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
- Diseases
- Bladder cancer
- 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
Sites (166)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0051 Coordinator of this site? Confirm its status | Capital Federal | Argentina | Unknown status |
| Local Institution - 0151 Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Unknown status |
| Local Institution - 0049 Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| Landeskrankenanstalten-Betriebsgesellschaft Kabeg Coordinator of this site? Confirm its status | Klagenfurt Am Woerthersee | Austria | Completed |
| Universitaetsklinikum Krems Coordinator of this site? Confirm its status | Krems An Der Donau | Austria | Completed |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Completed |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Local Institution - 0131 Coordinator of this site? Confirm its status | Garran | Australia | Unknown status |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Local Institution - 0130 Coordinator of this site? Confirm its status | Kingswood | Australia | Unknown status |
| Local Institution - 0157 Coordinator of this site? Confirm its status | Macquarie University | Australia | Unknown status |
| Local Institution - 0038 Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Local Institution - 0143 Coordinator of this site? Confirm its status | North Adelaide | Australia | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| GasthuisZusters Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Completed |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Local Institution - 0098 Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Local Institution - 0094 Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Local Institution - 0092 Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Local Institution - 0099 Coordinator of this site? Confirm its status | Ipatinga | Brazil | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Jaú | Brazil | Unknown status |
| Local Institution - 0212 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Local Institution - 0097 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Local Institution - 0164 Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Local Institution - 0214 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0192 Coordinator of this site? Confirm its status | Chicoutimi | Canada | Unknown status |
| Local Institution - 0159 Coordinator of this site? Confirm its status | Kelowna | Canada | Unknown status |
| Local Institution - 0190 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0182 Coordinator of this site? Confirm its status | North York | Canada | Unknown status |
| Local Institution - 0210 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0054 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0053 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0104 Coordinator of this site? Confirm its status | Bucaramanga | Colombia | Unknown status |
| Local Institution - 0201 Coordinator of this site? Confirm its status | Colombia | Colombia | Unknown status |
| Local Institution - 0103 Coordinator of this site? Confirm its status | Montería | Colombia | Unknown status |
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Completed |
| HELIOS Klinikum Erfurt GmbH Coordinator of this site? Confirm its status | Erfurt | Germany | Completed |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Completed |
| St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Coordinator of this site? Confirm its status | Herne | Germany | Completed |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Completed |
| Otto Von Guericke Universitaet Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Completed |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Klinikum rechts der Isar der TU Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Klinikum Nuernberg Coordinator of this site? Confirm its status | Nuremberg | Germany | Completed |
| Barmherzige Brueder Trier gGmbH Coordinator of this site? Confirm its status | Trier | Germany | Completed |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Completed |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Completed |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Completed |
| Besancon University Hospital Center Coordinator of this site? Confirm its status | Besancon Cedex | France | Completed |
| Centre Hospitalier Regional Et Universitaire De Brest Coordinator of this site? Confirm its status | Brest Cedex 2 | France | Completed |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Completed |
| Hôpital Privé Clairval Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Completed |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Completed |
| Institut Mutualiste Montsouris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Completed |
| Institut Universitaire Du Cancer Toulouse-Oncopole Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| Local Institution - 0128 Coordinator of this site? Confirm its status | Chelmsford | United Kingdom | Unknown status |
| Local Institution - 0122 Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Local Institution - 0117 Coordinator of this site? Confirm its status | Lancaster | United Kingdom | Unknown status |
| Local Institution - 0121 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0124 Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | York | United Kingdom | Unknown status |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Completed |
| Local Institution - 0068 Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Local Institution - 0066 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Local Institution - 0067 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Local Institution - 0196 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Istituto Tumori Bari Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Completed |
| AUSL Modena - Ospedale B. Ramazzini Coordinator of this site? Confirm its status | Carpi | Italy | Completed |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Completed |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Local Institution - 0174 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Local Institution - 0170 Coordinator of this site? Confirm its status | Hamamatasu | Japan | Unknown status |
| Local Institution - 0176 Coordinator of this site? Confirm its status | Hidaka-shi | Japan | Unknown status |
| Local Institution - 0171 Coordinator of this site? Confirm its status | Kita-gun | Japan | Unknown status |
| Local Institution - 0186 Coordinator of this site? Confirm its status | Komaki | Japan | Unknown status |
| Local Institution - 0180 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Local Institution - 0178 Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Local Institution - 0168 Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Local Institution - 0177 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0185 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0184 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0173 Coordinator of this site? Confirm its status | Sayama | Japan | Unknown status |
| Local Institution - 0172 Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Local Institution - 0175 Coordinator of this site? Confirm its status | Takatsuki | Japan | Unknown status |
| Local Institution - 0179 Coordinator of this site? Confirm its status | Tsukuba | Japan | Unknown status |
| Local Institution - 0169 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0220 Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Local Institution - 0218 Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Local Institution - 0137 Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Local Institution - 0208 Coordinator of this site? Confirm its status | Gyeongsangnam-do | South Korea | Unknown status |
| Local Institution - 0215 Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Local Institution - 0203 Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Local Institution - 0211 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0140 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0136 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0138 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0105 Coordinator of this site? Confirm its status | Colima | Mexico | Unknown status |
| Local Institution - 0160 Coordinator of this site? Confirm its status | La Paz | Mexico | Unknown status |
| Local Institution - 0056 Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Local Institution - 0102 Coordinator of this site? Confirm its status | Zapopan | Mexico | Unknown status |
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Sykehuset Oestfold HF Kalnes Coordinator of this site? Confirm its status | Graalum | Norway | Completed |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Completed |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Completed |
| Local Institution - 0087 Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Local Institution - 0089 Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Local Institution - 0153 Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Local Institution - 0152 Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Local Institution Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Local Institution - 0154 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0135 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Local Institution - 0165 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Local Institution - 0139 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0141 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Local Institution - 0144 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Local Institution - 0166 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0009 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0209 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0189 Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Local Institution - 0191 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 0181 Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Local Institution - 0069 Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Local Institution - 0024 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Local Institution - 0021 Coordinator of this site? Confirm its status | Littleton | United States | Unknown status |
| Local Institution - 0025 Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Local Institution - 0129 Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Local Institution - 0047 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 0023 Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Local Institution - 0183 Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Local Institution - 0036 Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Local Institution - 0006 Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| UC Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Local Institution - 0004 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Tigard | United States | Unknown status |
| Local Institution - 0022 Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.