Country:
France
Facility:
Name:
Local Institution - 0088
Address:
City:
Marseille Cedex 9
Zip:
13273
Country:
France
Facility:
Name:
Local Institution - 0090
Address:
City:
St Priest En Jarez
Zip:
42271
Country:
France
Facility:
Name:
Local Institution - 0092
Address:
City:
Suresnes
Zip:
92151
Country:
France
Facility:
Name:
Local Institution - 0093
Address:
City:
Tours Cedex
Zip:
37044
Country:
France
Facility:
Name:
Local Institution - 0094
Address:
City:
Villejuif
Zip:
94805
Country:
France
Facility:
Name:
Local Institution - 0036
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Facility:
Name:
Local Institution - 0048
Address:
City:
Essen
Zip:
45147
Country:
Germany
Facility:
Name:
Local Institution - 0047
Address:
City:
Freiburg
Zip:
79106
Country:
Germany
Facility:
Name:
Local Institution - 0049
Address:
City:
Hamburg
Zip:
22763
Country:
Germany
Facility:
Name:
Local Institution - 0037
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Facility:
Name:
Local Institution - 0041
Address:
City:
Jena
Zip:
07747
Country:
Germany
Facility:
Name:
Local Institution - 0213
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Facility:
Name:
Local Institution - 0038
Address:
City:
Nuernberg
Zip:
90419
Country:
Germany
Facility:
Name:
Local Institution - 0040
Address:
City:
Tuebingen
Zip:
72076
Country:
Germany
Facility:
Name:
Local Institution - 0114
Address:
City:
Weiden
Zip:
92637
Country:
Germany
Facility:
Name:
Local Institution - 0039
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Facility:
Name:
Local Institution - 0102
Address:
City:
Athens
Zip:
115 28
Country:
Greece
Facility:
Name:
Local Institution - 0103
Address:
City:
Ioannina
Zip:
455 00
Country:
Greece
Facility:
Name:
Local Institution - 0199
Address:
City:
Kfar Saba
Zip:
44281
Country:
Israel
Facility:
Name:
Local Institution - 0198
Address:
City:
Ramat Gan
Zip:
52621
Country:
Israel
Facility:
Name:
Local Institution - 0108
Address:
City:
Arezzo
Zip:
52100
Country:
Italy
Facility:
Name:
Local Institution - 0197
Address:
City:
Faenza
Zip:
48018
Country:
Italy
Facility:
Name:
Local Institution - 0111
Address:
City:
Forlì
Zip:
47014
Country:
Italy
Facility:
Name:
Local Institution - 0109
Address:
City:
Grosseto
Zip:
58100
Country:
Italy
Facility:
Name:
Local Institution - 0107
Address:
City:
Milano
Zip:
20133
Country:
Italy
Facility:
Name:
Local Institution - 0110
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Local Institution - 0136
Address:
City:
Hirosaki
Zip:
036-8563
Country:
Japan
Facility:
Name:
Local Institution - 0135
Address:
City:
Chiba-shi
Zip:
260-8717
Country:
Japan
Facility:
Name:
Local Institution - 0147
Address:
City:
Matsuyama-shi
Zip:
7910280
Country:
Japan
Facility:
Name:
Local Institution - 0140
Address:
City:
Fukuoka-shi
Zip:
8128582
Country:
Japan
Facility:
Name:
Local Institution - 0146
Address:
City:
Sapporo-city
Zip:
0608543
Country:
Japan
Facility:
Name:
Local Institution - 0150
Address:
City:
Tsukuba-shi
Zip:
3058576
Country:
Japan
Facility:
Name:
Local Institution - 0214
Address:
City:
Morioka-shi
Zip:
0208505
Country:
Japan
Facility:
Name:
Local Institution - 0137
Address:
City:
Kita-Gun
Zip:
7610793
Country:
Japan
Facility:
Name:
Local Institution - 0141
Address:
City:
Niigata-shi
Zip:
9518520
Country:
Japan
Facility:
Name:
Local Institution - 0143
Address:
City:
Okayama-shi
Zip:
7008558
Country:
Japan
Facility:
Name:
Local Institution - 0144
Address:
City:
Osaka-shi
Zip:
5418567
Country:
Japan
Facility:
Name:
Local Institution - 0139
Address:
City:
Osakasayama
Zip:
589-8511
Country:
Japan
Facility:
Name:
Local Institution - 0145
Address:
City:
Takatsuki-shi
Zip:
5698686
Country:
Japan
Facility:
Name:
Local Institution - 0201
Address:
City:
Hamamatasu
Zip:
431-3192
Country:
Japan
Facility:
Name:
Local Institution - 0149
Address:
City:
Adachi-ku
Zip:
1168567
Country:
Japan
Facility:
Name:
Local Institution - 0148
Address:
City:
Bunkyo-ku
Zip:
1138519
Country:
Japan
Facility:
Name:
Local Institution - 0142
Address:
City:
Bunkyo-ku
Zip:
1138602
Country:
Japan
Facility:
Name:
Local Institution - 0138
Address:
City:
Shinjuku-Ku
Zip:
1608582
Country:
Japan
Facility:
Name:
Local Institution - 0215
Address:
City:
Wakayama-shi
Zip:
641-8510
Country:
Japan
Facility:
Name:
Local Institution - 0200
Address:
City:
Ube City
Zip:
755-8505
Country:
Japan
Facility:
Name:
Local Institution - 0125
