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BRIEF TITLE: 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

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


  • Org Study ID: CA017-078
  • Secondary ID: 2017-004692-31
  • NCT ID: NCT03661320
  • NCT Alias:
  • Sponsor: Bristol-Myers Squibb - Industry
  • Source: Bristol-Myers Squibb

Description

To learn more about this study, visit: https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT03661320.html?cid=v_597934

Brief Summary

A study to evaluate nivolumab + chemotherapy or nivolumab/ BMS-986205 + chemotherapy followed by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer (MIBC)

Overal Status Start Date Phase Study Type
Recruiting October 12, 2018 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Pathological Complete Response (pCR) rate, in all randomized participants

Primary Outcome 1 - Time Frame: Approx. 39 months

Primary Outcome 2 - Measure: Event-Free Survival (EFS), in all randomized participants

Primary Outcome 2 - Time Frame: Approx. 57 months

Condition:

  • Bladder Cancer
  • Muscle-Invasive Bladder Cancer
  • BMS-986205

Eligibility

Criteria:
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 (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 LN (≥ 10 mm in short axis) or metastatic bladder cancer

- Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than
TURBT or biopsies is also not permitted

- Ineligible to receive cisplatin due to Grade 2 or higher peripheral neuropathy or
audiometric hearing loss, or calculated (Cockcroft-Gault formula) GFR or measured
(24-hour urine) creatinine clearance (CrCl) < 50 mL/min
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information

Phone: please email:

Email: Clinical.Trials@bms.com

Link: BMS Clinical Trial Information

Locations

Facility Status Contact
Local Institution
Mobile, Alabama 36608
United States
Not yet recruiting Site 0026

Local Institution
Chandler, Arizona 85224
United States
Not yet recruiting Site 0149

Arizona Oncology Associates
Tucson, Arizona 85711
United States
Recruiting Christopher Di Simone, Site 0022

Local Institution
Irvine, California 92868
United States
Not yet recruiting Site 0055

Local Institution
La Jolla, California 92093-0987
United States
Not yet recruiting Site 0077

Local Institution
Sacramento, California 95817
United States
Not yet recruiting Site 0048

Local Institution
San Jose, California 95124
United States
Not yet recruiting Site 0167

Rocky Mountain Cancer Centers Llp
Littleton, Colorado 80120-4413
United States
Recruiting Manojkumar Bupathi, Site 0021

Local Institution
New Haven, Connecticut 06520
United States
Not yet recruiting Site 0059

Local Institution
Newark, Delaware 19713
United States
Not yet recruiting Site 0027

Woodlands Medical Specialists, Pa
Pensacola, Florida 32503
United States
Recruiting Rami Owera, Site 0036

Local Institution
Tampa, Florida 33612
United States
Not yet recruiting Site 0004

Northside Hospital
Atlanta, Georgia 30342
United States
Recruiting Louis Garrot, Site 0144
770-496-9457
The University Of Chicago
Chicago, Illinois 60637
United States
Recruiting Randy Sweis, Site 0005

Illinois Cancer Care
Peoria, Illinois 61615
United States
Recruiting Madhuri Bajaj, Site 0006
309-243-3621
Local Institution
Baltimore, Maryland 21201
United States
Not yet recruiting Site 0150

Local Institution
Columbia, Maryland 21044
United States
Not yet recruiting Site 0181

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Recruiting Guru Sonpavde, Site 0166

Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting Guru Sonpavde, Site 0009
617-582-7334
Minnesota Oncology Hematology
Minneapolis, Minnesota 55404
United States
Recruiting Samith Kochuparambil, Site 0025

University of Minnesota
Minneapolis, Minnesota 55455
United States
Recruiting Arpit Rao, Site 0129
612-626-6541
The Nebraska Medical Center
Omaha, Nebraska 68118
United States
Recruiting Benjamin Teply, Site 0001
402-559-5255
Local Institution
Omaha, Nebraska 68310
United States
Not yet recruiting Site 0183

Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada 89169
United States
Recruiting Oscar Goodman, Site 0024

Local Institution
Camden, New Jersey 08103
United States
Not yet recruiting Site 0187

New York Oncology Hematology, Pc
Albany, New York 12208
United States
Recruiting David Shaffer, Site 0029

Local Institution
Lake Success, New York 11042
United States
Not yet recruiting Site 0069

Columbia University Medical Center (Cumc)
New York, New York 10032
United States
Recruiting Emerson Lim, Site 0047
212-342-0248
Local Institution
Cleveland, Ohio 44195
United States
Not yet recruiting Site 0191

Northwest Cancer Specialists, Pc
Tualatin, Oregon 97062
United States
Recruiting Ian Schnadig, Site 0028

