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
NCT ID: NCT03661320
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
855 participants
INTERVENTIONAL
2018-11-06
2027-12-30
Brief Summary
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A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
NCT04209114
Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy
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Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder
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Survival Benefits of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy
Gemcitabine
Specified dose on specified days
Cisplatin
Specified dose on specified days
Arm B: Nivolumab + GC Chemotherapy
Nivolumab
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Cisplatin
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Cisplatin
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0022
Tucson, Arizona, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Local Institution - 0021
Littleton, Colorado, United States
Local Institution - 0036
Pensacola, Florida, United States
Local Institution - 0004
Tampa, Florida, United States
Local Institution - 0144
Atlanta, Georgia, United States
Local Institution - 0005
Chicago, Illinois, United States
Local Institution - 0006
Peoria, Illinois, United States
Local Institution - 0181
Columbia, Maryland, United States
Local Institution - 0009
Boston, Massachusetts, United States
Local Institution - 0166
Boston, Massachusetts, United States
Local Institution - 0209
Boston, Massachusetts, United States
Local Institution - 0025
Minneapolis, Minnesota, United States
Local Institution - 0129
Minneapolis, Minnesota, United States
Local Institution - 0183
Omaha, Nebraska, United States
Local Institution - 0001
Omaha, Nebraska, United States
Local Institution - 0024
Las Vegas, Nevada, United States
Local Institution - 0029
Albany, New York, United States
Local Institution - 0069
Lake Success, New York, United States
Local Institution - 0047
New York, New York, United States
Local Institution - 0191
Cleveland, Ohio, United States
Local Institution - 0028
Tigard, Oregon, United States
Local Institution - 0189
Charleston, South Carolina, United States
Local Institution - 0007
Nashville, Tennessee, United States
Local Institution - 0030
Austin, Texas, United States
Local Institution - 0023
Norfolk, Virginia, United States
Local Institution - 0051
Capital Federal, Buenos Aires, Argentina
Local Institution - 0049
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0151
Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina
Local Institution - 0131
Garran, Australian Capital Territory, Australia
Local Institution - 0130
Kingswood, New South Wales, Australia
Local Institution - 0157
Macquarie University, New South Wales, Australia
Local Institution - 0043
St Leonards, New South Wales, Australia
Local Institution - 0143
North Adelaide, South Australia, Australia
Local Institution - 0037
Heidelberg, Victoria, Australia
Local Institution - 0038
Murdoch, Western Australia, Australia
Local Institution - 0090
Klagenfurt, , Austria
Local Institution - 0091
Krems, , Austria
Local Institution - 0011
Linz, , Austria
Local Institution - 0012
Vienna, , Austria
Local Institution - 0060
Brussels, , Belgium
Local Institution - 0063
Ghent, , Belgium
Local Institution - 0062
Wilrijk, , Belgium
Local Institution - 0094
Fortaleza, Ceará, Brazil
Local Institution - 0099
Ipatinga, Minas Gerais, Brazil
Local Institution - 0092
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0212
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0097
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0098
Barretos, São Paulo, Brazil
Local Institution - 0095
Jaú, São Paulo, Brazil
Local Institution - 0093
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0164
Rio de Janeiro, , Brazil
Local Institution - 0214
São Paulo, , Brazil
Local Institution - 0159
Kelowna, British Columbia, Canada
Local Institution - 0182
North York, Ontario, Canada
Local Institution - 0192
Chicoutimi, Quebec, Canada
Local Institution - 0190
Montreal, Quebec, Canada
Local Institution - 0053
Santiago, Santiago Metropolitan, Chile
Local Institution - 0052
Santiago, Santiago Metropolitan, Chile
Local Institution - 0210
Santiago, Santiago Metropolitan, Chile
Local Institution - 0054
Santiago, Santiago Metropolitan, Chile
Local Institution - 0201
Colombia, Bogota D.C., Colombia
Local Institution - 0104
Bucaramanga, , Colombia
Local Institution - 0103
Montería, , Colombia
Local Institution - 0148
Helsinki, , Finland
Local Institution - 0145
Tampere, , Finland
Local Institution - 0146
Turku, , Finland
Local Institution - 0202
Brest, Finistère, France
Local Institution - 0204
Créteil, Val-de-Marne, France
Local Institution - 0205
Amiens, , France
Local Institution - 0198
Angers, , France
Local Institution - 0101
Besançon, , France
Local Institution - 0217
Bordeaux, , France
Local Institution - 0199
Clermont-Ferrand, , France
Local Institution - 0206
La Tronche, , France
Local Institution - 0075
Marseille, , France
Local Institution - 0200
Montpellier, , France
Local Institution - 0074
Nice, , France
Local Institution - 0163
Paris, , France
