Sign in

NCT03661320CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
855 (actual)
First submitted
5 Sept 2018
Start date
6 Nov 2018
Primary completion date
16 Feb 2026
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT03661320
EU CT number
2024-512158-12-00
EudraCT number
2017-004692-31

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 855
  • From 6 Nov 2018 to the primary completion date, 16 Feb 2026
  • 166 sites in 28 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (166)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 0051
Coordinator of this site? Confirm its status
Capital FederalArgentinaUnknown status
Local Institution - 0151
Coordinator of this site? Confirm its status
Ciudad Autonoma Buenos AiresArgentinaUnknown status
Local Institution - 0049
Coordinator of this site? Confirm its status
Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Coordinator of this site? Confirm its status
Klagenfurt Am WoertherseeAustriaCompleted
Universitaetsklinikum Krems
Coordinator of this site? Confirm its status
Krems An Der DonauAustriaCompleted
Ordensklinikum Linz GmbH
Coordinator of this site? Confirm its status
LinzAustriaCompleted
Medical University of Vienna
Coordinator of this site? Confirm its status
ViennaAustriaCompleted
Local Institution - 0131
Coordinator of this site? Confirm its status
GarranAustraliaUnknown status
Local Institution - 0037
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
Local Institution - 0130
Coordinator of this site? Confirm its status
KingswoodAustraliaUnknown status
Local Institution - 0157
Coordinator of this site? Confirm its status
Macquarie UniversityAustraliaUnknown status
Local Institution - 0038
Coordinator of this site? Confirm its status
MurdochAustraliaUnknown status
Local Institution - 0143
Coordinator of this site? Confirm its status
North AdelaideAustraliaUnknown status
Local Institution - 0043
Coordinator of this site? Confirm its status
St LeonardsAustraliaUnknown status
GasthuisZusters Antwerpen
Coordinator of this site? Confirm its status
AntwerpBelgiumCompleted
Az Maria Middelares Gent
Coordinator of this site? Confirm its status
GentBelgiumCompleted
Cliniques Universitaires Saint-Luc
Coordinator of this site? Confirm its status
Sint-Lambrechts-WoluweBelgiumCompleted
Local Institution - 0098
Coordinator of this site? Confirm its status
BarretosBrazilUnknown status
Local Institution - 0094
Coordinator of this site? Confirm its status
FortalezaBrazilUnknown status
Local Institution - 0092
Coordinator of this site? Confirm its status
IjuíBrazilUnknown status
Local Institution - 0099
Coordinator of this site? Confirm its status
IpatingaBrazilUnknown status
Local Institution - 0095
Coordinator of this site? Confirm its status
JaúBrazilUnknown status
Local Institution - 0212
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Local Institution - 0097
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Local Institution - 0164
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown status
Local Institution - 0093
Coordinator of this site? Confirm its status
São José do Rio PretoBrazilUnknown status
Local Institution - 0214
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Local Institution - 0192
Coordinator of this site? Confirm its status
ChicoutimiCanadaUnknown status
Local Institution - 0159
Coordinator of this site? Confirm its status
KelownaCanadaUnknown status
Local Institution - 0190
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Local Institution - 0182
Coordinator of this site? Confirm its status
North YorkCanadaUnknown status
Local Institution - 0210
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Local Institution - 0052
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Local Institution - 0054
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Local Institution - 0053
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Local Institution - 0104
Coordinator of this site? Confirm its status
BucaramangaColombiaUnknown status
Local Institution - 0201
Coordinator of this site? Confirm its status
ColombiaColombiaUnknown status
Local Institution - 0103
Coordinator of this site? Confirm its status
MonteríaColombiaUnknown status
Universitaetsklinikum Aachen AöR
Coordinator of this site? Confirm its status
AachenGermanyCompleted
HELIOS Klinikum Erfurt GmbH
Coordinator of this site? Confirm its status
ErfurtGermanyCompleted
KEM I Evang. Kliniken Essen-Mitte gGmbH
Coordinator of this site? Confirm its status
EssenGermanyCompleted
Goethe University Frankfurt
Coordinator of this site? Confirm its status
Frankfurt Am MainGermanyCompleted
Universitaetsmedizin Goettingen
Coordinator of this site? Confirm its status
GoettingenGermanyCompleted
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Coordinator of this site? Confirm its status
HerneGermanyCompleted
Universitaetsklinikum Jena KöR
Coordinator of this site? Confirm its status
JenaGermanyCompleted
Universitaetsklinikum Schleswig-Holstein AöR
Coordinator of this site? Confirm its status
LuebeckGermanyCompleted
Otto Von Guericke Universitaet Magdeburg
Coordinator of this site? Confirm its status
MagdeburgGermanyCompleted
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Coordinator of this site? Confirm its status
MainzGermanyCompleted
Klinikum rechts der Isar der TU Muenchen AöR
Coordinator of this site? Confirm its status
MunichGermanyCompleted
Klinikum Nuernberg
Coordinator of this site? Confirm its status
