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CheckMate901: 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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03036098
Collaborator
Ono Pharmaceutical Co. Ltd (Industry)
1,307
Enrollment
197
Locations
4
Arms
99.7
Anticipated Duration (Months)
6.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1307 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer
Actual Study Start Date :
Mar 24, 2017
Anticipated Primary Completion Date :
Nov 13, 2022
Anticipated Study Completion Date :
Jul 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Investigational immunotherapy

Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • BMS-936558
  • Opdivo

    • Biological: Ipilimumab
    Specified Dose on Specified Days
    Other Names:
  • BMS-734016
  • Yervoy

    		•
    Active Comparator: Arm B: Standard of care chemotherapy

    Drug: Gemcitabine
    Specified Dose on Specified Days

    Drug: Cisplatin
    Specified Dose on Specified Days

    Drug: Carboplatin
    Specified Dose on Specified Days
    Experimental: Arm C: Investigational immunotherapy

    Biological: Nivolumab
    Specified Dose on Specified Days
    Other Names:
  • BMS-936558
  • Opdivo

    • Drug: Gemcitabine
    Specified Dose on Specified Days

    Drug: Cisplatin
    Specified Dose on Specified Days
    Active Comparator: Arm D: Standard of care chemotherapy

    Drug: Gemcitabine
    Specified Dose on Specified Days

    Drug: Cisplatin
    Specified Dose on Specified Days

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) in cisplatin-ineligible randomized participants [Up to 55 months]

    2. Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC) [Up to 52 months]

    3. Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC [Up to 64 months]

    4. Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC [Up to 64 months]

    Secondary Outcome Measures

    1. Overall survival (OS) in all randomized participants [Up to 55 months]

    2. Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants [Up to 55 months]

    3. Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PD-L1 positive (≥1%) randomized participants [Up to 55 months]

    4. Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants [Up to 55 months]

