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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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03661320
Collaborator
Ono Pharmaceutical Co. Ltd (Industry)
861
Enrollment
194
Locations
2
Arms
74.3
Anticipated Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
861 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 6, 2018
Anticipated Primary Completion Date :
Jan 27, 2024
Anticipated Study Completion Date :
Jan 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy

Drug: Gemcitabine
Specified dose on specified days
Other Names:
  • Chemotherapy

    • Drug: Cisplatin
    Specified dose on specified days
    Other Names:
  • Chemotherapy

    		•
    Experimental: Arm B: Nivolumab + GC Chemotherapy

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo
  • BMS-936558

    • Drug: Gemcitabine
    Specified dose on specified days
    Other Names:
  • Chemotherapy

    • Drug: Cisplatin
    Specified dose on specified days
    Other Names:
  • Chemotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pathological Complete Response (pCR) rate, in all randomized participants [Approximately 43 months]

      Arm B vs. Arm A

    2. Event-Free Survival (EFS), in all randomized participants [Approximately 51 months]

      Arm B vs. Arm A

    Secondary Outcome Measures

    1. Overall Survival (OS) in all randomized participants [Approximately 60 months]

      Arm B vs. Arm A

    2. Incidence of Adverse Events (AE) in participants who received at least one treatment dose [Approximately 60 months]

    3. Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose [Approximately 60 months]

    4. Incidence of deaths in participants who received at least one treatment dose [Approximately 60 months]

    5. Incidence of laboratory abnormalities in participants who received at least one treatment dose [Approximately 60 months]

    6. pCR rate, descriptively in all concurrently randomized participants [Approximately 43 months]

