A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

April 10, 2026 updated by: Bristol-Myers Squibb

A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

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.
855

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
      • Capital Federal, Buenos Aires, Argentina, 1426
        • Local Institution - 0051
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
        • Local Institution - 0049
    • Distrito Federal
      • Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina, 1118
        • Local Institution - 0151
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Local Institution - 0131
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Local Institution - 0130
      • Macquarie University, New South Wales, Australia, 2109
        • Local Institution - 0157
      • St Leonards, New South Wales, Australia, 2065
        • Local Institution - 0043
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Local Institution - 0143
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0037
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0038
  • Austria
      • Klagenfurt, Austria, 9020
        • Local Institution - 0090
      • Krems, Austria, 3500
        • Local Institution - 0091
      • Linz, Austria, 4020
        • Local Institution - 0011
      • Vienna, Austria, 1090
        • Local Institution - 0012
  • Belgium
      • Brussels, Belgium, 1200
        • Local Institution - 0060
      • Ghent, Belgium, 9000
        • Local Institution - 0063
      • Wilrijk, Belgium, 2610
        • Local Institution - 0062
  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Local Institution - 0164
      • São Paulo, Brazil, 01221-020
        • Local Institution - 0214
    • Ceará
      • Fortaleza, Ceará, Brazil, 60130-241
        • Local Institution - 0094
    • Minas Gerais
      • Ipatinga, Minas Gerais, Brazil, 35160-158
        • Local Institution - 0099
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Local Institution - 0092
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Local Institution - 0212
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610000
        • Local Institution - 0097
    • São Paulo
      • Barretos, São Paulo, Brazil, 14780-070
        • Local Institution - 0098
      • Jaú, São Paulo, Brazil, 17210-080
        • Local Institution - 0095
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Local Institution - 0093
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Local Institution - 0159
    • Ontario
      • North York, Ontario, Canada, M2K 1E1
        • Local Institution - 0182
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Local Institution - 0192
      • Montreal, Quebec, Canada, H3T 1M5
        • Local Institution - 0190
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8330024
        • Local Institution - 0053
      • Santiago, Santiago Metropolitan, Chile, 8380456
        • Local Institution - 0052
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0210
      • Santiago, Santiago Metropolitan, Chile
        • Local Institution - 0054
  • Colombia
      • Bucaramanga, Colombia, 681004
        • Local Institution - 0104
      • Montería, Colombia, 230003
        • Local Institution - 0103
    • Bogota D.C.
      • Colombia, Bogota D.C., Colombia
        • Local Institution - 0201
  • Finland
      • Helsinki, Finland, 00029
        • Local Institution - 0148
      • Tampere, Finland, 33521
        • Local Institution - 0145
      • Turku, Finland, 20251
        • Local Institution - 0146
  • France
      • Amiens, France, 80054
        • Local Institution - 0205
      • Angers, France, 49100
        • Local Institution - 0198
      • Besançon, France, 25000
        • Local Institution - 0101
      • Bordeaux, France, 33076
        • Local Institution - 0217
      • Clermont-Ferrand, France, 63000
        • Local Institution - 0199
      • La Tronche, France, 38043
        • Local Institution - 0206
      • Marseille, France, 13273
        • Local Institution - 0075
      • Montpellier, France, 34298
        • Local Institution - 0200
      • Nice, France, 06189
        • Local Institution - 0074
      • Paris, France, 75014
        • Local Institution - 0163
      • Pierre Benite Cedax, France, 69495
        • Local Institution - 0020
      • Saint-Herblain, France, 44805
        • Local Institution - 0188
      • Strasbourg, France, 67091
        • Local Institution - 0002
      • Toulouse, France, 31059
        • Local Institution - 0003
    • Finistère
      • Brest, Finistère, France, 29609
        • Local Institution - 0202
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • Local Institution - 0204
  • Germany
      • Aachen, Germany, 52074
        • Local Institution - 0078
      • Erfurt, Germany, 99028
        • Local Institution - 0015
      • Essen, Germany, 45136
        • Local Institution - 0081
      • Frankfurt am Main, Germany, 60590
        • Local Institution - 0086
      • Göttingen, Germany, 37075
        • Local Institution - 0080
      • Herne, Germany, 44625
        • Local Institution - 0013
      • Jena, Germany, 07747
        • Local Institution - 0010
      • Lübeck, Germany, 23538
        • Local Institution - 0084
      • Magdeburg, Germany, 39120
        • Local Institution - 0079
      • München, Germany, 81675
        • Local Institution - 0082
      • Nuremberg, Germany, 90419
        • Local Institution - 0016
      • Trier, Germany, 54292
        • Local Institution - 0085
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Local Institution - 0100
  • Greece
      • Chaïdári, Greece, 12462
        • Local Institution - 0194
    • Attikí
      • Athens, Attikí, Greece, 155 62
        • Local Institution - 0195
    • Thessalía
      • Larissa, Thessalía, Greece, 411 10
        • Local Institution - 0031
  • Israel
      • Beersheba, Israel, 84101
        • Local Institution - 0068
      • Haifa, Israel, 3109601
        • Local Institution - 0066
      • Ramat Gan, Israel, 52621
        • Local Institution - 0067
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Local Institution - 0196
  • Italy
      • Bari, Italy, 70124
        • Local Institution - 0064
      • Meldola (FC), Italy, 47014
        • Local Institution - 0193
      • Milan, Italy, 20133
        • Local Institution - 0032
      • Modena, Italy, 41012
        • Local Institution - 0065
      • Padova, Italy, 35128
        • Local Institution - 0033
      • Pisa, Italy, 56126
        • Local Institution - 0034
      • Roma, Italy, 00168
        • Local Institution - 0035
  • Japan
      • Fukuoka, Japan, 812-8582
        • Local Institution - 0174
      • Kyoto, Japan, 606-8507
        • Local Institution - 0180