NurembergGermanyCompleted
Barmherzige Brueder Trier gGmbH
Coordinator of this site? Confirm its status
TrierGermanyCompleted
Hospital Universitario Lucus Augusti
Coordinator of this site? Confirm its status
LugoSpainCompleted
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainCompleted
MD Anderson Cancer Center
Coordinator of this site? Confirm its status
MadridSpainCompleted
Hospital General Universitario Gregorio Marañón
Coordinator of this site? Confirm its status
MadridSpainCompleted
Hospital Universitario Virgen de la Victoria
Coordinator of this site? Confirm its status
MálagaSpainCompleted
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainCompleted
HUS-Yhtymae
Coordinator of this site? Confirm its status
HelsinkiFinlandCompleted
Tampere University Hospital
Coordinator of this site? Confirm its status
TampereFinlandCompleted
Centre Hospitalier Universitaire D'Angers
Coordinator of this site? Confirm its status
AngersFranceCompleted
Besancon University Hospital Center
Coordinator of this site? Confirm its status
Besancon CedexFranceCompleted
Centre Hospitalier Regional Et Universitaire De Brest
Coordinator of this site? Confirm its status
Brest Cedex 2FranceCompleted
Centre Jean Perrin
Coordinator of this site? Confirm its status
Clermont-FerrandFranceCompleted
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Creteil CedexFranceCompleted
Centre Hospitalier Universitaire Grenoble Alpes
Coordinator of this site? Confirm its status
Grenoble Cedex 9FranceCompleted
Hôpital Privé Clairval
Coordinator of this site? Confirm its status
MarseilleFranceCompleted
Institut Regional Du Cancer De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceCompleted
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
NantesFranceCompleted
Centre Antoine Lacassagne
Coordinator of this site? Confirm its status
Nice Cedex 2FranceCompleted
Institut Mutualiste Montsouris
Coordinator of this site? Confirm its status
ParisFranceCompleted
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
Pierre-BéniteFranceCompleted
Institut de Cancérologie Strasbourg Europe
Coordinator of this site? Confirm its status
StrasbourgFranceCompleted
Les Hopitaux Universitaires De Strasbourg
Coordinator of this site? Confirm its status
Strasbourg Cedex 2FranceCompleted
Institut Universitaire Du Cancer Toulouse-Oncopole
Coordinator of this site? Confirm its status
Toulouse Cedex 9FranceCompleted
Local Institution - 0128
Coordinator of this site? Confirm its status
ChelmsfordUnited KingdomUnknown status
Local Institution - 0122
Coordinator of this site? Confirm its status
GlasgowUnited KingdomUnknown status
Local Institution - 0117
Coordinator of this site? Confirm its status
LancasterUnited KingdomUnknown status
Local Institution - 0121
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Local Institution - 0124
Coordinator of this site? Confirm its status
OxfordUnited KingdomUnknown status
Local Institution - 0127
Coordinator of this site? Confirm its status
YorkUnited KingdomUnknown status
University General Hospital Attikon
Coordinator of this site? Confirm its status
AthensGreeceCompleted
General University Hospital of Larissa
Coordinator of this site? Confirm its status
LarissaGreeceCompleted
Local Institution - 0068
Coordinator of this site? Confirm its status
BeershebaIsraelUnknown status
Local Institution - 0066
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Local Institution - 0067
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status
Local Institution - 0196
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Istituto Tumori Bari Giovanni Paolo II
Coordinator of this site? Confirm its status
BariItalyCompleted
AUSL Modena - Ospedale B. Ramazzini
Coordinator of this site? Confirm its status
CarpiItalyCompleted
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
Coordinator of this site? Confirm its status
MeldolaItalyCompleted
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyCompleted
Istituto Oncologico Veneto
Coordinator of this site? Confirm its status
PadovaItalyCompleted
Azienda Ospedaliero Universitaria Pisana
Coordinator of this site? Confirm its status
PisaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyCompleted
Local Institution - 0174
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
Local Institution - 0170
Coordinator of this site? Confirm its status
HamamatasuJapanUnknown status
Local Institution - 0176
Coordinator of this site? Confirm its status
Hidaka-shiJapanUnknown status
Local Institution - 0171
Coordinator of this site? Confirm its status
Kita-gunJapanUnknown status
Local Institution - 0186
Coordinator of this site? Confirm its status
KomakiJapanUnknown status
Local Institution - 0180
Coordinator of this site? Confirm its status
KyotoJapanUnknown status
Local Institution - 0178
Coordinator of this site? Confirm its status
Minato-kuJapanUnknown status
Local Institution - 0168
Coordinator of this site? Confirm its status
NiigataJapanUnknown status
Local Institution - 0177
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Local Institution - 0185
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Local Institution - 0184
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Local Institution - 0173
Coordinator of this site? Confirm its status
SayamaJapanUnknown status
Local Institution - 0172
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Local Institution - 0175
Coordinator of this site? Confirm its status