      Arm C vs. Arm B and Arm A

    7. EFS, descriptively in all concurrently randomized participants [Approximately 51 months]

      Arm C vs. Arm B and Arm A

    8. OS, descriptively in all concurrently randomized participants [Approximately 60 months]

      Arm C vs. Arm B and Arm A

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Mobile Alabama United States 36608
    2 Local Institution Chandler Arizona United States 85224
    3 Arizona Oncology Associates Tucson Arizona United States 85711
    4 Local Institution La Jolla California United States 92093-0698
    5 Uc Irvine Health Orange California United States 92868
    6 UC Davis Comprehensive Cancer Center Sacramento California United States 95817
    7 Local Institution San Jose California United States 95124
    8 Rocky Mountain Cancer Centers Llp Littleton Colorado United States 80120-4413
    9 Local Institution New Haven Connecticut United States 06520
    10 Local Institution Newark Delaware United States 19713
    11 Woodlands Medical Specialists, Pa Pensacola Florida United States 32503
    12 Local Institution - 0004 Tampa Florida United States 33612
    13 Northside Hospital Atlanta Georgia United States 30342
    14 University of Chicago Medical Center Chicago Illinois United States 60637
    15 Illinois Cancer Care Peoria Illinois United States 61615
    16 Local Institution Baltimore Maryland United States 21201
    17 Maryland Oncology Hematology, P.A. Columbia Maryland United States 21044
    18 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    19 Cancer Center At Milford Regional Medical Center Boston Massachusetts United States 02215
    20 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    21 Minnesota Oncology Hematology Minneapolis Minnesota United States 55404
    22 Local Institution - 0129 Minneapolis Minnesota United States 55455
    23 Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha Nebraska United States 68130
    24 University Of Nebraska Medical Center Omaha Nebraska United States 68198-6840
    25 Comprehensive Cancer Centers Of Nevada Las Vegas Nevada United States 89169
    26 Local Institution Camden New Jersey United States 08103
    27 New York Oncology Hematology, Pc Albany New York United States 12208
    28 Local Institution - 0069 Lake Success New York United States 11042
    29 Columbia University Medical Center (Cumc) New York New York United States 10032
    30 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    31 Northwest Cancer Specialists, Pc Tigard Oregon United States 97223
    32 Medical University Of South Carolina Charleston South Carolina United States 29425
    33 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    34 Texas Oncology-Central Austin Cancer Center Austin Texas United States 78731
    35 Local Institution Dallas Texas United States 75390
    36 Local Institution Fort Sam Houston Texas United States 78234
    37 Virginia Oncology Associates Norfolk Virginia United States 23502
    38 Local Institution - 0051 Capital Federal Buenos Aires Argentina 1426
    39 Local Institution - 0049 Ciudad Autónoma de Buenos Aires Buenos Aires Argentina 1280
    40 Local Institution - 0151 Ciudad Autonoma Buenos Aires Distrito Federal Argentina 1118
    41 Local Institution - 0131 Garran Australian Capital Territory Australia 2605
    42 Local Institution - 0130 Kingswood New South Wales Australia 2747
    43 Local Institution - 0157 Macquarie University New South Wales Australia 2109
    44 Local Institution - 0043 St Leonards New South Wales Australia 2065
    45 Local Institution - 0143 North Adelaide South Australia Australia 5006
    46 Local Institution - 0037 Heidelberg Victoria Australia 3084
    47 Local Institution - 0038 Murdoch Western Australia Australia 6150
    48 Local Institution - 0090 Klagenfurt Am Woerthersee Austria 9020
    49 Local Institution - 0091 Krems Austria 3500
    50 Local Institution - 0011 Linz Austria 4010
    51 Local Institution - 0012 Wien Austria 1090
    52 Local Institution - 0060 Bruxelles Belgium 1200
    53 Local Institution - 0063 Gent Belgium 9000
    54 Local Institution Leuven Belgium B-300
    55 Local Institution - 0062 Wilrijk Belgium 2610
    56 Local Institution - 0094 Fortaleza Ceara Brazil 60130-241
    57 Local Institution - 0099 Ipatinga Minas Gerais Brazil 35160-158
