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A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

Primary Purpose

Urinary Bladder Neoplasms, Muscle-Invasive Bladder Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Gemcitabine
Cisplatin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion Criteria:

  • Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
  • Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted

Sites / Locations

  • Local Institution - 0022
  • UC Davis Comprehensive Cancer Center
  • Local Institution - 0021
  • Local Institution - 0036
  • Local Institution - 0004
  • Local Institution - 0144
  • Local Institution - 0005
  • Local Institution - 0006
  • Local Institution - 0181
  • Local Institution - 0009
  • Local Institution - 0166
  • Local Institution - 0209
  • Local Institution - 0025
  • Local Institution - 0129
  • Local Institution - 0183
  • Local Institution - 0001
  • Local Institution - 0024
  • Local Institution - 0029
  • Local Institution - 0069
  • Local Institution - 0047
  • Local Institution - 0191
  • Local Institution - 0028
  • Local Institution - 0189
  • Local Institution - 0007
  • Local Institution - 0030
  • Local Institution - 0023
  • Instituto Medico Especializado Alexander Fleming
  • Local Institution - 0049
  • Local Institution - 0151
  • Local Institution - 0131
  • Local Institution - 0130
  • Local Institution - 0157
  • Local Institution - 0043
  • Local Institution - 0143
  • Local Institution - 0037
  • Local Institution - 0038
  • Local Institution - 0090
  • Local Institution - 0091
  • Local Institution - 0011
  • Local Institution - 0012
  • Local Institution - 0060
  • Local Institution - 0063
  • Local Institution - 0062
  • Local Institution - 0094
  • Local Institution - 0099
  • Local Institution - 0092
  • Local Institution - 0212
  • Local Institution - 0097
  • Local Institution - 0098
  • Local Institution - 0095
  • Local Institution - 0093
  • Local Institution - 0164
  • Local Institution - 0214
  • Local Institution - 0159
  • Local Institution - 0182
  • Local Institution - 0192
  • Local Institution - 0190
  • Local Institution - 0053
  • Local Institution - 0052
  • Local Institution - 0210
  • Local Institution - 0054
  • Local Institution - 0201
  • Local Institution - 0104
  • Local Institution - 0103
  • Local Institution - 0148
  • Local Institution - 0145
  • Local Institution - 0146
  • Local Institution - 0202
  • Local Institution - 0204
  • Local Institution - 0205
  • Local Institution - 0198
  • Local Institution - 0101
  • Local Institution - 0217
  • Local Institution - 0199
  • Local Institution - 0206
  • Local Institution - 0075
  • Local Institution - 0200
  • Local Institution - 0074
  • Local Institution - 0163
  • Local Institution - 0020
  • Local Institution - 0188
  • Local Institution - 0002
  • Local Institution - 0003
  • Local Institution - 0078
  • Local Institution - 0015
  • Local Institution - 0081
  • Local Institution - 0086
  • Local Institution - 0080
  • Local Institution - 0013
  • Local Institution - 0010
  • Local Institution - 0084
  • Local Institution - 0079
  • Local Institution - 0100
  • Local Institution - 0082
  • Local Institution - 0016
  • Local Institution - 0085
  • Local Institution - 0195
  • Local Institution - 0031
  • Local Institution - 0194
  • Local Institution - 0196
  • Local Institution - 0068
  • Local Institution - 0066
  • Local Institution - 0067
  • Local Institution - 0064
  • Local Institution - 0193
  • Local Institution - 0032
  • Local Institution - 0065
  • Local Institution - 0033
  • Local Institution - 0034
  • Local Institution - 0035
  • Local Institution - 0186
  • Local Institution - 0184
  • Local Institution - 0177
  • Local Institution - 0185
  • Local Institution - 0179
  • Local Institution - 0171
  • Local Institution - 0169
  • Local Institution - 0168
  • Local Institution - 0173
  • Local Institution - 0175
  • Local Institution - 0176
  • Local Institution - 0170
  • Local Institution - 0178
  • Local Institution - 0172
  • Local Institution - 0174
  • Local Institution - 0180
  • Local Institution - 0137
  • Local Institution - 0203
  • Local Institution - 0220
  • Local Institution - 0218
  • Local Institution - 0208
  • Local Institution - 0215
  • Local Institution - 0140
  • Local Institution - 0136
  • Local Institution - 0211
  • Local Institution - 0138
  • Local Institution - 0160
  • Local Institution
  • Local Institution - 0102
  • Local Institution - 0056
  • Local Institution - 0105
  • Local Institution - 0070
  • Local Institution - 0072
  • Local Institution - 0073
  • Local Institution - 0087
  • Local Institution - 0089
  • Local Institution - 0158
  • Local Institution - 0132
  • Local Institution - 0133
  • Local Institution - 0153
  • Local Institution - 0152
  • Local Institution - 0219
  • Local Institution - 0076
  • Local Institution - 0058
  • Local Institution
  • Local Institution
  • Local Institution - 0154
  • Local Institution - 0113
  • Local Institution - 0111
  • Local Institution - 0112
  • Local Institution - 0114
  • Local Institution - 0156
  • Local Institution - 0109
  • Local Institution - 0135
  • Local Institution - 0165
  • Local Institution - 0141
  • Local Institution - 0139
  • Local Institution - 0128
  • Local Institution - 0127
  • Local Institution - 0122
  • Local Institution - 0117
  • Local Institution - 0121
  • Local Institution - 0124

