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BRIEF TITLE: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)

A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)


  • Org Study ID: CA209-274
  • Secondary ID: 2014-003626-40
  • NCT ID: NCT02632409
  • NCT Alias:
  • Sponsor: Bristol-Myers Squibb - Industry
  • Source: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

Overal Status Start Date Phase Study Type
Recruiting February 11, 2016 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Disease free survival (DFS)

Primary Outcome 1 - Time Frame: Approximately 5 years after the first subject is randomized

Condition:

  • Various Advanced Cancer

Eligibility

Criteria:
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Must have had invasive urothelial cancer at high risk of recurrence originating in the
bladder, ureter, or renal pelvis

- Must have had radical surgical resection (e.g. radical cystectomy), performed within
the last 90 days

- Must have disease free status as determined by imaging within 4 weeks of dosing

- Tumor tissue must be provided for biomarker analysis

- Patients who have not received prior neoadjuvant cisplatin chemotherapy must be
ineligible for or refuse cisplatin-based adjuvant chemotherapy

Exclusion Criteria:

- Partial bladder or kidney removal (eg, partial cystectomy)

- Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following
surgical removal of bladder cancer

- Subjects with active, known or suspected autoimmune disease

- Prior malignancy active within the previous 3 years except for locally curable cancers
that have been apparently cured

- Condition requiring systemic treatment with either corticosteroids or other
immunosuppressive medications within 14 day of study drug administration

- Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus
ribonucleic acid (HCV antibody) indicating acute or chronic infection
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, please email:

Phone:

Email: Clinical.Trials@bms.com

Link: BMS Clinical Trial Information

Locations

Facility Status Contact
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska 99503
United States
Recruiting William Clark, Site 0015
907-276-1455
Arizona Oncology Associates
Tucson, Arizona 85711
United States
Recruiting Christopher Di Simone, Site 0179

University Of California San Francisco-Fresno
Fresno, California 93701
United States
Recruiting Uzair Chaudhary, Site 0061
559-499-6636
University Of California - Davis
Sacramento, California 95817
United States
Recruiting Chong-Xian Pan, Site 0172

California Pacific Medical Center
San Francisco, California 94115
United States
Recruiting Ari Baron, Site 0005
415-600-3613
Rocky Mountain Cancer Centers
Lakewood, Colorado 80228
United States
Recruiting Nauman Moazzam, Site 0178
303-285-5081
University Of Florida
Gainesville, Florida 32610
United States
Recruiting Long Dang, Site 0167
352-273-7832
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United States
Recruiting Joseph Pizzolato, Site 0030
305-674-2625
H. Lee Moffitt Cancer Center
Tampa, Florida 33612
United States
Recruiting Jingsong Zhang, Site 0008
813-745-1172
Loyola University Medical Center
Maywood, Illinois 60153
United States
Recruiting Elizabeth Henry, Site 0168

Ft. Wayne Med Onco-Hema Inc
Fort Wayne, Indiana 46804
United States
Recruiting Sunil Babu, Site 0094
260-969-7864
Tulane University
New Orleans, Louisiana 70112
United States
Recruiting A. Oliver Sartor, Site 0171

Cancer & Hematology Centers Of Western Michigan
Grand Rapids, Michigan 49503
United States
Recruiting Jared Knol, Site 0173
616-954-9800
Fairview Health Services
Burnsville, Minnesota 55337
United States
Recruiting Gautam Jha, Site 0051
952-836-3608
Mayo Clinic
Rochester, Minnesota 55905
United States
Recruiting Roxana Dronca, Site 0004
507-284-6420
GU Research Network, LLC
Omaha, Nebraska 68130
United States
Recruiting Luke Nordquist, Site 0003
402-991-8468
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
United States
Recruiting Nicholas Vogelzang, Site 0177

New York Oncology Hematology, P.C.
Albany, New York 12208
United States
Recruiting David Shaffer, Site 0176

Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting Gurkamal Chatta, Site 0157