    • Aichi-ken
      • Komaki, Aichi-ken, Japan, 485-8520
        • Local Institution - 0186
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0030804
        • Local Institution - 0184
      • Sapporo, Hokkaido, Japan, 060-8543
        • Local Institution - 0177
      • Sapporo, Hokkaido, Japan, 0608604
        • Local Institution - 0185
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 3058576
        • Local Institution - 0179
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 761-0793
        • Local Institution - 0171
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 222-0036
        • Local Institution - 0169
    • Niigata
      • Niigata, Niigata, Japan, 9518520
        • Local Institution - 0168
    • Osaka
      • Sayama, Osaka, Japan, 589-8511
        • Local Institution - 0173
      • Takatsuki, Osaka, Japan, 569-8686
        • Local Institution - 0175
    • Saitama
      • Hidaka-shi, Saitama, Japan, 3501298
        • Local Institution - 0176
    • Shizuoka
      • Hamamatasu, Shizuoka, Japan, 431-3192
        • Local Institution - 0170
    • Tokyo
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution - 0178
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Local Institution - 0172
  • Mexico
      • Colima, Mexico, 28017
        • Local Institution - 0105
    • BAJA Californa SUR
      • La Paz, BAJA Californa SUR, Mexico, 23040
        • Local Institution - 0160
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45050
        • Local Institution - 0102
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Local Institution - 0056
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution - 0070
      • Groningen, Netherlands, 9713 GZ
        • Local Institution - 0072
      • Sittard-Geleen, Netherlands, 6162 BG
        • Local Institution - 0073
  • New Zealand
      • Auckland, New Zealand, 1023
        • Local Institution - 0087
      • Christchurch, New Zealand, 8011
        • Local Institution - 0089
  • Norway
      • Grålum, Norway, 1714
        • Local Institution - 0158
      • Lorenskog, Norway, 1478
        • Local Institution - 0132
      • Oslo, Norway, 0379
        • Local Institution - 0133
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Local Institution - 0153
      • Porto, Portugal, 4200-072
        • Local Institution - 0152
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0219
      • Craiova, Romania, 200542
        • Local Institution - 0076
      • Sector 2, Romania, 022328
        • Local Institution - 0058
  • Russia
      • Saint Petersburg, Russia, 197758
        • Local Institution
      • Saint Petersburg, Russia, 194044
        • Local Institution
  • Singapore
      • Singapore, Singapore, 168583
        • Local Institution - 0154
  • South Korea
      • Busan, South Korea, 48108
        • Local Institution - 0220
      • Daegu, South Korea, 41404
        • Local Institution - 0218
      • Gyeongsangnam-do, South Korea, 50612
        • Local Institution - 0208
      • Seongnam-si, South Korea, 13496
        • Local Institution - 0215
      • Seoul, South Korea, 02841
        • Local Institution - 0140
      • Seoul, South Korea, 03080
        • Local Institution - 0136
      • Seoul, South Korea, 05505
        • Local Institution - 0211
      • Seoul, South Korea, 06351
        • Local Institution - 0138
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • Local Institution - 0137
    • Kyǒnggi-do
      • Seongnam-si, Kyǒnggi-do, South Korea, 13620
        • Local Institution - 0203
  • Spain
      • Lugo, Spain, 27003
        • Local Institution - 0113
      • Madrid, Spain, 28007
        • Local Institution - 0111
      • Madrid, Spain, 28033
        • Local Institution - 0112
      • Madrid, Spain, 28041
        • Local Institution - 0114
      • Málaga, Spain, 29010
        • Local Institution - 0156
      • Seville, Spain, 41013
        • Local Institution - 0109
  • Taiwan
      • Kaohsiung City, Taiwan, 833401
        • Local Institution - 0135
      • Taichung, Taiwan, 407219
        • Local Institution - 0165
      • Taipei, Taiwan, 11217
        • Local Institution - 0139
      • Taipei, Taiwan, 100229
        • Local Institution - 0141
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Local Institution - 0122
      • Lancaster, United Kingdom, LA1 4RP
        • Local Institution - 0117
      • London, United Kingdom, SE1 9RT
        • Local Institution - 0121
      • Oxford, United Kingdom, OX3 7LE
        • Local Institution - 0124
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • Local Institution - 0128
    • Yorkshire
      • York, Yorkshire, United Kingdom, YO31 8HE
        • Local Institution - 0127
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Local Institution - 0022
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center
    • Colorado
      • Littleton, Colorado, United States, 80120-4413
        • Local Institution - 0021
    • Florida
      • Pensacola, Florida, United States, 32503
        • Local Institution - 0036
      • Tampa, Florida, United States, 33612
        • Local Institution - 0004
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 0144
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Local Institution - 0005
      • Peoria, Illinois, United States, 61615
        • Local Institution - 0006
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Local Institution - 0181
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0009
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0166
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0209
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Local Institution - 0025
      • Minneapolis, Minnesota, United States, 55455
        • Local Institution - 0129
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Local Institution - 0183
      • Omaha, Nebraska, United States, 68198-6840
        • Local Institution - 0001
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Local Institution - 0024
    • New York
      • Albany, New York, United States, 12208
        • Local Institution - 0029
      • Lake Success, New York, United States, 11042
        • Local Institution - 0069
      • New York, New York, United States, 10065
        • Local Institution - 0047
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0191
    • Oregon
      • Tigard, Oregon, United States, 97223
        • Local Institution - 0028
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution - 0189
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Local Institution - 0007
    • Texas
      • Austin, Texas, United States, 78731
        • Local Institution - 0030
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Local Institution - 0023