Local Institution
Charleston, South Carolina 29425
United States
Not yet recruiting Site 0189

Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Recruiting Nancy Davis, Site 0007
414-805-4603
Texas Oncology, PA - Central Austin Cancer Center
Austin, Texas 78731
United States
Recruiting Jeffrey Yorio, Site 0030

Local Institution
Dallas, Texas 75390
United States
Not yet recruiting Site 0142

Local Institution
Fort Sam Houston, Texas 78234
United States
Not yet recruiting Site 0017

Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Recruiting Mark Fleming, Site 0023

Instituto Medico Especializado Alexander Fleming
Capital Federal, Buenos Aires 1426
Argentina
Recruiting Juan Sade, Site 0051

Local Institution
Ciudad Autonoma Buenos Aires, Buenos Aires 1118
Argentina
Not yet recruiting Site 0151

Local Institution
Ciudad Autonoma de Buenos Aires, Buenos Aires 1280
Argentina
Not yet recruiting Site 0049

Local Institution
Garran, Australian Capital Territory 2605
Australia
Not yet recruiting Site 0131

Local Institution
Kingswood, New South Wales 2747
Australia
Recruiting Site 0130

Local Institution
Macquarie Park, New South Wales 2109
Australia
Recruiting Site 0157

Local Institution
St Leonards, New South Wales 2065
Australia
Not yet recruiting Site 0043

Calvary Hospital
North Adelaide, South Australia 5006
Australia
Recruiting Rohit Joshi, Site 0143
+61882399536
Local Institution
Heidelberg, Victoria 3084
Australia
Not yet recruiting Site 0037

Local Institution
Murdoch, 6150
Australia
Recruiting Site 0038

Local Institution
Klagenfurt Am Woerthersee, 9020
Austria
Not yet recruiting Site 0090

Local Institution
Krems, 3500
Austria
Not yet recruiting Site 0091

Krankenhaus der Elisabethinen Linz GmbH
Linz, 4010
Austria
Recruiting Wolfgang Loidl, Site 0011
+43732076774445
AKH Allgemeines Krankenhaus Wien
Wien, 1090
Austria
Recruiting Shahrokh Shariat, Site 0012
+4314040054780
Local Institution
Bruxelles, 1200
Belgium
Recruiting Site 0060

Local Institution
Gent, 9000
Belgium
Recruiting Site 0063

Local Institution
Leuven, B-300
Belgium
Not yet recruiting Site 0061

Local Institution
Wilrijk, 2610
Belgium
Recruiting Site 0062

Local Institution
Fortaleza, Ceara 60130-241
Brazil
Not yet recruiting Site 0094

Local Institution
Ipatinga, Minas Gerais 35160-158
Brazil
Not yet recruiting Site 0099

Local Institution
Ijui, RIO Grande DO SUL 98700-000
Brazil
Not yet recruiting Site 0092

Local Institution
Porto Alegre, RIO Grande DO SUL 90610-000
Brazil
Not yet recruiting Site 0097

Local Institution
Barretos, SAO Paulo 14780-070
Brazil
Recruiting Site 0098

Local Institution
Jau, SAO Paulo 17210-080
Brazil
Not yet recruiting Site 0095

Local Institution
Sao Jose Do Rio Preto, SAO Paulo 15090-000
Brazil
Recruiting Site 0093

Local Institution
Rio De Janeiro, 20231-050
Brazil
Not yet recruiting Site 0164

Local Institution
Sao Paulo, 01246-000
Brazil
Not yet recruiting Site 0096

Local Institution
Abbotsford, British Columbia V2S 0C2
Canada
Not yet recruiting Site 0147

Local Institution
Kelowna, British Columbia V1Y 5L3
Canada
Not yet recruiting Site 0159

Local Institution
North York, Ontario M2K 1E1
Canada
Not yet recruiting Site 0182

Local Institution
Chicoutimi, Quebec G7H 5H6
Canada
Not yet recruiting Site 0192

Local Institution
Montreal, Quebec H3T 1M5
Canada
Not yet recruiting Site 0190

Pontificia Universidad Catolica de Chile
Santiago, Metropolitana 8330024
Chile
Recruiting Carolina Ibanez, Site 0053
+56942477513
Hospital Clinico de la Universidad De Chile
Santiago, Metropolitana 8380456
Chile
Recruiting Olga Barajas, Site 0052

Local Institution
Santiago, Metropolitana
Chile
Not yet recruiting Site 0054

Local Institution
Bucaramanga, 681004
Colombia
Not yet recruiting Site 0104

Oncomedica S.A.
Monteria, 230003
Colombia
Recruiting Fernando Luis Oviedo Martinez, Site 0103