Winthrop University Hospital
Mineola, New York 11501
United States
Recruiting Mary O'Keeffe, Site 0007
517-663-4895
Mount Sinai Medical Center
New York, New York 10029
United States
Recruiting Matthew Galsky, Site 0006
212-824-7372
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting Dean Bajorin, Site 0001
646-422-4333
University Of North Carolina
Chapel Hill, North Carolina 27599-7305
United States
Recruiting Matthew Milowsky, Site 0166

Providence Portland Medical Center
Portland, Oregon 97213
United States
Recruiting Brendan Curti, Site 0044
503-215-2604
Oregon Health & Science University
Portland, Oregon 97239
United States
Recruiting Jeremy Cetnar, Site 0010
503-494-3618
Northwest Cancer Specialists, Pc
Tualatin, Oregon 97062
United States
Recruiting Ian Schnadig, Site 0180

Lehigh Valley Health Network
Allentown, Pennsylvania 18103
United States
Recruiting Suresh Nair, Site 0074
610-402-1642
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
Recruiting Shifeng Mao, Site 0011
412-359-8379
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania 15232
United States
Recruiting Leonard Appleman, Site 0040
412-623-8962
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Recruiting Neal Shore, Site 0169

Erlanger Oncology & Hematology - Univ. of TN
Chattanooga, Tennessee 37403
United States
Recruiting Robert Graham, Site 0009
423-778-2982
COIBA
Berazategui, Buenos Aires 1880
Argentina
Recruiting Mirta Susana Varela, Site 0021
+541143509606
Instituto Medico Especializado Alexander Fleming
Capital Federal, Buenos Aires 1426
Argentina
Recruiting Juan Sade, Site 0090
+541132218900
Hospital Italiano De Buenos Aires
Ciudad Autonoma De Buenos Aire, Buenos Aires 1181
Argentina
Recruiting Lorena Lupinacci, Site 0089
+541149590200
Fundacion Investigar
Ciudad de Buenos Aires, Buenos Aires 1025
Argentina
Recruiting Ernesto Korbenfeld, Site 0022
541163819972
Clinica Viedma S.A.
Viedma, Rio Negro 8500
Argentina
Recruiting Ruben Kowalyszyn, Site 0102
+542920424417
Centro Para La Atencion Integral Del Paciente Oncologico
San Miguel De Tucuman, Tucuman 4000
Argentina
Recruiting Felipe Palazzo, Site 0020
+543814215825
Liverpool Hospital
Liverpool, New South Wales 2170
Australia
Recruiting Bavanthi Balakrishnar, Site 0048
+61287385234
Royal North Shore Hospital
St. Leonards, New South Wales 2065
Australia
Recruiting Alexander Guminski, Site 0047
+61294631362
Calvary Mater Newcastle
Waratah, New South Wales 2298
Australia
Recruiting Craig Gedye, Site 0046
+61240143282
Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112
Australia
Recruiting Christopher Hocking, Site 0050
+61882820833
Local Institution
Frankston, Victoria 3199
Australia
Not yet recruiting Site 0184

St John of God Murdoch Hospital
Perth, Western Australia 6150
Australia
Recruiting Kynan Feeney, Site 0175
+61894288556
Krankenhaus Der Barmherzigen Schwestern
Linz, 4010
Austria
Recruiting Wolfgang Loidl, Site 0133

Local Institution
Salzburg, 5020
Austria
Not yet recruiting Site 0136

Akh Wien
Vienna, 1090
Austria
Recruiting Gottfried Locker, Site 0132

AKH Allgemeines Krankenhaus Wien
Wien, 1090
Austria
Recruiting Shahrokh Shariat, Site 0183

Local Institution
Hasselt, 3500
Belgium
Recruiting Site 0029

Chu De Liege
Liege, 4000
Belgium
Recruiting Christine Gennigens, Site 0027
+3242844454
Local Institution
Ijui, Rio Grande Do Sul 98700-000
Brazil
Recruiting Site 0071

Local Institution
Porto Alegre, Rio Grande Do Sul 90610-000
Brazil
Recruiting Site 0072

