An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer (CheckMate 274)

July 6, 2026 updated by: Bristol-Myers Squibb

A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.
709

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
      • Viedma, Argentina, 8500
        • Local Institution - 0102
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, 1880
        • Local Institution - 0021
      • Capital Federal, Buenos Aires, Argentina, 1426
        • Local Institution - 0090
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1181
        • Local Institution - 0089
      • Ciudad Autónoma de BuenosAires, Buenos Aires, Argentina, C1280AEB
        • Local Institution - 0022
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Local Institution - 0020
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Local Institution - 0048
      • St Leonards, New South Wales, Australia, 2065
        • Local Institution - 0047
      • Waratah, New South Wales, Australia, 2298
        • Local Institution - 0046
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Local Institution - 0050
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Local Institution - 0184
    • Western Australia
      • Perth, Western Australia, Australia, 6150
        • Local Institution - 0175
  • Austria
      • Linz, Austria, 4010
        • Local Institution - 0133
      • Salzburg, Austria, 5020
        • Local Institution - 0136
      • Vienna, Austria, 1090
        • Local Institution - 0132
      • Vienna, Austria, 1090
        • Local Institution - 0183
  • Belgium
      • Hasselt, Belgium, 3500
        • Local Institution - 0029
      • Liège, Belgium, 4000
        • Local Institution - 0027
  • Brazil
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Local Institution - 0071
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610000
        • Local Institution - 0072
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20231-050
        • Local Institution - 0231
    • São Paulo
      • Barretos, São Paulo, Brazil, 14780-070
        • Local Institution - 0070
      • Cerqueira César, São Paulo, Brazil, 01246-000
        • Local Institution - 0073
      • São Paulo, São Paulo, Brazil, 04014-002
        • Local Institution - 0100
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0139
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Local Institution - 0109
      • Montreal, Quebec, Canada, H2X 0A9
        • Local Institution - 0101
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution - 0112
  • Chile
      • Temuco, Chile, 4810297
        • Local Institution - 0137
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile
        • Local Institution - 0099
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2540364
        • Local Institution - 0038
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100001
        • Local Institution - 0191
      • Beijing, Beijing Municipality, China, 100034
        • Local Institution - 0206
      • Beijing, Beijing Municipality, China, 100050
        • Local Institution - 0192
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Local Institution - 0210
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Local Institution - 0198
    • Guangdong
      • Guangzhou, Guangdong, China, 510230
        • Local Institution - 0222
      • Guangzhou, Guangdong, China, 510288
        • Local Institution - 0203
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Local Institution - 0227
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Local Institution - 0196
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Local Institution - 0220
      • Nanjing, Jiangsu, China, 210029
        • Local Institution - 0204
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Local Institution - 0223
    • Shan3xi
      • Xi'an, Shan3xi, China, 710061
        • Local Institution
    • Shandong
      • Yantai, Shandong, China, 264000
        • Local Institution - 0212
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Local Institution - 0193
      • Shanghai, Shanghai Municipality, China, 200032
        • Local Institution - 0202
      • Shanghai, Shanghai Municipality, China, 200040
        • Local Institution - 0199
      • Shanghai, Shanghai Municipality, China, 200040
        • Local Institution - 0217
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0229
      • Chengdu, Sichuan, China, 610072
        • Local Institution - 0219
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Local Institution - 0221
      • Hangzhou, Zhejiang, China, 310014
        • Local Institution - 0195
      • Wenzhou, Zhejiang, China, 32500
        • Local Institution - 0230
  • Colombia
      • Bogotá, Colombia
        • Local Institution - 0092
      • Floridablanca, Colombia, 681004
        • Local Institution - 0093
      • Medellín, Colombia, 050034
        • Local Institution - 0091
  • Denmark
      • Aalborg, Denmark, 9100
        • Local Institution - 0108
      • Aarhus N, Denmark, 8200
        • Local Institution - 0106
      • Copenhagen, Denmark, 2100
        • Local Institution - 0107
  • France
      • Clermont-Ferrand, France, 63000
        • Local Institution - 0233
      • La Roche-sur-Yon, France, 85000
        • Local Institution - 0115
      • Marseille, France, 13273
        • Local Institution - 0080
      • Paris, France, 75475
        • Local Institution - 0081
      • Strasbourg, France, 67200
        • Local Institution - 0113
      • Suresnes, France, 92151
        • Local Institution - 0097
      • Villejuif, France, 94800
        • Local Institution - 0098
  • Germany
      • Chemnitz, Germany, 09130
        • Local Institution - 0131
      • Essen, Germany, 45136
        • Local Institution - 0125
      • Greifswald, Germany, 17475
        • Local Institution - 0127
      • Hamburg, Germany, 20246
        • Local Institution - 0126
      • Heidelberg, Germany, 69126
        • Local Institution - 0124
      • Jena, Germany, 07747
        • Local Institution - 0123
      • Marburg, Germany, 35043
        • Local Institution - 0188
      • Munich, Germany, 81675
        • Local Institution - 0122
      • Münster, Germany, 48149
        • Local Institution - 0128
      • Nuremberg, Germany, 90419
        • Local Institution - 0185
      • Regensburg, Germany, 93053
        • Local Institution - 0130
      • Stuttgart, Germany, 70174
        • Local Institution - 0129
  • Greece
      • Athens, Greece, 115 28
        • Local Institution - 0110
      • Thessaloniki, Greece, 54007
        • Local Institution - 0111
  • Ireland
    • CORK
      • Wilton, CORK, Ireland
        • Local Institution - 0054
    • Dublin
      • Dublin, Dublin, Ireland
        • Local Institution - 0052
  • Israel
      • Haifa, Israel, 3109601
        • Local Institution - 0118
      • Jerusalem, Israel, 91120
        • Local Institution - 0121
      • Ramat Gan, Israel, 5262100
        • Local Institution - 0120
      • Ẕerifin, Israel, 70300
        • Local Institution - 0119
  • Italy
      • Arezzo, Italy, 52100
        • Local Institution - 0088
      • Bergamo, Italy, 24127
        • Local Institution - 0197
      • Milan, Italy, 20133
        • Local Institution - 0082
      • Pisa, Italy, 56126
        • Local Institution - 0084
      • Reggio Emilia, Italy, 42100
        • Local Institution - 0189
      • Roma, Italy, 00144
        • Local Institution - 0085
      • Roma, Italy, 00152
        • Local Institution - 0086