Local Institution
?lborg, 9000
Denmark
Not yet recruiting Site 0106

Local Institution
Arhus, 8000
Denmark
Not yet recruiting Site 0107

Local Institution
Herlev, 2730
Denmark
Not yet recruiting Site 0108

Local Institution
Helsinki, 00290
Finland
Not yet recruiting Site 0148

Local Institution
Tampere, 33521
Finland
Recruiting Site 0145

Local Institution
Turku, 20521
Finland
Recruiting Site 0146

Local Institution
Besancon, 25030
France
Not yet recruiting Site 0101

Local Institution
Bordeaux, 33075
France
Not yet recruiting Site 0008

Local Institution
Marseille, 13273
France
Not yet recruiting Site 0075

Local Institution
Nice, 06189
France
Not yet recruiting Site 0074

Local Institution
Paris, 75014
France
Not yet recruiting Site 0163

Local Institution
Pierre Benite, 69310
France
Not yet recruiting Site 0020

Local Institution
Rennes Cedex, 35042
France
Not yet recruiting Site 0019

Local Institution
Saint Herblain Cedex, 44805
France
Not yet recruiting Site 0188

Local Institution
Strasbourg Cedex, 67091
France
Not yet recruiting Site 0002

Local Institution
TOULOUSE Cedex 9, 31059
France
Not yet recruiting Site 0003

Universitaetsklinikum Aachen
Aachen, 52074
Germany
Recruiting Julius van Essen, Site 0078
+492418088017
Local Institution
Erfurt, 99028
Germany
Not yet recruiting Site 0015

Klinik Essen-Mitte
Essen, 45136
Germany
Recruiting Susanne Krege, Site 0081

Johann Wolfgang Goethe Universitaet
Frankfurt Main, 60590
Germany
Recruiting Severine Banek, Site 0086
+4969630184778
Universitaetsmedizin Goettingen
Goettingen, 37075
Germany
Recruiting Arne Strauss, Site 0080
+49551398656
Local Institution
Heidelberg, 69120
Germany
Not yet recruiting Site 0014

Marien Hospital Herne
Herne, 44625
Germany
Recruiting Florian Roghmann, Site 0013
+4923234995252
Universitaetsklinikum Jena
Jena, 07747
Germany
Recruiting Marc-Oliver Grimm, Site 0010

Local Institution
Luebeck, 23538
Germany
Not yet recruiting Site 0084

Local Institution
Magdeburg, 39120
Germany
Not yet recruiting Site 0079

Local Institution
Mainz, 55101
Germany
Not yet recruiting Site 0100

Klinikum rechts der Isar der TU
Muenchen, 81675
Germany
Recruiting Margitta Retz, Site 0082

Local Institution
Nuernberg, 90419
Germany
Not yet recruiting Site 0016

Local Institution
Trier, 54292
Germany
Not yet recruiting Site 0085

Local Institution
Athens, 11528
Greece
Not yet recruiting Site 0018

Local Institution
Larissa, 41110
Greece
Recruiting Site 0031

Local Institution
Beer Sheva, 84101
Israel
Recruiting Site 0068

Local Institution
Haifa, 3109601
Israel
Recruiting Site 0066

Local Institution
Ramat Gan, 52621
Israel
Not yet recruiting Site 0067

Local Institution
Bari, 70124
Italy
Not yet recruiting Site 0064

IRCCS Istituto Nazionale Tumori Milano
Milano, 20133
Italy
Recruiting Andrea Necchi, Site 0032

Ospedale Di Carpi
Modena, 41012
Italy
Recruiting Claudia Mucciarini, Site 0065

Istituto Oncologico Veneto IOV
Padova, 35128
Italy
Recruiting Umberto Basso, Site 0033

Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Italy
Recruiting Luca Galli, Site 0034

Fondazione Policlinico Universitario A. Gemelli
Roma, 00168
Italy
Recruiting Giovanni Schinzari, Site 0035

