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 (CheckMate901)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urothelial Cancer
• Intervention / Treatment: Biological: Nivolumab; Biological: Ipilimumab; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Actual): 1314
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1120
    • Local Institution - 0009
  • Córdoba, Argentina, 5000
    • Local Institution - 0134
  • Córdoba, Argentina, 5004
    • Local Institution - 0006
  • Viedma, Argentina, 8500
    • Local Institution - 0008
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, 1426
      • Local Institution - 0005
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Local Institution - 0007
• Australia
  • New South Wales
    • Waratah, New South Wales, Australia, 2298
      • Local Institution - 0096
    • Westmead, New South Wales, Australia, 2145
      • Local Institution - 0099
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Local Institution - 0188
    • Tugun, Queensland, Australia, 4224
      • Local Institution - 0120
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Local Institution - 0101
  • Western Australia
    • Doubleview, Western Australia, Australia, 6018
      • Local Institution - 0100
• Brazil
  • Federal District
    • Brasília, Federal District, Brazil, 70200-730
      • Local Institution - 0017
  • Rio Grande do Sul
    • Ijuí, Rio Grande do Sul, Brazil, 98700-000
      • Local Institution - 0021
    • Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
      • Local Institution - 0119
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610000
      • Local Institution - 0020
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil, 88034-000
      • Local Institution - 0016
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Local Institution - 0018
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Local Institution - 0019
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Local Institution - 0053
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • Local Institution - 0064
  • Quebec
    • Québec, Quebec, Canada, G1J 1Z4
      • Local Institution - 0054
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Local Institution - 0052
• Chile
  • Vitacura, Chile
    • Local Institution - 0106
  • Región de Valparaíso
    • Viña del Mar, Región de Valparaíso, Chile, 2520598
      • Local Institution - 0012
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 8420383
      • Local Institution - 0010
• China
  • Beijing, China, 100083
    • Local Institution - 0170
  • Shanghai, China, 200032
    • Local Institution - 0164
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100001
      • Local Institution - 0171
    • Beijing, Beijing Municipality, China, 100034
      • Local Institution - 0169
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Local Institution - 0182
  • Guizhou
    • Guiyang, Guizhou, China, 550002
      • Local Institution - 0217
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Local Institution - 0219
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Local Institution - 0180
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Local Institution - 0177
    • Nanjing, Jiangsu, China, 210008
      • Local Institution - 0176
    • Nanjing, Jiangsu, China
      • Local Institution - 0175
  • Jilin
    • Changchun, Jilin, China, 130021
      • Local Institution - 0186
  • Shan1xi
    • Taiyuan, Shan1xi, China, 030001
      • Local Institution - 0220
  • Shandong
    • Yantai, Shandong, China, 264000
      • Local Institution - 0216
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Local Institution - 0167
    • Shanghai, Shanghai Municipality, China, 200032
      • Local Institution - 0162
    • Shanghai, Shanghai Municipality, China, 200040
      • Local Institution - 0163
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Local Institution - 0184
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Local Institution - 0174
    • Hangzhou, Zhejiang, China, 310014
      • Local Institution - 0172
    • Hangzhou, Zhejiang, China
      • Local Institution - 0173
• Czechia
  • Brno, Czechia, 656 53
    • Local Institution - 0160
  • Hradec Králové, Czechia, 500 05
    • Local Institution - 0152
• Denmark
  • Aalborg, Denmark, 9210
    • Local Institution - 0190
  • Herlev, Denmark, 2730
    • Local Institution - 0196
• Finland
  • Helsinki, Finland, 00029
    • Local Institution - 0060
• France
  • Lille, France, 59000
    • Local Institution - 0089
  • Marseille, France, 13273
    • Local Institution - 0088
  • Saint-Priest-en-Jarez, France, 42271
    • Local Institution - 0090
  • Suresnes, France, 92151
