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

April 10, 2026 updated by: Bristol-Myers Squibb

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

855

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1426
        • Local Institution - 0051
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
        • Local Institution - 0049
    • Distrito Federal
      • Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina, 1118
        • Local Institution - 0151
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Local Institution - 0131
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Local Institution - 0130
      • Macquarie University, New South Wales, Australia, 2109
        • Local Institution - 0157
      • St Leonards, New South Wales, Australia, 2065
        • Local Institution - 0043
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Local Institution - 0143
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0037
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0038
  • Austria
      • Klagenfurt, Austria, 9020
        • Local Institution - 0090
      • Krems, Austria, 3500
        • Local Institution - 0091
      • Linz, Austria, 4020
        • Local Institution - 0011
      • Vienna, Austria, 1090
        • Local Institution - 0012
  • Belgium
      • Brussels, Belgium, 1200
        • Local Institution - 0060
      • Ghent, Belgium, 9000
        • Local Institution - 0063
      • Wilrijk, Belgium, 2610
        • Local Institution - 0062
  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Local Institution - 0164
      • São Paulo, Brazil, 01221-020
        • Local Institution - 0214
    • Ceará
      • Fortaleza, Ceará, Brazil, 60130-241
        • Local Institution - 0094
    • Minas Gerais
      • Ipatinga, Minas Gerais, Brazil, 35160-158
        • Local Institution - 0099
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Local Institution - 0092
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Local Institution - 0212
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610000
        • Local Institution - 0097
    • São Paulo
      • Barretos, São Paulo, Brazil, 14780-070
        • Local Institution - 0098
      • Jaú, São Paulo, Brazil, 17210-080
        • Local Institution - 0095
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Local Institution - 0093
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Local Institution - 0159
    • Ontario
      • North York, Ontario, Canada, M2K 1E1
        • Local Institution - 0182
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Local Institution - 0192
      • Montreal, Quebec, Canada, H3T 1M5
        • Local Institution - 0190
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8330024
        • Local Institution - 0053
      • Santiago, Santiago Metropolitan, Chile, 8380456
        • Local Institution - 0052
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0210
      • Santiago, Santiago Metropolitan, Chile
        • Local Institution - 0054
  • Colombia
      • Bucaramanga, Colombia, 681004
        • Local Institution - 0104
      • Montería, Colombia, 230003
        • Local Institution - 0103
    • Bogota D.C.
      • Colombia, Bogota D.C., Colombia
        • Local Institution - 0201
  • Finland
      • Helsinki, Finland, 00029
        • Local Institution - 0148
      • Tampere, Finland, 33521
        • Local Institution - 0145
      • Turku, Finland, 20251
        • Local Institution - 0146
  • France
      • Amiens, France, 80054
        • Local Institution - 0205
      • Angers, France, 49100
        • Local Institution - 0198
      • Besançon, France, 25000
        • Local Institution - 0101
      • Bordeaux, France, 33076
        • Local Institution - 0217
      • Clermont-Ferrand, France, 63000
        • Local Institution - 0199
      • La Tronche, France, 38043
        • Local Institution - 0206
      • Marseille, France, 13273
        • Local Institution - 0075
      • Montpellier, France, 34298
        • Local Institution - 0200
      • Nice, France, 06189
        • Local Institution - 0074
      • Paris, France, 75014
        • Local Institution - 0163
      • Pierre Benite Cedax, France, 69495
        • Local Institution - 0020
      • Saint-Herblain, France, 44805
        • Local Institution - 0188
      • Strasbourg, France, 67091
        • Local Institution - 0002
      • Toulouse, France, 31059
        • Local Institution - 0003
    • Finistère
      • Brest, Finistère, France, 29609
        • Local Institution - 0202
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • Local Institution - 0204
  • Germany
      • Aachen, Germany, 52074
        • Local Institution - 0078
      • Erfurt, Germany, 99028
        • Local Institution - 0015
      • Essen, Germany, 45136
        • Local Institution - 0081
      • Frankfurt am Main, Germany, 60590
        • Local Institution - 0086
      • Göttingen, Germany, 37075
        • Local Institution - 0080
      • Herne, Germany, 44625
        • Local Institution - 0013
      • Jena, Germany, 07747
        • Local Institution - 0010
      • Lübeck, Germany, 23538
        • Local Institution - 0084
      • Magdeburg, Germany, 39120