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:

  • Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion Criteria:

  • Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
  • Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted

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.
Active Comparator: Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy
Drug: Cisplatin
Specified dose on specified days
Other Names:
  • Chemotherapy
Drug: Gemcitabine
Specified dose on specified days
Other Names:
  • Chemotherapy
Experimental: Arm B: Nivolumab + GC Chemotherapy
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Cisplatin
Specified dose on specified days
Other Names:
  • Chemotherapy
Drug: Gemcitabine
Specified dose on specified days
Other Names:
  • Chemotherapy

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
Pathological Complete Response (pCR) rate, in all randomized participants
Time Frame: Approximately 43 months
Arm B vs. Arm A
Approximately 43 months
Event-Free Survival (EFS), in all randomized participants
Time Frame: Approximately 36 months
Arm B vs. Arm A
Approximately 36 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
Time Frame: Approximately 60 months
Arm B vs. Arm A
Approximately 60 months
Incidence of Adverse Events (AE) in participants who received at least one treatment dose
Time Frame: Approximately 60 months
Approximately 60 months
Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose
Time Frame: Approximately 60 months
Approximately 60 months
Incidence of deaths in participants who received at least one treatment dose
Time Frame: Approximately 60 months
Approximately 60 months
Incidence of laboratory abnormalities in participants who received at least one treatment dose
Time Frame: Approximately 60 months
Approximately 60 months
pCR rate, descriptively in all concurrently randomized participants
Time Frame: Approximately 43 months
Arm C vs. Arm B and Arm A
Approximately 43 months
OS, descriptively in all concurrently randomized participants
Time Frame: Approximately 60 months
Arm C vs. Arm B and Arm A
Approximately 60 months
EFS, descriptively in all concurrently randomized participants
Time Frame: Approximately 36 months
Arm C vs. Arm B and Arm A
Approximately 36 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.
November 6, 2018

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.
February 16, 2026

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.
December 30, 2027

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).
September 5, 2018

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.
September 5, 2018

First Posted (Actual)

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.
September 7, 2018

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.
April 15, 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.
April 10, 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.
April 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.
  • CA017-078
  • 2024-512158-12 (Other Identifier: EU CT Number)

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

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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