      • Siena, Italy, 53100
        • Local Institution - 0083
  • Japan
    • Akita
      • Akita, Akita, Japan, 0108543
        • Local Institution - 0142
    • Aomori
      • Hirosaki, Aomori, Japan, 0368563
        • Local Institution - 0144
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Local Institution - 0143
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 8128582
        • Local Institution - 0162
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Local Institution - 0160
      • Sapporo, Hokkaido, Japan, 0608648
        • Local Institution - 0161
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 3058576
        • Local Institution - 0148
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 8528501
        • Local Institution - 0163
    • Niigata
      • Niigata, Niigata, Japan, 9518520
        • Local Institution - 0150
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Local Institution - 0141
    • Osaka
      • Osaka, Osaka, Japan, 5418567
        • Local Institution - 0164
      • Sayama, Osaka, Japan, 589-8511
        • Local Institution - 0149
    • Shizuoka
      • Hamamatasu, Shizuoka, Japan, 431-3192
        • Local Institution - 0151
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138603
        • Local Institution - 0146
      • Shinjuku-Ku, Tokyo, Japan, 1608582
        • Local Institution - 0145
      • Shinjuku-ku, Tokyo, Japan, 1628666
        • Local Institution - 0147
  • Mexico
      • México, Mexico, 06700
        • Local Institution - 0116
      • México, Mexico, 14080
        • Local Institution - 0039
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44270
        • Local Institution - 0035
    • Mexico City
      • Df, Mexico City, Mexico, 06720
        • Local Institution - 0138
      • Mexico City, Mexico City, Mexico, 14080
        • Local Institution - 0034
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Local Institution - 0032
  • Netherlands
      • Maastrict, Netherlands, 6229 HX
        • Local Institution - 0068
      • Nijmegen, Netherlands, 6500 HB
        • Local Institution - 0041
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HV
        • Local Institution - 0069
  • Peru
      • Lima, Peru, Lima 41
        • Local Institution - 0043
  • Poland
      • Gdansk, Poland, 80-214
        • Local Institution - 0055
      • Lodz, Poland, 93-513
        • Local Institution - 0057
      • Warsaw, Poland, 02-797
        • Local Institution - 0187
      • Wroclaw, Poland, 50-556
        • Local Institution - 0058
      • Wroclaw, Poland, 53-413
        • Local Institution - 0186
  • Romania
      • Bucharest, Romania, 021389
        • Local Institution - 0182
      • Craiova, Romania, 200347
        • Local Institution - 0096
      • Floreşti, Romania, 407280
        • Local Institution - 0078
      • Timisoara, Timis, Romania, 300239
        • Local Institution - 0181
  • Russia
      • Moscow, Russia, 125284
        • Local Institution - 0140
      • Saint Petersburg, Russia, 197758
        • Local Institution - 0031
  • South Korea
      • Seongnam-si, South Korea, 13620
        • Local Institution - 0155
      • Seoul, South Korea, 03722
        • Local Institution - 0154
      • Seoul, South Korea, 05505
        • Local Institution - 0152
      • Seoul, South Korea, 06351
        • Local Institution - 0156
  • Spain
      • Badalona-barcelona, Spain, 08916
        • Local Institution - 0067
      • Barcelona, Spain, 08035
        • Local Institution - 0066
      • Madrid, Spain, 28007
        • Local Institution - 0064
      • Madrid, Spain, 28034
        • Local Institution - 0062
      • Madrid, Spain, 28041
        • Local Institution - 0063
      • Santander, Spain, 39008
        • Local Institution - 0232
      • Seville, Spain, 41013
        • Local Institution - 0065
  • Sweden
      • Lund, Sweden, 221 85
        • Local Institution - 0105
  • Switzerland
      • Basel, Switzerland, 4031
        • Local Institution - 0134
      • Zurich, Switzerland, 8038
        • Local Institution - 0135
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Local Institution - 0158
      • Taichung, Taiwan, 404
        • Local Institution - 0159
      • Taipei, Taiwan, 100
        • Local Institution - 0153
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Local Institution - 0036
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution - 0025
    • London
      • London, London, United Kingdom, SW3 6JJ
        • Local Institution - 0114
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • Local Institution - 0076
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Local Institution - 0024
    • Yorkshire
      • Sheffield, Yorkshire, United Kingdom, S10 2SJ
        • Local Institution - 0059
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Alaska Urological Institute dba Alaska Clinical Research Center
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Local Institution - 0179
    • California
      • Clovis, California, United States, 93611
        • Local Institution - 0061
      • Sacramento, California, United States, 95817
        • Local Institution - 0172
      • San Francisco, California, United States, 94115
        • Local Institution - 0005
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Local Institution - 0178
    • Florida
      • Gainesville, Florida, United States, 32610
        • Local Institution - 0167
      • Miami Beach, Florida, United States, 33140
        • Local Institution - 0030
      • Tampa, Florida, United States, 33612
        • Local Institution - 0008
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Local Institution - 0168
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Local Institution - 0094
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Local Institution - 0171
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Local Institution - 0173
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Local Institution - 0051
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 0004
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Local Institution - 0003
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Local Institution - 0177
    • New York
      • Albany, New York, United States, 12208
        • Local Institution - 0176
      • Buffalo, New York, United States, 14263
        • Local Institution - 0157
      • Mineola, New York, United States, 11501
        • Local Institution - 0007
      • New York, New York, United States, 10021
        • Local Institution - 0001
      • New York, New York, United States, 10029
        • Local Institution - 0006
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7305
        • Local Institution - 0166
      • Durham, North Carolina, United States, 27708
        • Local Institution
    • Oregon
      • Portland, Oregon, United States, 97213
        • Local Institution - 0044
      • Portland, Oregon, United States, 97239
        • Local Institution - 0010
      • Tigard, Oregon, United States, 97223
        • Local Institution - 0180
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution - 0074
      • Pittsburgh, Pennsylvania, United States, 15212
        • Local Institution - 0011
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0040
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Local Institution - 0169
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Local Institution - 0009
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Local Institution - 0234