    • Local Institution - 0092
  • Tours, France, 37044
    • Local Institution - 0093
  • Villejuif, France, 94805
    • Local Institution - 0094
  • Gard
    • Nîmes, Gard, France, 30029
      • Local Institution - 0091
• Germany
  • Dresden, Germany, 01307
    • Local Institution - 0036
  • Essen, Germany, 45147
    • Local Institution - 0048
  • Freiburg im Breisgau, Germany, 79106
    • Local Institution - 0047
  • Hamburg, Germany, 22763
    • Local Institution - 0049
  • Hanover, Germany, 30625
    • Local Institution - 0037
  • Jena, Germany, 07747
    • Local Institution - 0041
  • Mannheim, Germany, 68167
    • Local Institution - 0213
  • Nuremberg, Germany, 90419
    • Local Institution - 0038
  • Tübingen, Germany, 72076
    • Local Institution - 0040
  • Weiden, Germany, 92637
    • Local Institution - 0114
  • Würzburg, Germany, 97080
    • Local Institution - 0039
• Greece
  • Athens, Greece, 115 28
    • Local Institution - 0102
  • Ípeiros
    • Ioannina, Ípeiros, Greece, 455 00
      • Local Institution - 0103
• Israel
  • Kfar Saba, Israel, 44281
    • Local Institution - 0199
  • Ramat Gan, Israel, 52621
    • Local Institution - 0198
• Italy
  • Arezzo, Italy, 52100
    • Local Institution - 0108
  • Faenza, Italy, 48018
    • Local Institution - 0197
  • Forlì, Italy, 47014
    • Local Institution - 0111
  • Grosseto, Italy, 58100
    • Local Institution - 0109
  • Milan, Italy, 20133
    • Local Institution - 0107
  • Napoli, Italy, 80131
    • Local Institution - 0110
• Japan
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8563
      • Local Institution - 0136
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Local Institution - 0135
  • Ehime
    • Matsuyama, Ehime, Japan, 7910280
      • Local Institution - 0147
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 8128582
      • Local Institution - 0140
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 0608543
      • Local Institution - 0146
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 3058576
      • Local Institution - 0150
  • Iwate
    • Morioka, Iwate, Japan, 0208505
      • Local Institution - 0214
  • Kagawa-ken
    • Kita-Gun, Kagawa-ken, Japan, 7610793
      • Local Institution - 0137
  • Niigata
    • Niigata, Niigata, Japan, 9518520
      • Local Institution - 0141
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 7008558
      • Local Institution - 0143
  • Osaka
    • Osaka, Osaka, Japan, 5418567
      • Local Institution - 0144
    • Sayama, Osaka, Japan, 589-8511
      • Local Institution - 0139
    • Takatsuki-shi, Osaka, Japan, 5698686
      • Local Institution - 0145
  • Shizuoka
    • Hamamatasu, Shizuoka, Japan, 431-3192
      • Local Institution - 0201
  • Tokyo
    • Adachi-ku, Tokyo, Japan, 1168567
      • Local Institution - 0149
    • Bunkyo-ku, Tokyo, Japan, 1138519
      • Local Institution - 0148
    • Bunkyo-ku, Tokyo, Japan, 1138602
      • Local Institution - 0142
    • Shinjuku-Ku, Tokyo, Japan, 1608582
      • Local Institution - 0138
  • Wakayama
    • Wakayama, Wakayama, Japan, 641-8510
      • Local Institution - 0215
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Local Institution - 0200
• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06100
      • Local Institution - 0129
    • Mexico City, Mexico City, Mexico, 07760
      • Local Institution - 0154
    • Tlalpan, Mexico City, Mexico, 14080
      • Local Institution - 0130
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Local Institution - 0131
• Netherlands
  • Enschede, Netherlands, 7512KZ
    • Local Institution - 0055
  • Groningen, Netherlands, 9713 GZ
    • Local Institution - 0024
  • Leeuwarden, Netherlands, 8934 AD
    • Local Institution - 0026
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066 CX
      • Local Institution - 0022
• Norway
  • Bergen, Norway, 5021
    • Local Institution - 0074
  • Lorenskog, Norway, 1478
    • Local Institution - 0081
• Peru
  • Lima, Peru, 34
    • Local Institution - 0030
  • Lima, Peru, 15076
    • Local Institution - 0031
• Poland
  • Bydgoszcz, Poland, 85-796
    • Local Institution - 0189
  • Koszalin, Poland, 75-581
    • Local Institution - 0205
  • Warsaw, Poland, 02-781
    • Local Institution - 0202
• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400015
      • Local Institution - 0191
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • Local Institution - 0187
• Russia
  • Moscow, Russia, 125367
    • Local Institution
• Singapore
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 168583
      • Local Institution - 0192
• South Korea
  • Seongnam-si, South Korea, 13620
    • Local Institution - 0126