TakatsukiJapanUnknown status
Local Institution - 0179
Coordinator of this site? Confirm its status
TsukubaJapanUnknown status
Local Institution - 0169
Coordinator of this site? Confirm its status
YokohamaJapanUnknown status
Local Institution - 0220
Coordinator of this site? Confirm its status
BusanSouth KoreaUnknown status
Local Institution - 0218
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
Local Institution - 0137
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaUnknown status
Local Institution - 0208
Coordinator of this site? Confirm its status
Gyeongsangnam-doSouth KoreaUnknown status
Local Institution - 0215
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaUnknown status
Local Institution - 0203
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaUnknown status
Local Institution - 0211
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0140
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0136
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0138
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0105
Coordinator of this site? Confirm its status
ColimaMexicoUnknown status
Local Institution - 0160
Coordinator of this site? Confirm its status
La PazMexicoUnknown status
Local Institution - 0056
Coordinator of this site? Confirm its status
MonterreyMexicoUnknown status
Local Institution - 0102
Coordinator of this site? Confirm its status
ZapopanMexicoUnknown status
Netherlands Cancer Institute
Coordinator of this site? Confirm its status
AmsterdamNetherlandsCompleted
Sykehuset Oestfold HF Kalnes
Coordinator of this site? Confirm its status
GraalumNorwayCompleted
Akershus University Hospital
Coordinator of this site? Confirm its status
LoerenskogNorwayCompleted
Oslo University Hospital HF
Coordinator of this site? Confirm its status
OsloNorwayCompleted
Local Institution - 0087
Coordinator of this site? Confirm its status
AucklandNew ZealandUnknown status
Local Institution - 0089
Coordinator of this site? Confirm its status
ChristchurchNew ZealandUnknown status
Local Institution - 0153
Coordinator of this site? Confirm its status
LisbonPortugalUnknown status
Local Institution - 0152
Coordinator of this site? Confirm its status
PortoPortugalUnknown status
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Coordinator of this site? Confirm its status
BucharestRomaniaCompleted
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Coordinator of this site? Confirm its status
Cluj-NapocaRomaniaCompleted
Centrul De Oncologie SF Nectarie S.R.L.
Coordinator of this site? Confirm its status
CraiovaRomaniaCompleted
Local Institution
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Local Institution - 0154
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
Local Institution - 0135
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanUnknown status
Local Institution - 0165
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
Local Institution - 0139
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Local Institution - 0141
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Local Institution - 0029
Coordinator of this site? Confirm its status
AlbanyUnited StatesUnknown status
Local Institution - 0144
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Local Institution - 0030
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Local Institution - 0166
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Local Institution - 0009
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Local Institution - 0209
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Local Institution - 0189
Coordinator of this site? Confirm its status
CharlestonUnited StatesUnknown status
Local Institution - 0005
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Local Institution - 0191
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Local Institution - 0181
Coordinator of this site? Confirm its status
ColumbiaUnited StatesUnknown status
Local Institution - 0069
Coordinator of this site? Confirm its status
Lake SuccessUnited StatesUnknown status
Local Institution - 0024
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status
Local Institution - 0021
Coordinator of this site? Confirm its status
LittletonUnited StatesUnknown status
Local Institution - 0025
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Local Institution - 0129
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Local Institution - 0007
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Local Institution - 0047
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Local Institution - 0023
Coordinator of this site? Confirm its status
NorfolkUnited StatesUnknown status
Local Institution - 0001
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
Local Institution - 0183
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
Local Institution - 0036
Coordinator of this site? Confirm its status
PensacolaUnited StatesUnknown status
Local Institution - 0006
Coordinator of this site? Confirm its status
PeoriaUnited StatesUnknown status
UC Davis Comprehensive Cancer Center
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status
Local Institution - 0004
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Local Institution - 0028
Coordinator of this site? Confirm its status
TigardUnited StatesUnknown status
Local Institution - 0022
Coordinator of this site? Confirm its status
TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.