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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

StatusCompleted
PhasePhase 3
Started2018-11-06
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 72 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-08
Study Status, References v71
Trial completed
Study completion confirmed: April 2026 (last estimated December 2027)
Completion dateestimated 2027-12-30→confirmed 2026-04-14
2026-04-10
Study Status, IPDSharing v70
Re-verified, no change to tracked fields
2026-01-30
Study Status v69
Primary completion date2025-11-17→2026-02-16
2025-05-27
Study Identification, Study Status, Study Design, Outcome Measures, Contacts/Locations, References v68
Primary completion date2025-04-04→2025-11-17
Enrollment target861→855
Secondary endpointsdetails revised at 1 of 8 entries
Study sitesdetails revised at 3 of 172 sites
2024-01-29
Study Status, Study Design, Contacts/Locations, References v67
Primary completion date2023-11-03→2025-04-04
Study sites173→172
Show 45 earlier versions
2023-01-25
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v66
Trial statusRecruiting→Active, Not Recruiting
Study sites194→173
2022-11-03
Study Status, Contacts/Locations v65
Primary completion date2024-01-27→2023-11-03
Completion date2025-01-15→2027-12-30
Study sites194 entries, revised
Instituto Medico Especializado Alexander Fleming Local Institution - 0051 Instituto do Cancer Arnaldo Vieira de Carvalho0214 Local Institution - 0152
2022-06-28
Study Status, Contacts/Locations v64
Study sites194 entries, revised
UniversityLocal ofInstitution Minnesota- 0129 Local Institution - 0131 Local Institution CHU Amiens - Picardie Institut Bergonie Hopital Prive CLAIRVAL Helios Klinikum Erfurt Universitaetsklinikum Magdeburg Universitaetsmedizin Der Johannes Gutenberg-Universitaet0159 Local Institution - 0205 Local Institution - 0217 Local Institution - 0075 Local Institution - 0015 Local Institution - 0079 Local Institution - 0100 Local Institution - 0184 Local Institution - 0185 Local Institution - 0179 Local Institution - 0102 Local Institution - 0153 Local Institution - 0141 Local Institution - 0128 Local I [...]
2022-06-15
Study Status, Contacts/Locations v63
Primary completion date2024-04-25→2024-01-27
Study sites194 entries, revised
The University Ofof Chicago Northwell Health HospitalMedical Aleman Macquarie University Calvary Hospital Austin Hospital Klinikum Klagenfurt Am Woerthersee Krankenhaus der Elisabethinen Linz GmbH AKH Allgemeines Krankenhaus WienCenter Local Institution Oncocentro Servico Medicos e Hospitalares Ltda Hospital Marcio Cunha ONCOSITE - Centro de Pesquisa Clinica em Oncologia Fundacao Pio Xii Hosp Cancer De Barretos Fundacao Doutor Amaral Carvalho Hospital De Base Da Faculdade De Medicina De Rio Preto Inca - Instituto Nacional Do Cancer0069 Local Institution - 0151 Local Institution Pontificia Univ [...] [...]
2022-05-05
Study Status, Outcome Measures, Contacts/Locations, References v62
Primary completion date2024-01-14→2024-04-25
Secondary endpoints5 to 8 entries
pCR rate, descriptively in all concurrently randomized participants EFS, descriptively in all concurrently randomized participants OS, descriptively in all concurrently randomized participants
Study sites194 entries, revised
H.Local LeeInstitution Moffitt- Cancer Center Instituto Medico Especializado Alexander Fleming Hospital Britanico De Buenos Aires Northern Cancer Institute St John of God Murdoch Hospital Universitaetsklinikum Krems0004 Local Institution Hospital Moinhos- de Vento Hospital Sao Lucas Da Pucrs0051 Local Institution Hospital Clinico- de la Universidad De Chile Bradfordhill Fundacion Arturo Lopez Perez0049 Local Institution Oncomedica S.A. Hopital- Morvan Chu Jean Minjoz Chu Henri Mondor CHU Michallon Institut du Cancer de Montpellier Centre Antoine Lacassagne Institut Mutualiste Montsouris Centre [...] [...]
2022-03-17
Study Status, Contacts/Locations v61
Study sites194 entries, revised
CentroInstituto do Cancer Arnaldo Vieira de Investigacion Clinica Bradford HillCarvalho Local InstitutionBradfordhill
2022-03-02
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v60
Primary completion date2024-04-24→2024-01-14
Enrollment target976→861
Study arms3→2
InterventionsBMS-986205 (Drug), BMS-986205 Placebo (Drug), Cisplatin (Drug), Gemcitabine (Drug), Nivolumab (Biological)→Cisplatin (Drug), Gemcitabine (Drug), Nivolumab (Biological)
Eligibility criteria-375 characters
Inclusion Criteria: Participants with MIBC, clinical stage T2-T4a, N0 (<10 mm on CT or MRI), M0, diagnosed at TURBT and confirmed by radiographic imaging. Variant histology is acceptable if there is a predominant urothelial component. Participant must be deemed eligible for Radial Cystectomy (R [...] us 0 or 1 Exclusion Criteria: Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer Prior [...] radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted Ineligible to receive c [...]
Secondary endpoints7 to 5 entries
Incidence of Adverse Events (AE) in allparticipants treatedwho participantsreceived at least one treatment dose Incidence of Serious Adverse Events (SAE) in allparticipants treatedwho participantsreceived at least one treatment dose Incidence of Laboratorydeaths in participants who received at least one treatment dose Incidence of laboratory abnormalities in allparticipants treatedwho participants Incidencereceived ofat deathleast inone alltreatment treated participants Pathological Complete Response (pCR) rate, in all randomized participants Event Free Survival (EFS), in all randomized partic [...] [...]