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
  • Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
  • Must have disease free status as determined by imaging within 4 weeks of dosing
  • Tumor tissue must be provided for biomarker analysis
  • Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy

Exclusion Criteria:

  • Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
  • Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
  • Subjects with active, known or suspected autoimmune disease
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
  • Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
  • Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection

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: Triple

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: Nivolumab
Nivolumab dose as specified
Biological: Nivolumab
Placebo Comparator: Placebo
Placebo dose as specified
Other: Placebo

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
Disease Free Survival (DFS)
Time Frame: approximately up to 48 months
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
approximately up to 48 months
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
Time Frame: approximately up to 48 months
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
approximately up to 48 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
Non-Urothelial Tract Recurrence Free Survival
Time Frame: up to 53 months
The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
up to 53 months
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population
Time Frame: up to 53 months
The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
up to 53 months
Overall Survival
Time Frame: on going
the time from randomization to the date of death from any cause.
on going
Overall Survival in Participants With PD-L1 Expression ≥ 1%
Time Frame: on going
the time from randomization to the date of death from any cause.
on going
Disease Specific Survival
Time Frame: on going
the time from randomization to the date of death due to disease (urothelial cancer).
on going
Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%
Time Frame: on going
the time from randomization to the date of death due to disease (urothelial cancer).
on going

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 22, 2016

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.
July 17, 2020

Study Completion (Actual)

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 19, 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).
December 14, 2015

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.
December 15, 2015

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.
December 16, 2015

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.
July 30, 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.
July 6, 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.
July 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.
  • CA209-274
  • 2022-500630-29-00 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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