Local Institution - 0020
Pierre Benite Cedax, , France
Local Institution - 0188
Saint-Herblain, , France
Local Institution - 0002
Strasbourg, , France
Local Institution - 0003
Toulouse, , France
Local Institution - 0100
Mainz, Rhineland-Palatinate, Germany
Local Institution - 0078
Aachen, , Germany
Local Institution - 0015
Erfurt, , Germany
Local Institution - 0081
Essen, , Germany
Local Institution - 0086
Frankfurt am Main, , Germany
Local Institution - 0080
Göttingen, , Germany
Local Institution - 0013
Herne, , Germany
Local Institution - 0010
Jena, , Germany
Local Institution - 0084
Lübeck, , Germany
Local Institution - 0079
Magdeburg, , Germany
Local Institution - 0082
München, , Germany
Local Institution - 0016
Nuremberg, , Germany
Local Institution - 0085
Trier, , Germany
Local Institution - 0195
Athens, Attikí, Greece
Local Institution - 0031
Larissa, Thessalía, Greece
Local Institution - 0194
Chaïdári, , Greece
Local Institution - 0196
Tel Aviv, Tel Aviv, Israel
Local Institution - 0068
Beersheba, , Israel
Local Institution - 0066
Haifa, , Israel
Local Institution - 0067
Ramat Gan, , Israel
Local Institution - 0064
Bari, , Italy
Local Institution - 0193
Meldola (FC), , Italy
Local Institution - 0032
Milan, , Italy
Local Institution - 0065
Modena, , Italy
Local Institution - 0033
Padua, , Italy
Local Institution - 0034
Pisa, , Italy
Local Institution - 0035
Roma, , Italy
Local Institution - 0186
Komaki, Aichi-ken, Japan
Local Institution - 0184
Sapporo, Hokkaido, Japan
Local Institution - 0177
Sapporo, Hokkaido, Japan
Local Institution - 0185
Sapporo, Hokkaido, Japan
Local Institution - 0179
Tsukuba, Ibaraki, Japan
Local Institution - 0171
Kita-gun, Kagawa-ken, Japan
Local Institution - 0169
Yokohama, Kanagawa, Japan
Local Institution - 0168
Niigata, Niigata, Japan
Local Institution - 0173
Sayama, Osaka, Japan
Local Institution - 0175
Takatsuki, Osaka, Japan
Local Institution - 0176
Hidaka-shi, Saitama, Japan
Local Institution - 0170
Hamamatasu, Shizuoka, Japan
Local Institution - 0178
Minato-ku, Tokyo, Japan
Local Institution - 0172
Shinjuku-ku, Tokyo, Japan
Local Institution - 0174
Fukuoka, , Japan
Local Institution - 0180
Kyoto, , Japan
Local Institution - 0160
La Paz, BAJA Californa SUR, Mexico
Local Institution - 0102
Zapopan, Jalisco, Mexico
Local Institution - 0056
Monterrey, Nuevo León, Mexico
Local Institution - 0105
Colima, , Mexico
Local Institution - 0070
Amsterdam, , Netherlands
Local Institution - 0072
Groningen, , Netherlands
Local Institution - 0073
Sittard-Geleen, , Netherlands
Local Institution - 0087
Auckland, , New Zealand
Local Institution - 0089
Christchurch, , New Zealand
Local Institution - 0158
Grålum, , Norway
Local Institution - 0132
Lorenskog, , Norway
Local Institution - 0133
Oslo, , Norway
Local Institution - 0153
Lisbon, , Portugal
Local Institution - 0152
Porto, , Portugal
Local Institution - 0219
Cluj-Napoca, , Romania
Local Institution - 0076
Craiova, , Romania
Local Institution - 0058
Sector 2, , Romania
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution - 0154
Singapore, , Singapore
Local Institution - 0137
Goyang-si, Gyeonggi-do, South Korea
Local Institution - 0203
Seongnam-si, Kyǒnggi-do, South Korea
Local Institution - 0220
Busan, , South Korea
Local Institution - 0218
Daegu, , South Korea
Local Institution - 0208
Gyeongsangnam-do, , South Korea
Local Institution - 0215
Seongnam-si, , South Korea
Local Institution - 0140
Seoul, , South Korea
Local Institution - 0136
Seoul, , South Korea
Local Institution - 0211
Seoul, , South Korea
Local Institution - 0138
Seoul, , South Korea
Local Institution - 0113
Lugo, , Spain
Local Institution - 0111
Madrid, , Spain
Local Institution - 0112
Madrid, , Spain
Local Institution - 0114
Madrid, , Spain
Local Institution - 0156
Málaga, , Spain
Local Institution - 0109
Seville, , Spain
Local Institution - 0135
Kaohsiung City, , Taiwan
Local Institution - 0165
Taichung, , Taiwan
Local Institution - 0141
Taipei, , Taiwan
Local Institution - 0139
Taipei, , Taiwan
Local Institution - 0128
Chelmsford, Essex, United Kingdom
Local Institution - 0127
York, Yorkshire, United Kingdom
Local Institution - 0122
Glasgow, , United Kingdom
Local Institution - 0117
Lancaster, , United Kingdom
Local Institution - 0121
London, , United Kingdom
Local Institution - 0124
Oxford, , United Kingdom
Countries
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References
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Grivas P, Koshkin VS, Chu X, Cole S, Jain RK, Dreicer R, Cetnar JP, Sundi D, Gartrell BA, Galsky MD, Woo B, Li-Ning-Tapia E, Hahn NM, Carducci MA. PrECOG PrE0807: A Phase 1b Feasibility Trial of Neoadjuvant Nivolumab Without and with Lirilumab in Patients with Muscle-invasive Bladder Cancer Ineligible for or Refusing Cisplatin-based Neoadjuvant Chemotherapy. Eur Urol Oncol. 2024 Aug;7(4):914-922. doi: 10.1016/j.euo.2023.11.022. Epub 2023 Dec 27.
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.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2024-512158-12
Identifier Type: OTHER
Identifier Source: secondary_id
CA017-078
Identifier Type: -
Identifier Source: org_study_id
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