Study sitescontacts updated at 2 of 194 sites
Study title+79 characters
A Study ofto ChemoCompare OnlyChemotherapy Alone Versus ChemoChemotherapy Plus Nivo WithNivolumab or WithoutNivolumab and BMS-986205, Followed by Post-Continued Therapy After Surgery Therapy With NivoNivolumab or NivoNivolumab and BMS-986205 in PatientsParticipants With MIBCMuscle Invasive Bladder Cancer
2022-01-04
Study Status, Contacts/Locations v59
Study sitesdetails revised at 1 of 194 sites
2021-12-14
Study Status, Sponsor/Collaborators, Study Design, Contacts/Locations, References v58
Primary completion date2023-11-28→2024-04-24
Completion date2026-12-30→2025-01-15
Start date2018-10-12→2018-11-06
Enrollment target1200→976
Study sites194 entries, revised
LocalUc InstitutionIrvine Health Northern Cancer instituteInstitute AssociacaoONCOSITE Hospital- Centro de CaridadePesquisa IjuiClinica em Oncologia
Collaborators+28 characters
Ono Pharmaceutical Co., Ltd.
2021-08-23
Study Status, Contacts/Locations v57
Study sites194 entries, revised
LocalHospital InstitutionMoinhos de Vento LocalInca Institution- Instituto Nacional Do Cancer
2021-07-29
Study Status, Contacts/Locations v56
Study sitesdetails revised at 3 of 194 sites
2021-07-23
Study Status, Contacts/Locations v55
Study sites193→194
2021-07-09
Study Status, Contacts/Locations v54
Study sites186→193
2020-10-09
Study Status, Contacts/Locations v53
Study sitesdetails revised at 2 of 186 sites
2020-09-25
Study Status, Contacts/Locations v52
Study sites186 entries, revised
LocalChu InstitutionHenri Mondor
2020-08-26
Study Status, Contacts/Locations v51
Study sites186 entries, revised
LocalICANS-Institut Institutionde cancerologie Strasbourg Europe
2020-08-07
Study Status, Contacts/Locations v50
Study sites186 entries, revised
LocalMacquarie InstitutionUniversity LocalNorthern InstitutionCancer institute LocalAustin InstitutionHospital LocalSt InstitutionJohn of God Murdoch Hospital
2020-07-28
Study Status, Contacts/Locations v49
Study sites186 entries, revised
LocalHopital InstitutionPrive CLAIRVAL
2020-07-13
Study Status, Contacts/Locations v48
Study sites185→186
2020-06-26
Study Status, Contacts/Locations v47
Study sitesdetails revised at 1 of 185 sites
2020-06-19
Study Status, Contacts/Locations v46
Study sites185 entries, revised
LocalCentre InstitutionRene Gauducheau LocalSf. InstitutionNectarie Oncology Center
2020-06-15
Study Status, Contacts/Locations v45
Study sites184→185
2020-06-09
Study Status, Contacts/Locations v44
Study sites184 entries, revised
LocalInstitut InstitutionClaudius Regaud
2020-06-02
Study Status, Contacts/Locations v43
Study sites183→184
2020-05-21
Study Status v42
Re-verified, no change to tracked fields
2020-05-20
Study Status, Contacts/Locations v41
Study sitesdetails revised at 6 of 183 sites
2020-05-15
Study Status, Contacts/Locations v40
Study sites182→183
2020-04-24
Study Status, Contacts/Locations v39
Study sites181→182
2020-03-16
Study Status, Contacts/Locations v38
Study sites180→181
2020-03-05
Study Status, Contacts/Locations v37
Study sites178→180
2020-02-28
Study Status, Contacts/Locations v36
Study sites177→178
2020-02-21
Study Status, Contacts/Locations v35
Study sites175→177
2020-02-04
Study Status, Contacts/Locations v34
Study sites174→175
2020-01-29
Study Status, Contacts/Locations v33
Study sites173→174
2020-01-24
Study Status, Contacts/Locations v32
Study sites173 entries, revised
LocalCleveland InstitutionClinic Taussig Cancer Center
2020-01-16
Study Status, Contacts/Locations v31
Study sites172→173
2019-12-23
Study Status, Contacts/Locations v30
Study sites171→172
2019-12-10
Study Status, Contacts/Locations v29
Study sites171 entries, revised
LocalIRCCS InstitutionGiovanni Paolo II Istituto Oncologico
2019-12-04
Study Status, Contacts/Locations v28
Study sites171 entries, revised
LocalUniversitaetsklinikum InstitutionMagdeburg LocalInstitute InstitutionOf Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha
2019-11-26
Study Status, Contacts/Locations v27
Study sites171 entries, revised
LocalHospital InstitutionAleman
2019-11-25
Study Status, Contacts/Locations v26
Study sitesdetails revised at 1 of 171 sites
2019-11-20
Study Status, Contacts/Locations v25
Study sites171 entries, revised
LocalOncology InstitutionHematology West P.C. dba Nebraska Cancer Specialists LocalKrankenhaus Institutionder Barmherzigen Brueder
2019-11-15
Study Status, Contacts/Locations v24
Study sitesdetails revised at 14 of 171 sites
2019-11-12
Study Status, Contacts/Locations v23
Study sites170→171
2019-11-05
Study Status, Contacts/Locations v22
Study sites170 entries, revised
LocalUniversitaetsklinikum InstitutionKrems
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).
Trial Details
NCT Number NCT03661320
Lead Sponsor Bristol-Myers Squibb
Collaborators: Ono Pharmaceutical Co., Ltd.
Conditions Urinary Bladder Neoplasms, Muscle-Invasive Bladder Cancer
Enrollment 855 participants
Start Date 2018-11-06
Primary Completion 2026-02-16 (estimated)
Study Completion 2026-04-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-10