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Facility:
Name:
Local Institution - 0126
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Facility:
Name:
Local Institution - 0124
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Local Institution - 0151
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Local Institution - 0128
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Facility:
Name:
Local Institution - 0127
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Facility:
Name:
Local Institution - 0129
Address:
City:
Ciudad de Mexico
Zip:
06100
Country:
Mexico
Facility:
Name:
Local Institution - 0154
Address:
City:
Mexico City
Zip:
07760
Country:
Mexico
Facility:
Name:
Local Institution - 0130
Address:
City:
Tlalpan
Zip:
14080
Country:
Mexico
Facility:
Name:
Local Institution - 0131
Address:
City:
Monterrey
Zip:
64460
Country:
Mexico
Facility:
Name:
Local Institution - 0022
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Facility:
Name:
Local Institution - 0055
Address:
City:
Enschede
Zip:
7512KZ
Country:
Netherlands
Facility:
Name:
Local Institution - 0024
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Facility:
Name:
Local Institution - 0026
Address:
City:
Leeuwarden
Zip:
8934 AD
Country:
Netherlands
Facility:
Name:
Local Institution - 0074
Address:
City:
Bergen
Zip:
5021
Country:
Norway
Facility:
Name:
Local Institution - 0081
Address:
City:
Lorenskog
Zip:
1478
Country:
Norway
Facility:
Name:
Local Institution - 0030
Address:
City:
Lima
Zip:
34
Country:
Peru
Facility:
Name:
Local Institution - 0031
Address:
City:
Lima
Zip:
Lima 27
Country:
Peru
Facility:
Name:
Local Institution - 0189
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Facility:
Name:
Local Institution - 0205
Address:
City:
Koszalin
Zip:
75-581
Country:
Poland
Facility:
Name:
Local Institution - 0202
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Facility:
Name:
Local Institution - 0191
Address:
City:
Cluj-Napoca
Zip:
400015
Country:
Romania
Facility:
Name:
Local Institution - 0187
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Facility:
Name:
Local Institution
Address:
City:
Moscow
Zip:
125367
Country:
Russian Federation
Facility:
Name:
Local Institution - 0192
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Facility:
Name:
Local Institution - 0070
Address:
City:
A Coruna
Zip:
15006
Country:
Spain
Facility:
Name:
Local Institution - 0068
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Facility:
Name:
Local Institution - 0065
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Facility:
Name:
Local Institution - 0066
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Local Institution - 0209
Address:
City:
Santander
Zip:
39008
Country:
Spain
Facility:
Name:
Local Institution - 0067
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Facility:
Name:
Local Institution - 0069
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Facility:
Name:
Local Institution - 0075
Address:
City:
Jonkoping
Zip:
553 05
Country:
Sweden
Facility:
Name:
Local Institution - 0059
Address:
City:
Linkoping
Zip:
581 85
Country:
Sweden
Facility:
Name:
Local Institution - 0058
Address:
City:
Lund
Zip:
221 85
Country:
Sweden
Facility:
Name:
Local Institution - 0061
Address:
City:
Baden
Zip:
5404
Country:
Switzerland
Facility:
Name:
Local Institution - 0042
Address:
City:
Chur
Zip:
7000
Country:
Switzerland
Facility:
Name:
Local Institution - 0156
Address:
City:
Kaohsiung
Zip:
833
Country:
Taiwan
Facility:
Name:
Local Institution - 0159
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Facility:
Name:
Local Institution - 0158
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Facility:
Name:
Local Institution - 0155
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Facility:
Name:
Local Institution - 0157
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Facility:
Name:
Local Institution - 0194
Address:
City:
Ankara
Zip:
06590
Country:
Turkey
Facility:
Name:
Local Institution - 0204
Address:
City:
Istanbul
Zip:
34300
Country:
Turkey
Facility:
Name:
Local Institution - 0193
Address:
City:
Izmir
Zip:
35340
Country:
Turkey
Start date:
March 24, 2017
Completion date:
June 1, 2028
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Collaborator:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT03036098
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.BMSClinicalTrials.com
