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)

February 22, 2026 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1314

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study
Time Frame: 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)

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
Time Frame: 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)

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
Time Frame: 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)
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
Time Frame: 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)

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in All Randomized Participants for Primary Study
Time Frame: 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)

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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)

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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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)

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
Time Frame: 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)

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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ono Pharmaceutical Co. Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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