    58 Local Institution - 0092 Ijui RIO Grande DO SUL Brazil 98700-000
    59 Local Institution - 0212 Porto Alegre RIO Grande DO SUL Brazil 90035-001
    60 Local Institution - 0097 Porto Alegre RIO Grande DO SUL Brazil 90610000
    61 Local Institution - 0098 Barretos Sao Paulo Brazil 14780-070
    62 Local Institution - 0095 Jau Sao Paulo Brazil 17210-080
    63 Local Institution - 0093 Sao Jose Do Rio Preto Sao Paulo Brazil 15090-000
    64 Local Institution - 0164 Rio De Janeiro Brazil 20231-050
    65 Instituto do Cancer Arnaldo Vieira de Carvalho Sao Paulo Brazil 01221-020
    66 Local Institution Sao Paulo Brazil 01246-000
    67 Local Institution Abbotsford British Columbia Canada V2S 0C2
    68 Local Institution - 0159 Kelowna British Columbia Canada V1Y 5L3
    69 Local Institution - 0182 North York Ontario Canada M2K 1E1
    70 Local Institution - 0192 Chicoutimi Quebec Canada G7H 5H6
    71 Local Institution - 0190 Montreal Quebec Canada H3T 1M5
    72 Local Institution - 0053 Santiago Metropolitana Chile 8330024
    73 Local Institution - 0052 Santiago Metropolitana Chile 8380456
    74 Local Institution - 0210 Santiago Metropolitana Chile 8420383
    75 Local Institution - 0054 Santiago Metropolitana Chile
    76 Local Institution - 0201 Colombia Bogota Colombia 0
    77 Local Institution - 0104 Bucaramanga Colombia 681004
    78 Local Institution - 0103 Monteria Colombia 230003
    79 Local Institution ?lborg Denmark 9000
    80 Local Institution Arhus Denmark 8000
    81 Local Institution Herlev Denmark 2730
    82 Local Institution - 0148 Helsinki Finland 00029
    83 Local Institution - 0145 Tampere Finland 33521
    84 Local Institution - 0146 Turku Finland 20251
    85 Local Institution - 0202 Brest Cedex France 29609
    86 Local Institution - 0204 Créteil Val-de-Marne France 94010
    87 Local Institution - 0205 Amiens France 80054
    88 Local Institution - 0198 Angers France 49100
    89 Local Institution - 0101 Besancon Cedex France 25030
    90 Local Institution Bordeaux France 33075
    91 Local Institution - 0217 Bordeaux France 33076
    92 Local Institution - 0199 Clermont-ferrand France 63000
    93 Local Institution - 0206 La Tronche France 38043
    94 Local Institution - 0075 Marseille France 13273
    95 Local Institution - 0200 Montpellier Cedex 5 France 34298
    96 Local Institution - 0074 Nice France 06189
    97 Local Institution - 0163 Paris France 75014
    98 Local Institution - 0020 Pierre Benite Cedax France 69495
    99 Local Institution Rennes Cedex France 35042
    100 Local Institution - 0188 Saint Herblain Cedex France 44805
    101 Local Institution - 0002 Strasbourg Cedex France 67091
    102 Local Institution - 0003 TOULOUSE Cedex 9 France 31059
    103 Local Institution - 0078 Aachen Germany 52074
    104 Local Institution - 0015 Erfurt Germany 99028
    105 Local Institution - 0081 Essen Germany 45136
    106 Local Institution - 0086 Frankfurt Main Germany 60590
    107 Local Institution - 0080 Goettingen Germany 37075
    108 Local Institution Heidelberg Germany 69120
    109 Local Institution - 0013 Herne Germany 44625
    110 Local Institution - 0010 Jena Germany 07747
    111 Local Institution - 0084 Luebeck Germany 23538
    112 Local Institution - 0079 Magdeburg Germany 39120
    113 Local Institution - 0100 Mainz Germany 55101
    114 Local Institution - 0082 Muenchen Germany 81675
    115 Local Institution - 0016 Nuernberg Germany 90419
    116 Local Institution - 0085 Trier Germany 54292
    117 Local Institution - 0031 Larissa Thessalía Greece 411 10
    118 Local Institution Athens Greece 11528
    119 Local Institution - 0194 Chaidari Greece 12462
    120 Local Institution - 0195 Holargos Greece 15562
    121 Local Institution - 0196 Tel Aviv Tel-Aviv Israel 6423906
    122 Local Institution - 0068 Beer Sheva Israel 84101
    123 Local Institution - 0066 Haifa Israel 3109601
    124 Local Institution - 0067 Ramat Gan Israel 52621
    125 Local Institution - 0064 Bari Italy 70124
    126 Local Institution - 0193 Forlì Italy 47014
    127 Local Institution - 0032 Milano Italy 20133
    128 Local Institution - 0065 Modena Italy 41012
    129 Local Institution - 0033 Padova Italy 35128
    130 Local Institution - 0034 Pisa Italy 56126
    131 Local Institution - 0035 Roma Italy 00168