        • Local Institution - 0079
      • München, Germany, 81675
        • Local Institution - 0082
      • Nuremberg, Germany, 90419
        • Local Institution - 0016
      • Trier, Germany, 54292
        • Local Institution - 0085
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Local Institution - 0100
  • Greece
      • Chaïdári, Greece, 12462
        • Local Institution - 0194
    • Attikí
      • Athens, Attikí, Greece, 155 62
        • Local Institution - 0195
    • Thessalía
      • Larissa, Thessalía, Greece, 411 10
        • Local Institution - 0031
  • Israel
      • Beersheba, Israel, 84101
        • Local Institution - 0068
      • Haifa, Israel, 3109601
        • Local Institution - 0066
      • Ramat Gan, Israel, 52621
        • Local Institution - 0067
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Local Institution - 0196
  • Italy
      • Bari, Italy, 70124
        • Local Institution - 0064
      • Meldola (FC), Italy, 47014
        • Local Institution - 0193
      • Milan, Italy, 20133
        • Local Institution - 0032
      • Modena, Italy, 41012
        • Local Institution - 0065
      • Padova, Italy, 35128
        • Local Institution - 0033
      • Pisa, Italy, 56126
        • Local Institution - 0034
      • Roma, Italy, 00168
        • Local Institution - 0035
  • Japan
      • Fukuoka, Japan, 812-8582
        • Local Institution - 0174
      • Kyoto, Japan, 606-8507
        • Local Institution - 0180
    • Aichi-ken
      • Komaki, Aichi-ken, Japan, 485-8520
        • Local Institution - 0186
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0030804
        • Local Institution - 0184
      • Sapporo, Hokkaido, Japan, 060-8543
        • Local Institution - 0177
      • Sapporo, Hokkaido, Japan, 0608604
        • Local Institution - 0185
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 3058576
        • Local Institution - 0179
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 761-0793
        • Local Institution - 0171
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 222-0036
        • Local Institution - 0169
    • Niigata
      • Niigata, Niigata, Japan, 9518520
        • Local Institution - 0168
    • Osaka
      • Sayama, Osaka, Japan, 589-8511
        • Local Institution - 0173
      • Takatsuki, Osaka, Japan, 569-8686
        • Local Institution - 0175
    • Saitama
      • Hidaka-shi, Saitama, Japan, 3501298
        • Local Institution - 0176
    • Shizuoka
      • Hamamatasu, Shizuoka, Japan, 431-3192
        • Local Institution - 0170
    • Tokyo
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution - 0178
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Local Institution - 0172
  • Mexico
      • Colima, Mexico, 28017
        • Local Institution - 0105
    • BAJA Californa SUR
      • La Paz, BAJA Californa SUR, Mexico, 23040
        • Local Institution - 0160
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45050
        • Local Institution - 0102
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Local Institution - 0056
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution - 0070
      • Groningen, Netherlands, 9713 GZ
        • Local Institution - 0072
      • Sittard-Geleen, Netherlands, 6162 BG
        • Local Institution - 0073
  • New Zealand
      • Auckland, New Zealand, 1023
        • Local Institution - 0087
      • Christchurch, New Zealand, 8011
        • Local Institution - 0089
  • Norway
      • Grålum, Norway, 1714
        • Local Institution - 0158
      • Lorenskog, Norway, 1478
        • Local Institution - 0132
      • Oslo, Norway, 0379
        • Local Institution - 0133
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Local Institution - 0153
      • Porto, Portugal, 4200-072
        • Local Institution - 0152
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0219
      • Craiova, Romania, 200542
        • Local Institution - 0076
      • Sector 2, Romania, 022328
        • Local Institution - 0058
  • Russia
      • Saint Petersburg, Russia, 197758
        • Local Institution
      • Saint Petersburg, Russia, 194044
        • Local Institution
  • Singapore
      • Singapore, Singapore, 168583
        • Local Institution - 0154
  • South Korea
      • Busan, South Korea, 48108
        • Local Institution - 0220
      • Daegu, South Korea, 41404
        • Local Institution - 0218
      • Gyeongsangnam-do, South Korea, 50612
        • Local Institution - 0208
      • Seongnam-si, South Korea, 13496
        • Local Institution - 0215
      • Seoul, South Korea, 02841
        • Local Institution - 0140
      • Seoul, South Korea, 03080
        • Local Institution - 0136
      • Seoul, South Korea, 05505
        • Local Institution - 0211
      • Seoul, South Korea, 06351
        • Local Institution - 0138
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • Local Institution - 0137
    • Kyǒnggi-do
      • Seongnam-si, Kyǒnggi-do, South Korea, 13620
        • Local Institution - 0203
  • Spain
      • Lugo, Spain, 27003
        • Local Institution - 0113
      • Madrid, Spain, 28007
        • Local Institution - 0111
      • Madrid, Spain, 28033
        • Local Institution - 0112