    5. European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants [Up to 55 months]

    6. European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC [Up to 64 months]

    7. Progression-free survival (PFS) by BICR (using RECIST 1.1) by immunohistochemistry (IHC) [Up to 64 months]

    8. Overall survival (OS) by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC) [Up to 64 months]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Birmingham Alabama United States 35223
    2 Local Institution Birmingham Alabama United States 35233
    3 Alaska Urological Institute dba Alaska Clinical Research Center Anchorage Alaska United States 99503
    4 Local Institution Little Rock Arkansas United States 72205
    5 Local Institution - 0115 Fresno California United States 93703
    6 Local Institution Santa Rosa California United States 95403
    7 Boca Raton Regional Hospital Boca Raton Florida United States 33486
    8 Holy Cross Hospital Fort Lauderdale Florida United States 33308
    9 Cancer Specialists of North FL Jacksonville Florida United States 32256
    10 University Cancer & Blood Center, LLC Athens Georgia United States 30607
    11 Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital Thomasville Georgia United States 31792
    12 University Of Illinois At Chicago Chicago Illinois United States 60612
    13 Local Institution Iowa City Iowa United States 55242
    14 Local Institution - 0117 New Orleans Louisiana United States 70121
    15 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    16 Local Institution - 0073 Boston Massachusetts United States 02215
    17 Milford Regional Medical Center Boston Massachusetts United States 02215
    18 South Shore Hospital Cancer Center South Weymouth Massachusetts United States 02190
    19 St. Joseph Mercy Hospital Ypsilanti Michigan United States 48197
    20 Ridges Cancer Clinic Burnsville Minnesota United States 55337
    21 Hattiesburg Clinic Hattiesburg Mississippi United States 39401
    22 Washington University School OF Medicine-Siteman Cancer Center Saint Louis Missouri United States 63110
    23 GU Research Network, LLC Omaha Nebraska United States 68130
    24 Local Institution - 0057 Manchester New Hampshire United States 03103
    25 University Of New Mexico Albuquerque New Mexico United States 87131
    26 Roswell Park Cancer Institute Buffalo New York United States 14263
    27 NYU Winthrop Hospital Dept of Oncology/Hematology Mineola New York United States 11501
    28 Icahn School Of Medicine At Mount Sinai New York New York United States 10029
    29 Local Institution New York New York United States 10065
    30 Local Institution - 0116 Durham North Carolina United States 27710
    31 The Ohio State University Columbus Ohio United States 43210
    32 Providence Portland Med Ctr Portland Oregon United States 97213
    33 St Lukes Hospital Easton Pennsylvania United States 18045
    34 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    35 Local Institution Houston Texas United States 77030
    36 Local Institution Salt Lake City Utah United States 84112
    37 Seattle Cancer Care Alliance Kirkland Washington United States 98034
    38 Local Institution Milwaukee Wisconsin United States 53226
    39 Local Institution - 0005 Capital Federal Buenos Aires Argentina 1426
    40 Local Institution - 0007 Mar Del Plata Buenos Aires Argentina 7600
    41 Local Institution - 0008 Viedma RIO Negro Argentina 8500
    42 Local Institution - 0009 Buenos Aires Argentina 1120
    43 Local Institution - 0134 Cordoba Argentina 5000
    44 Local Institution - 0006 Cordoba Argentina 5004
    45 Local Institution Darlinghurst New South Wales Australia 2010
    46 Local Institution - 0096 Waratah New South Wales Australia 2298
    47 Local Institution - 0099 Westmead New South Wales Australia 2145
    48 Local Institution - 0188 South Brisbane Queensland Australia 4101
    49 Local Institution - 0120 Tugun Queensland Australia 4224
    50 Local Institution - 0101 Heidelberg Victoria Australia 3084
    51 Local Institution - 0100 Doubleview Western Australia Australia 6018
    52 Local Institution - 0017 Brasilia Distrito Federal Brazil 70200-730
    53 Local Institution - 0021 Ijui RIO Grande DO SUL Brazil 98700-000
    54 Local Institution - 0119 Passo Fundo RIO Grande DO SUL Brazil 99010-080