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy

Arm B: Nivolumab + GC Chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Pathological Complete Response (pCR) rate, in all randomized participants
Arm B vs. Arm A
Event-Free Survival (EFS), in all randomized participants
Arm B vs. Arm A

Secondary Outcome Measures

Overall Survival (OS) in all randomized participants
Arm B vs. Arm A
Incidence of Adverse Events (AE) in participants who received at least one treatment dose
Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose
Incidence of deaths in participants who received at least one treatment dose
Incidence of laboratory abnormalities in participants who received at least one treatment dose
pCR rate, descriptively in all concurrently randomized participants
Arm C vs. Arm B and Arm A
EFS, descriptively in all concurrently randomized participants
Arm C vs. Arm B and Arm A
OS, descriptively in all concurrently randomized participants
Arm C vs. Arm B and Arm A

Full Information

First Posted
September 5, 2018
Last Updated
January 25, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03661320
Brief Title
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
Official Title
A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
November 3, 2023 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms, Muscle-Invasive Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
861 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy
Arm Type
Active Comparator
Arm Title
Arm B: Nivolumab + GC Chemotherapy
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Chemotherapy
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Chemotherapy
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Pathological Complete Response (pCR) rate, in all randomized participants
Description
Arm B vs. Arm A
Time Frame
Approximately 43 months
Title
Event-Free Survival (EFS), in all randomized participants
Description
Arm B vs. Arm A
Time Frame
Approximately 51 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in all randomized participants
Description
Arm B vs. Arm A
Time Frame
Approximately 60 months
Title
Incidence of Adverse Events (AE) in participants who received at least one treatment dose
Time Frame
Approximately 60 months
Title
Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose
Time Frame
Approximately 60 months
Title
Incidence of deaths in participants who received at least one treatment dose
Time Frame
Approximately 60 months
Title
Incidence of laboratory abnormalities in participants who received at least one treatment dose
Time Frame
Approximately 60 months
Title
pCR rate, descriptively in all concurrently randomized participants
Description
Arm C vs. Arm B and Arm A
Time Frame
Approximately 43 months
Title
EFS, descriptively in all concurrently randomized participants
Description
Arm C vs. Arm B and Arm A
Time Frame
Approximately 51 months
Title
OS, descriptively in all concurrently randomized participants
Description
Arm C vs. Arm B and Arm A
Time Frame
Approximately 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Exclusion Criteria: Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0022
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Local Institution - 0021
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120-4413
Country
United States
Facility Name
Local Institution - 0036
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Local Institution - 0004
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Local Institution - 0144
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Local Institution - 0005
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Local Institution - 0006
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Local Institution - 0181
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Local Institution - 0009
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution - 0166
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0209
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0025
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Local Institution - 0129
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Local Institution - 0183
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Local Institution - 0001
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-6840
Country
United States
Facility Name
Local Institution - 0024
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Local Institution - 0029
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Local Institution - 0069
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Local Institution - 0047
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 0191
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution - 0028
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Local Institution - 0189
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0007
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Local Institution - 0030
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Local Institution - 0023
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Instituto Medico Especializado Alexander Fleming
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0049
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Local Institution - 0151
City
Ciudad Autonoma Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1118
Country
Argentina
Facility Name
Local Institution - 0131
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Local Institution - 0130
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Local Institution - 0157
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Local Institution - 0043
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Local Institution - 0143
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Local Institution - 0037
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 0038
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution - 0090