    132 Local Institution - 0186 Komaki Aichi Japan 485-8520
    133 Local Institution - 0184 Sapporo Hokkaido Japan 0030804
    134 Local Institution - 0177 Sapporo Hokkaido Japan 060-8543
    135 Local Institution - 0185 Sapporo Hokkaido Japan 0608604
    136 Local Institution - 0179 Tsukuba-shi Ibaraki Japan 3058576
    137 Local Institution - 0171 Kita-gun Kagawa Japan 761-0793
    138 Local Institution - 0169 Yokohama Kanagawa Japan 222-0036
    139 Local Institution - 0168 Niigata-shi Niigata Japan 9518520
    140 Local Institution - 0173 Osakasayama Osaka Japan 589-8511
    141 Local Institution - 0175 Takatsuki City Osaka Japan 5698686
    142 Local Institution - 0176 Hidaka-shi Saitama Japan 3501298
    143 Local Institution - 0170 Hamamatsu-shi Shizuoka Japan 4313192
    144 Local Institution - 0178 Minato-ku Tokyo Japan 1058470
    145 Local Institution - 0172 Shinjuku-ku Tokyo Japan 160-8582
    146 Local Institution - 0174 Fukuoka Japan 812-8582
    147 Local Institution - 0180 Kyoto Japan 606-8507
    148 Local Institution - 0137 Goyang-si Gyeonggi-do Korea, Republic of 10408
    149 Local Institution - 0203 Seongnam-si Gyeonggi-do Korea, Republic of 13620
    150 Local Institution - 0220 Busan Korea, Republic of 48108
    151 Local Institution - 0218 Daegu Korea, Republic of 41404
    152 Local Institution - 0208 Gyeongsangnam-do Korea, Republic of 50612
    153 Local Institution - 0215 Seongnam-si, Korea, Republic of 13496
    154 Local Institution - 0140 Seoul Korea, Republic of 02841
    155 Local Institution - 0136 Seoul Korea, Republic of 03080
    156 Local Institution - 0211 Seoul Korea, Republic of 05505
    157 Local Institution - 0138 Seoul Korea, Republic of 06351
    158 Local Institution - 0160 La Paz BAJA Californa SUR Mexico 23040
    159 Local Institution Df Distrito Federal Mexico 06720
    160 Local Institution - 0102 Zapopan Jalisco Mexico 45050
    161 Local Institution - 0056 Monterrey Nuevo LEON Mexico 64460
    162 Local Institution - 0105 Colima Mexico 28017
    163 Local Institution - 0070 Amsterdam Netherlands 1066 CX
    164 Local Institution - 0072 Groningen Netherlands 9713 GZ
    165 Local Institution - 0073 Sittard-Geleen Netherlands 6162 BG
    166 Local Institution - 0087 Auckland New Zealand 1023
    167 Local Institution - 0089 Christchurch New Zealand 8011
    168 Local Institution - 0158 Gralum Norway 1714
    169 Local Institution - 0132 Lorenskog Norway 1478
    170 Local Institution - 0133 Oslo Norway 0379
    171 Local Institution - 0153 Lisboa Portugal 1649-035
    172 Local Institution Porto Portugal 4200-072
    173 Local Institution - 0219 Cluj-Napoca Romania 400015
    174 Local Institution - 0076 Craiova Romania 200347
    175 Local Institution - 0058 Sector 2 Romania 022328
    176 Local Institution Saint-Petersburg Russian Federation 194044
    177 Local Institution St Petersburg Russian Federation 197758
    178 Local Institution - 0154 Singapore Singapore 169610
    179 Local Institution - 0113 Lugo Spain 27003
    180 Local Institution - 0111 Madrid Spain 28007
    181 Local Institution - 0112 Madrid Spain 28033
    182 Local Institution - 0114 Madrid Spain 28041
    183 Local Institution - 0156 Malaga Spain 29010
    184 Local Institution - 0109 Sevilla Spain 41013
    185 Local Institution - 0135 Kaohsiung Taiwan 833401
    186 Local Institution - 0165 Taichung Taiwan 407219
    187 Local Institution - 0141 Taipei City Taiwan 100229
    188 Local Institution - 0139 Taipei Taiwan 11217
    189 Local Institution - 0128 Chelmsford Essex United Kingdom CM1 7ET
    190 Local Institution - 0127 York Yorkshire United Kingdom YO31 8HE
    191 Local Institution - 0122 Glasgow United Kingdom G12 0YN
    192 Local Institution - 0117 Lancaster United Kingdom LA1 4RP
    193 Local Institution - 0121 London United Kingdom SE1 9RT
    194 Local Institution - 0124 Oxford United Kingdom OX3 7LE

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Ono Pharmaceutical Co. Ltd

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03661320
    Other Study ID Numbers:
    • CA017-078
    • 2017-004692-31
    First Posted:
    Sep 7, 2018
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms
    Gemcitabine
    Nivolumab

    Study Results

    No Results Posted as of Jun 30, 2022