    55 Local Institution - 0020 Porto Alegre RIO Grande DO SUL Brazil 90610000
    56 Local Institution - 0016 Florianopolis Santa Catarina Brazil 88034-000
    57 Local Institution - 0018 Barretos Sao Paulo Brazil 14784-400
    58 Local Institution - 0019 Sao Jose Do Rio Preto Sao Paulo Brazil 15090-000
    59 Local Institution Sao Paulo Brazil 01509-900
    60 Local Institution - 0053 Halifax Nova Scotia Canada B3H 2Y9
    61 Local Institution - 0064 London Ontario Canada N6A 4L6
    62 Local Institution - 0052 Sherbrooke Quebec Canada J1H 5N4
    63 Local Institution - 0054 Quebec Canada G1R 2J6
    64 Local Institution - 0010 Santiago Metropolitana Chile 8420383
    65 Local Institution Santiago Metropolitana Chile
    66 Local Institution - 0012 Vina del Mar Valparaiso Chile 2520598
    67 Local Institution - 0106 Vitacura Chile 0
    68 Local Institution - 0171 Beijing Beijing China 100001
    69 Local Institution - 0169 Beijing Beijing China 100034
    70 Local Institution - 0182 Chongqing Chongqing China 400030
    71 Local Institution Guiyang Guizhou China 550002
    72 Local Institution - 0219 Harbin Heilongjiang China 150000
    73 Local Institution - 0180 Wuhan Hubei China 430030
    74 Local Institution - 0177 Nanjing Jiangsu China 210000
    75 Local Institution - 0176 Nanjing Jiangsu China 210008
    76 Local Institution - 0175 Nanjng Jiangsu China 0
    77 Local Institution - 0186 Changchun Jilin China 130021
    78 Local Institution - 0220 Taiyuan Shan1xi China 030001
    79 Local Institution - 0216 Yantai Shandong China 264000
    80 Local Institution - 0167 Shanghai Shanghai China 200025
    81 Local Institution - 0162 Shanghai Shanghai China 200032
    82 Local Institution - 0163 Shanghai Shanghai China 200040
    83 Local Institution Shanghai Shanghai China 200433
    84 Local Institution - 0184 Chengdu Sichuan China 610041
    85 Local Institution - 0174 Hangzhou Zhejiang China 310009
    86 Local Institution - 0172 Hangzhou Zhejiang China 310014
    87 Local Institution - 0173 Hangzhou Zhejiang China 310022
    88 Local Institution - 0170 Beijing China 100083
    89 Local Institution - 0164 Shanghai China 200032
    90 Local Institution - 0160 Brno Czechia 656 53
    91 Local Institution - 0152 Hradec Kralove Czechia 500 05
    92 Local Institution - 0190 Aalborg Denmark 9210
    93 Local Institution - 0196 Herlev Denmark 2730
    94 Local Institution Helsinki Finland 00029
    95 Local Institution - 0089 Lille France 59000
    96 Local Institution - 0088 Marseille Cedex 9 France 13273
    97 Local Institution - 0091 Nimes Cedex 09 France 30029
    98 Local Institution - 0090 St Priest En Jarez France 42271
    99 Local Institution - 0092 Suresnes France 92151
    100 Local Institution - 0093 Tours Cedex France 37044
    101 Local Institution - 0094 Villejuif France 94805
    102 Universitat Dresden Dresden Germany 01307
    103 Local Institution - 0048 Essen Germany 45147
    104 Local Institution - 0047 Freiburg Germany 79106
    105 Local Institution - 0049 Hamburg Germany 22763
    106 Local Institution - 0037 Hannover Germany 30625
    107 Local Institution - 0041 Jena Germany 07747
    108 Local Institution - 0213 Mannheim Germany 68167
    109 Local Institution Muenchen Germany 81675
    110 Local Institution - 0038 Nuernberg Germany 90419
    111 Local Institution - 0040 Tuebingen Germany 72076
    112 Local Institution - 0114 Weiden Germany 92637
    113 Local Institution - 0039 Wuerzburg Germany 97080
    114 Local Institution - 0102 Athens Greece 11528
    115 Local Institution - 0103 Ioannina Greece 45500
    116 Local Institution Budapest Hungary 1082
    117 Local Institution Budapest Hungary 1122
    118 Local Institution Budapest Hungary 1145
    119 Local Institution Debrecen Hungary
    120 Local Institution Miskolc Hungary 3526
    121 Local Institution - 0199 Kfar Saba Israel 44281
    122 Local Institution - 0198 Ramat Gan Israel 52621
    123 Local Institution - 0108 Arezzo Italy 52100
    124 Local Institution - 0197 Faenza Italy 48018
    125 Local Institution - 0111 Forlì Italy 47014
    126 Local Institution - 0109 Grosseto Italy 58100
    127 Local Institution - 0107 Milano Italy 20133
    128 Local Institution - 0110 Napoli Italy 80131
    129 Local Institution - 0136 Hirosaki-shi Aomori Japan 036-8563
    130 Local Institution - 0135 Chiba-shi Chiba Japan 260-8717