  • Seoul, South Korea, 03080
    • Local Institution - 0124
  • Seoul, South Korea, 03722
    • Local Institution - 0151
  • Seoul, South Korea, 05505
    • Local Institution - 0128
  • Seoul, South Korea, 06351
    • Local Institution - 0127
  • Gyeonggido
    • Goyang-si, Gyeonggido, South Korea, 10408
      • Local Institution - 0125
• Spain
  • A Coruña, Spain, 15006
    • Local Institution - 0070
  • Barcelona, Spain, 08025
    • Local Institution - 0068
  • Madrid, Spain, 28034
    • Local Institution - 0065
  • Madrid, Spain, 28041
    • Local Institution - 0066
  • Santander, Spain, 39008
    • Local Institution - 0209
  • Seville, Spain, 41013
    • Local Institution - 0067
  • Valencia, Spain, 46009
    • Local Institution - 0069
• Sweden
  • Jönköping, Sweden, 553 05
    • Local Institution - 0075
  • Linköping, Sweden, 581 85
    • Local Institution - 0059
  • Lund, Sweden, 221 85
    • Local Institution - 0058
• Switzerland
  • Chur, Switzerland, 7000
    • Local Institution - 0042
  • Canton of Aargau
    • Baden, Canton of Aargau, Switzerland, 5404
      • Local Institution - 0061
• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Local Institution - 0156
  • Taichung, Taiwan, 40705
    • Local Institution - 0159
  • Taipei, Taiwan, 100
    • Local Institution - 0158
  • Taipei, Taiwan, 11217
    • Local Institution - 0155
  • Taoyuan District, Taiwan, 333
    • Local Institution - 0157
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06590
    • Local Institution - 0194
  • Istanbul, Turkey (Türkiye), 34300
    • Local Institution - 0204
  • Izmir, Turkey (Türkiye), 35340
    • Local Institution - 0193
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Local Institution - 0001
  • California
    • Fresno, California, United States, 93703
      • Local Institution - 0115
    • Santa Rosa, California, United States, 95403
      • St Joseph Heritage Healthcare
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Local Institution - 0051
    • Fort Lauderdale, Florida, United States, 33308
      • Local Institution - 0087
    • Jacksonville, Florida, United States, 32256
      • Local Institution - 0062
  • Georgia
    • Athens, Georgia, United States, 30607
      • Local Institution - 0004
    • Thomasville, Georgia, United States, 31792
      • Local Institution - 0033
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Local Institution - 0046
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Local Institution - 0117
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0073
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0208
    • Boston, Massachusetts, United States, 02210
      • Local Institution - 0056
    • Milford, Massachusetts, United States, 01757
      • Local Institution - 0207
  • Michigan
    • Ann Arbor, Michigan, United States, 48197
      • Local Institution - 0063
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Local Institution - 0002
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111-3220
      • Local Institution - 0032
    • St Louis, Missouri, United States, 63110
      • Local Institution - 0095
  • New Hampshire
    • Manchester, New Hampshire, United States, 03103
      • Local Institution - 0057
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Local Institution - 0084
  • New York
    • Buffalo, New York, United States, 14263
      • Local Institution - 0083
    • Mineola, New York, United States, 11501
      • Local Institution - 0014
    • New York, New York, United States, 10029
      • Local Institution - 0072
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Local Institution - 0116
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Local Institution - 0082
  • Oregon
    • Portland, Oregon, United States, 97213
      • Local Institution - 0104
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Local Institution - 0013
  • Washington
    • Kirkland, Washington, United States, 98034
      • Local Institution - 0086

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study	This measure looks at how long participants who cannot receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are unable to receive cisplatin chemotherapy live longer.	From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study	This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help people with PD-L1 positive tumors live longer.	From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-study	This measure looks at how long people who can receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the sub-study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people eligible for cisplatin live longer without their cancer progressing.	From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