      • Madrid, Spain, 28041
        • Local Institution - 0114
      • Málaga, Spain, 29010
        • Local Institution - 0156
      • Seville, Spain, 41013
        • Local Institution - 0109
  • Taiwan
      • Kaohsiung City, Taiwan, 833401
        • Local Institution - 0135
      • Taichung, Taiwan, 407219
        • Local Institution - 0165
      • Taipei, Taiwan, 11217
        • Local Institution - 0139
      • Taipei, Taiwan, 100229
        • Local Institution - 0141
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Local Institution - 0122
      • Lancaster, United Kingdom, LA1 4RP
        • Local Institution - 0117
      • London, United Kingdom, SE1 9RT
        • Local Institution - 0121
      • Oxford, United Kingdom, OX3 7LE
        • Local Institution - 0124
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • Local Institution - 0128
    • Yorkshire
      • York, Yorkshire, United Kingdom, YO31 8HE
        • Local Institution - 0127
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Local Institution - 0022
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center
    • Colorado
      • Littleton, Colorado, United States, 80120-4413
        • Local Institution - 0021
    • Florida
      • Pensacola, Florida, United States, 32503
        • Local Institution - 0036
      • Tampa, Florida, United States, 33612
        • Local Institution - 0004
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 0144
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Local Institution - 0005
      • Peoria, Illinois, United States, 61615
        • Local Institution - 0006
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Local Institution - 0181
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0009
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0166
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0209
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Local Institution - 0025
      • Minneapolis, Minnesota, United States, 55455
        • Local Institution - 0129
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Local Institution - 0183
      • Omaha, Nebraska, United States, 68198-6840
        • Local Institution - 0001
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Local Institution - 0024
    • New York
      • Albany, New York, United States, 12208
        • Local Institution - 0029
      • Lake Success, New York, United States, 11042
        • Local Institution - 0069
      • New York, New York, United States, 10065
        • Local Institution - 0047
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0191
    • Oregon
      • Tigard, Oregon, United States, 97223
        • Local Institution - 0028
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution - 0189
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Local Institution - 0007
    • Texas
      • Austin, Texas, United States, 78731
        • Local Institution - 0030
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Local Institution - 0023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy
Drug: Cisplatin
Specified dose on specified days
Other Names:
  • Chemotherapy
Drug: Gemcitabine
Specified dose on specified days
Other Names:
  • Chemotherapy
Experimental: Arm B: Nivolumab + GC Chemotherapy
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Cisplatin
Specified dose on specified days
Other Names:
  • Chemotherapy
Drug: Gemcitabine
Specified dose on specified days
Other Names:
  • Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR) rate, in all randomized participants
Time Frame: Approximately 43 months
Arm B vs. Arm A
Approximately 43 months
Event-Free Survival (EFS), in all randomized participants
Time Frame: Approximately 36 months
Arm B vs. Arm A
Approximately 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in all randomized participants
Time Frame: Approximately 60 months
Arm B vs. Arm A
Approximately 60 months
Incidence of Adverse Events (AE) in participants who received at least one treatment dose
Time Frame: Approximately 60 months
Approximately 60 months
Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose
Time Frame: Approximately 60 months
Approximately 60 months
Incidence of deaths in participants who received at least one treatment dose
Time Frame: Approximately 60 months
Approximately 60 months
Incidence of laboratory abnormalities in participants who received at least one treatment dose
Time Frame: Approximately 60 months
Approximately 60 months
pCR rate, descriptively in all concurrently randomized participants
Time Frame: Approximately 43 months
Arm C vs. Arm B and Arm A
Approximately 43 months
OS, descriptively in all concurrently randomized participants
Time Frame: Approximately 60 months
Arm C vs. Arm B and Arm A
Approximately 60 months
EFS, descriptively in all concurrently randomized participants
Time Frame: Approximately 36 months
Arm C vs. Arm B and Arm A
Approximately 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2018

Primary Completion (Actual)

February 16, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA017-078
  • 2024-512158-12 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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