City
Klagenfurt Am Woerthersee
ZIP/Postal Code
9020
Country
Austria
Facility Name
Local Institution - 0091
City
Krems
ZIP/Postal Code
3500
Country
Austria
Facility Name
Local Institution - 0011
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Local Institution - 0012
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0060
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution - 0063
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0062
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Local Institution - 0094
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60130-241
Country
Brazil
Facility Name
Local Institution - 0099
City
Ipatinga
State/Province
Minas Gerais
ZIP/Postal Code
35160-158
Country
Brazil
Facility Name
Local Institution - 0092
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution - 0212
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Local Institution - 0097
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90610000
Country
Brazil
Facility Name
Local Institution - 0098
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14780-070
Country
Brazil
Facility Name
Local Institution - 0095
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
Local Institution - 0093
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Local Institution - 0164
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Local Institution - 0214
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Local Institution - 0159
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Local Institution - 0182
City
North York
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada
Facility Name
Local Institution - 0192
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
Local Institution - 0190
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Facility Name
Local Institution - 0053
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8330024
Country
Chile
Facility Name
Local Institution - 0052
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Local Institution - 0210
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Local Institution - 0054
City
Santiago
State/Province
Metropolitana
Country
Chile
Facility Name
Local Institution - 0201
City
Colombia
State/Province
Bogota
ZIP/Postal Code
0
Country
Colombia
Facility Name
Local Institution - 0104
City
Bucaramanga
ZIP/Postal Code
681004
Country
Colombia
Facility Name
Local Institution - 0103
City
Monteria
ZIP/Postal Code
230003
Country
Colombia
Facility Name
Local Institution - 0148
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Local Institution - 0145
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Local Institution - 0146
City
Turku
ZIP/Postal Code
20251
Country
Finland
Facility Name
Local Institution - 0202
City
Brest
State/Province
Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Local Institution - 0204
City
Créteil
State/Province
Val-de-Marne
ZIP/Postal Code
94010
Country
France
Facility Name
Local Institution - 0205
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Local Institution - 0198
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Local Institution - 0101
City
Besancon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Local Institution - 0217
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Local Institution - 0199
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Local Institution - 0206
City
La Tronche
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution - 0075
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Local Institution - 0200
City
Montpellier Cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Local Institution - 0074
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Local Institution - 0163
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Local Institution - 0020
City
Pierre Benite Cedax
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution - 0188
City
Saint Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Local Institution - 0002
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Local Institution - 0003
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 0078
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Local Institution - 0015
City
Erfurt
ZIP/Postal Code
99028
Country
Germany
Facility Name
Local Institution - 0081
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Local Institution - 0086
City
Frankfurt Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution - 0080
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution - 0013
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Local Institution - 0010
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Local Institution - 0084
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Local Institution - 0079
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Local Institution - 0100
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Local Institution - 0082
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Local Institution - 0016
City
Nuernberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Local Institution - 0085
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Local Institution - 0195
City
Athens
State/Province
Attikí
ZIP/Postal Code
155 62
Country
Greece
Facility Name
Local Institution - 0031
City
Larissa
State/Province
Thessalía
ZIP/Postal Code
411 10
Country
Greece
Facility Name
Local Institution - 0194
City
Chaidari
ZIP/Postal Code
12462
Country
Greece
Facility Name
Local Institution - 0196
City
Tel Aviv
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Local Institution - 0068
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Local Institution - 0066
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Local Institution - 0067
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution - 0064
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Local Institution - 0193
City
Forlì
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution - 0032