Local Institution
Komaki-shi, Aichi 485-8520
Japan
Recruiting Site 0186

Local Institution
Fukuoka-shi, Fukuoka 8128582
Japan
Recruiting Site 0174

Local Institution
Sapporo-shi, Hokkaido 0030804
Japan
Recruiting Site 0184

Local Institution
Sapporo, Hokkaido 060-8543
Japan
Recruiting Site 0177

Local Institution
Sapporo, Hokkaido 0608604
Japan
Recruiting Site 0185

Local Institution
Tsukuba-shi, Ibaraki 3058576
Japan
Recruiting Site 0179

Local Institution
Yokohama-shi, Kanagawa 2220036
Japan
Recruiting Site 0169

Local Institution
Niigata-shi, Niigata 9518520
Japan
Recruiting Site 0168

Local Institution
Osaka-sayama-shi, Osaka 5898511
Japan
Recruiting Site 0173

Local Institution
Takatsuki-shi, Osaka 5698686
Japan
Recruiting Site 0175

Local Institution
Hidaka-shi, Saitama 3501298
Japan
Recruiting Site 0176

Local Institution
Hamamatsu-shi, Shizuoka 4313192
Japan
Recruiting Site 0170

Local Institution
Minato-ku, Tokyo 1058470
Japan
Not yet recruiting Site 0178

Local Institution
Shinjuku-Ku, Tokyo 1608582
Japan
Recruiting Site 0172

Local Institution
Kita-gun, 7610793
Japan
Recruiting Site 0171

Local Institution
Kyoto, 6068507
Japan
Recruiting Site 0180

Local Institution
Goyang-si, Gyeonggi-do 10408
Korea, Republic of
Recruiting Site 0137

Local Institution
Seoul, 02841
Korea, Republic of
Recruiting Site 0140

Local Institution
Seoul, 03080
Korea, Republic of
Recruiting Site 0136

Local Institution
Seoul, 06351
Korea, Republic of
Recruiting Site 0138

Local Institution
La Paz, BAJA Californa SUR 23040
Mexico
Not yet recruiting Site 0160

Local Institution
Df, Distrito Federal 06720
Mexico
Not yet recruiting Site 0161

Local Institution
Zapopan, Jalisco 45050
Mexico
Not yet recruiting Site 0102

Local Institution
Monterrey, Nuevo LEON 64460
Mexico
Not yet recruiting Site 0056

Local Institution
Colima, 28017
Mexico
Not yet recruiting Site 0105

Local Institution
Amsterdam, 1066 CX
Netherlands
Not yet recruiting Site 0070

Local Institution
Groningen, 9713 GZ
Netherlands
Not yet recruiting Site 0072

Local Institution
Sittard-Geleen, 6162 BG
Netherlands
Not yet recruiting Site 0073

Local Institution
Auckland, 1023
New Zealand
Recruiting Site 0087

Local Institution
Christchurch, 8011
New Zealand
Not yet recruiting Site 0089

Local Institution
Gralum, 1714
Norway
Recruiting Site 0158

Local Institution
Lorenskog, 1478
Norway
Not yet recruiting Site 0132

Local Institution
Oslo, 0379
Norway
Recruiting Site 0133

Local Institution
Lisboa, 1649-035
Portugal
Not yet recruiting Site 0153

Local Institution
Porto, 4200-072
Portugal
Not yet recruiting Site 0152

Local Institution
Bucharest, 020122
Romania
Not yet recruiting Site 0058

Local Institution
Craiova, 200347
Romania
Not yet recruiting Site 0076

Local Institution
Saint-Petersburg, 194044
Russian Federation
Recruiting Site 0044

Local Institution
St Petersburg, 197758
Russian Federation
Recruiting Site 0057

Local Institution
Singapore, 169610
Singapore
Recruiting Site 0154

Local Institution
Lugo, 27003
Spain
Not yet recruiting Site 0113

Local Institution
Madrid, 28007
Spain
Not yet recruiting Site 0111

Local Institution
Madrid, 28033
Spain
Not yet recruiting Site 0112

Local Institution
Madrid, 28041
Spain
Not yet recruiting Site 0114

Local Institution
Malaga, 29010
Spain
Not yet recruiting Site 0156

Local Institution
Sevilla, 41013
Spain
Not yet recruiting Site 0109

Local Institution
Kaohsiung, 883
Taiwan
Recruiting Site 0135

Local Institution
Taichung, 40705
Taiwan
Recruiting Site 0165

Local Institution
Taipei, 10048
Taiwan
Not yet recruiting Site 0141

Local Institution
Taipei, 11217
Taiwan
Recruiting Site 0139

Local Institution
Chelmsford, Essex CM1 7ET
United Kingdom
Not yet recruiting Site 0128

Local Institution
York, Yorkshire YO31 8HE
United Kingdom
Not yet recruiting Site 0127

Local Institution
Glasgow, G12 0YN
United Kingdom
Not yet recruiting Site 0122

Local Institution
Lancaster, LA1 4RP
United Kingdom
Not yet recruiting Site 0117

Local Institution
London, SE1 9RT
United Kingdom
Not yet recruiting Site 0121

Local Institution
Oxford, OX3 7LE
United Kingdom
Not yet recruiting Site 0124