    131 Local Institution - 0147 Matsuyama-shi Ehime Japan 7910280
    132 Local Institution - 0140 Fukuoka-shi Fukuoka Japan 8128582
    133 Local Institution - 0146 Sapporo-city Hokkaido Japan 0608543
    134 Local Institution - 0150 Tsukuba-shi Ibaraki Japan 3058576
    135 Local Institution - 0214 Morioka-shi Iwate Japan 0208505
    136 Local Institution - 0137 Kita-Gun Kagawa Japan 7610793
    137 Local Institution - 0141 Niigata-shi Niigata Japan 9518520
    138 Local Institution - 0143 Okayama-shi Okayama Japan 7008558
    139 Local Institution - 0144 Osaka-shi Osaka Japan 5418567
    140 Local Institution - 0139 Osakasayama Osaka Japan 589-8511
    141 Local Institution - 0145 Takatsuki-shi Osaka Japan 5698686
    142 Local Institution - 0201 Hamamatasu Shizuoka Japan 431-3192
    143 Local Institution - 0149 Arakawa-ku,tokyo Tokyo Japan 1168567
    144 Local Institution - 0148 Bunkyo-ku Tokyo Japan 1138519
    145 Local Institution - 0142 Bunkyo-ku Tokyo Japan 1138602
    146 Local Institution - 0138 Shinjuku-Ku Tokyo Japan 1608582
    147 Local Institution - 0215 Wakayama-shi Wakayama Japan 641-8510
    148 Local Institution Ube City Yamaguchi Japan 755-8505
    149 Local Institution - 0125 Goyang-si Gyeonggido Korea, Republic of 10408
    150 Local Institution - 0126 Seongnam-si Korea, Republic of 13620
    151 Local Institution - 0124 Seoul Korea, Republic of 03080
    152 Local Institution - 0151 Seoul Korea, Republic of 03722
    153 Local Institution - 0128 Seoul Korea, Republic of 05505
    154 Local Institution - 0127 Seoul Korea, Republic of 06351
    155 Local Institution - 0129 Ciudad de Mexico Distrito Federal Mexico 06100
    156 Local Institution Mexico City Distrito Federal Mexico 07760
    157 Local Institution - 0130 Tlalpan Distrito Federal Mexico 14080
    158 Local Institution - 0131 Monterrey Nuevo Leon Mexico 64460
    159 Local Institution - 0022 Amsterdam Netherlands 1066 CX
    160 Local Institution Enschede Netherlands 7512KZ
    161 Local Institution - 0024 Groningen Netherlands 9713 GZ
    162 Local Institution - 0026 Leeuwarden Netherlands 8934 AD
    163 Local Institution Bergen Norway 5021
    164 Local Institution - 0081 Lorenskog Norway 1478
    165 Local Institution - 0030 Lima Peru 34
    166 Local Institution - 0031 Lima Peru Lima 27
    167 Local Institution - 0189 Bydgoszcz Poland 85-796
    168 Local Institution - 0205 Koszalin Poland 75-581
    169 Local Institution - 0202 Warszawa Poland 02-781
    170 Local Institution - 0191 Cluj-Napoca Cluj Romania 400015
    171 Local Institution - 0187 Craiova Romania 200347
    172 Local Institution Moscow Russian Federation 115478
    173 Local Institution Moscow Russian Federation 117997
    174 Local Institution Moscow Russian Federation 125367
    175 Local Institution Novosibirsk Russian Federation 630099
    176 Local Institution St Petersburg Russian Federation 198255
    177 Local Institution - 0192 Singapore Singapore 169610
    178 Local Institution - 0070 A Coruna Spain 15006
    179 Local Institution - 0068 Barcelona Spain 08025
    180 Local Institution - 0065 Madrid Spain 28034
    181 Local Institution - 0066 Madrid Spain 28041
    182 Local Institution - 0209 Santander Spain 39008
    183 Local Institution - 0067 Sevilla Spain 41013
    184 Local Institution - 0069 Valencia Spain 46009
    185 Local Institution - 0075 Jonkoping Sweden 553 05
    186 Local Institution Linkoping Sweden 581 85
    187 Local Institution Lund Sweden 221 85
    188 Local Institution - 0061 Baden Switzerland 5404
    189 Local Institution - 0042 Chur Switzerland 7000
    190 Local Institution - 0156 Kaohsiung Taiwan 833
    191 Local Institution - 0159 Taichung Taiwan 40705
    192 Local Institution - 0158 Taipei Taiwan 100
    193 Local Institution - 0155 Taipei Taiwan 11217
    194 Local Institution - 0157 Taoyuan Taiwan 333
    195 Local Institution - 0194 Ankara Turkey 06590
    196 Local Institution - 0204 Istanbul Turkey 34300
    197 Local Institution - 0193 Izmir Turkey 35340

    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:
    NCT03036098
    Other Study ID Numbers:
    • CA209-901
    • 2016-003881-14
    First Posted:
    Jan 30, 2017
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gemcitabine
    Carboplatin
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Jul 28, 2022