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution - 0065
City
Modena
ZIP/Postal Code
41012
Country
Italy
Facility Name
Local Institution - 0033
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution - 0034
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Local Institution - 0035
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution - 0186
City
Komaki
State/Province
Aichi
ZIP/Postal Code
485-8520
Country
Japan
Facility Name
Local Institution - 0184
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
0030804
Country
Japan
Facility Name
Local Institution - 0177
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Local Institution - 0185
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
0608604
Country
Japan
Facility Name
Local Institution - 0179
City
Tsukuba-shi
State/Province
Ibaraki
ZIP/Postal Code
3058576
Country
Japan
Facility Name
Local Institution - 0171
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Local Institution - 0169
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
Local Institution - 0168
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
9518520
Country
Japan
Facility Name
Local Institution - 0173
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Local Institution - 0175
City
Takatsuki City
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Facility Name
Local Institution - 0176
City
Hidaka-shi
State/Province
Saitama
ZIP/Postal Code
3501298
Country
Japan
Facility Name
Local Institution - 0170
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
4313192
Country
Japan
Facility Name
Local Institution - 0178
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
1058470
Country
Japan
Facility Name
Local Institution - 0172
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Local Institution - 0174
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Local Institution - 0180
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Local Institution - 0137
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Local Institution - 0203
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Local Institution - 0220
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Local Institution - 0218
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Local Institution - 0208
City
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Local Institution - 0215
City
Seongnam-si,
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Local Institution - 0140
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Local Institution - 0136
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution - 0211
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution - 0138
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 0160
City
La Paz
State/Province
BAJA Californa SUR
ZIP/Postal Code
23040
Country
Mexico
Facility Name
Local Institution
City
Df
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Local Institution - 0102
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45050
Country
Mexico
Facility Name
Local Institution - 0056
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution - 0105
City
Colima
ZIP/Postal Code
28017
Country
Mexico
Facility Name
Local Institution - 0070
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Local Institution - 0072
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Local Institution - 0073
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Local Institution - 0087
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Local Institution - 0089
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Local Institution - 0158
City
Gralum
ZIP/Postal Code
1714
Country
Norway
Facility Name
Local Institution - 0132
City
Lorenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Local Institution - 0133
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Facility Name
Local Institution - 0153
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Local Institution - 0152
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Local Institution - 0219
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution - 0076
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Local Institution - 0058
City
Sector 2
ZIP/Postal Code
022328
Country
Romania
Facility Name
Local Institution
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Local Institution
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution - 0154
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Local Institution - 0113
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Local Institution - 0111
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 0112
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Local Institution - 0114
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0156
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 0109
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution - 0135
City
Kaohsiung
ZIP/Postal Code
833401
Country
Taiwan
Facility Name
Local Institution - 0165
City
Taichung
ZIP/Postal Code
407219
Country
Taiwan
Facility Name
Local Institution - 0141
City
Taipei City
ZIP/Postal Code
100229
Country
Taiwan
Facility Name
Local Institution - 0139
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Local Institution - 0128
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Local Institution - 0127
City
York
State/Province
Yorkshire
ZIP/Postal Code
YO31 8HE
Country
United Kingdom
Facility Name
Local Institution - 0122
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Local Institution - 0117
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Local Institution - 0121
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Local Institution - 0124
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31823654
Citation
Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD. ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer. Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

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