Overall Survival (OS) in Cisplatin-eligible Participants for Sub-study	This measure looks at how long people who are able to receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the sub-study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are eligible for cisplatin chemotherapy live longer.	From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in All Randomized Participants for Primary Study	This measure looks at how long all participants live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help all participants in the study live longer.	From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
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 for Primary Study	This measure looks at how long people who cannot receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people unable to receive cisplatin live longer without their cancer progressing.	From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Participants for Primary Study	This measure looks at how long people with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a lab test) live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people with PD-L1 positive tumors live longer without their cancer progressing.	From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in All Randomized Participants for Primary Study	This measure looks at how long all participants in the primary study live without their cancer getting worse after being assigned to a treatment group. Progression-Free Survival (PFS) is defined as the time from when a participant is assigned to a treatment group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment the participant received. These experts use standard rules (called RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand whether the treatment can help participants live longer without their cancer progressing.	From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score in All Randomized Participants for Primary Study	The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.	At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 144, Week 156, Week 168, Week 180 and Week 192
Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for Sub-study	The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.	At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, and Week 120
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] by Programmed Death-Ligand 1 (PD-L1) Expression at ≥1% Expression by Immunohistochemistry (IHC) for Sub-study	This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a lab test called immunohistochemistry or IHC) live without their cancer getting worse after being assigned to a treatment group in the sub-study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check.	From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
Overall Survival (OS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] by Programmed Death-Ligand 1 (PD-L1) Expression at ≥1% Expression by Immunohistochemistry (IHC) for Sub-study	This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) live after being placed into a treatment group in the sub-study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help people with PD-L1 positive tumors live longer. The results are reviewed by independent experts who do not know which treatment each participant received, using standard criteria for measuring tumor response.	From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• van der Heijden MS, Sonpavde G, Powles T, Necchi A, Burotto M, Schenker M, Sade JP, Bamias A, Beuzeboc P, Bedke J, Oldenburg J, Chatta G, Urun Y, Ye D, He Z, Valderrama BP, Ku JH, Tomita Y, Filian J, Wang L, Purcea D, Patel MY, Nasroulah F, Galsky MD; CheckMate 901 Trial Investigators. Nivolumab plus Gemcitabine-Cisplatin in Advanced Urothelial Carcinoma. N Engl J Med. 2023 Nov 9;389(19):1778-1789. doi: 10.1056/NEJMoa2309863. Epub 2023 Oct 22.
• Tomita Y, Ye DW, Fujii A, Takeuchi N. Nivolumab plus gemcitabine-cisplatin for previously untreated unresectable or metastatic urothelial carcinoma: an Asian subgroup analysis from the global phase 3 CheckMate 901 trial. Urol Oncol. 2025 Dec;43(12):696.e9-696.e16. doi: 10.1016/j.urolonc.2025.08.022. Epub 2025 Sep 26.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2017
• Primary Completion (Actual): August 30, 2024
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimated): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Platinum Compounds; Nivolumab; Ipilimumab; Gemcitabine; Carboplatin; Cisplatin
• Other Study ID Numbers: CA209-901; 2016-003881-14 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No