Local Institution
Barretos, Sao Paulo 14780-070
Brazil
Recruiting Site 0070

Local Institution
S?o Paulo, Sao Paulo 03102-006
Brazil
Recruiting Site 0100

Local Institution
Sao Paulo, 05403-010
Brazil
Recruiting Site 0073

Local Institution
Edmonton, Alberta T6G 1Z2
Canada
Recruiting Site 0139

Mcgill University Health Center - Royal Victoria Hospital
Montreal, Quebec H4A 3J1
Canada
Recruiting Wassim Kassouf, Site 0109

Local Institution
Sherbrooke, Quebec J1H 5N4
Canada
Recruiting Site 0112

Centre Hospitalier De L'Universite De Montreal
Montreal, H2X 0A9
Canada
Recruiting Fred Saad, Site 0101
514890800026161
Fundacion Arturo Lopez Perez
Santiago, Metropolitana
Chile
Recruiting Pamela Salman, Site 0099
+5624457254
Instituto Oncologico Clinica Renaca
Vina Del Mar, Valparaiso 2540364
Chile
Recruiting Pablo Gonzalez Mella, Site 0038
+56322891219
Clinica Alemana de Temuco S.A.
Temuco, 4810297
Chile
Recruiting Felipe Rey, Site 0137
56452201611
Local Institution
Beijing, Beijing 100001
China
Not yet recruiting Site 0191

Local Institution
Fuzhou, Fujian 350001
China
Not yet recruiting Site 0198

Local Institution
Wuhan, Hubei 430030
China
Not yet recruiting Site 0196

Local Institution
Shanghai, Shanghai 200032
China
Not yet recruiting Site 0193

Local Institution
Hangzhou, Zhejiang 310014
China
Not yet recruiting Site 0195

Administradora Del Country S.A. - Clinica Del Country
Bogota,
Colombia
Recruiting Andres Cardona, Site 0092
57153004702907
Fundacion Oftalmologica De Santander - Foscal
Floridablanca,
Colombia
Recruiting Milton Salazar, Site 0093
57767979796161
Hospital Pablo Tobon Uribe
Medellin, MEDELLIN
Colombia
Recruiting Jose Correa, Site 0091
5744459753
Local Institution
Aalborg, 9100
Denmark
Recruiting Site 0108

Local Institution
Aarhus C, 8000
Denmark
Recruiting Site 0106

Local Institution
Copenhagen, 2100
Denmark
Recruiting Site 0107

Local Institution
La Roche sur Yon, 85320
France
Recruiting Site 0115

Local Institution
Marseille Cedex 9, 13273
France
Recruiting Site 0080

Local Institution
Paris, 75475
France
Recruiting Site 0081

Local Institution
Strasbourg, 67091
France
Recruiting Site 0113

Local Institution
Suresnes, 92151
France
Recruiting Site 0097

Local Institution
Villejuif, 94800
France
Recruiting Site 0098

Zeisigwaldkliniken Bethanien
Chemnitz, 09130
Germany
Recruiting Hanjo Belz, Site 0131

Klinik Essen-Mitte
Essen, 45136
Germany
Recruiting Susanne Krege, Site 0125

Univ Klinikum Der Ernst-Moritz-Arndt-Univ Greifswald
Greifswald, 17475
Germany
Recruiting Uwe Zimmermann, Site 0127

Uni Hamburg-Eppendorf
Hamburg, 20246
Germany
Recruiting Gunhild von Amsberg, Site 0126

Local Institution
Heidelberg, 69120
Germany
Recruiting Site 0124

Universitaetsklinikum Jena
Jena, 07743
Germany
Recruiting Marc-Oliver Grimm, Site 0123

Local Institution
Marburg, 35043
Germany
Not yet recruiting Site 0188

Universitaetsklinikum Muenster
Muenster, 48149
Germany
Recruiting Martin Boegemann, Site 0128

Klinikum rechts der Isar der Technischen Universitat Munchen
Munich, 81675
Germany
Recruiting Juergen Gschwend, Site 0122

Klinikum Der Universitaet Regensburg
Regensburg, 93053
Germany
Recruiting Albrecht Reichle, Site 0130

Klinikum Stuttgart
Stuttgart, 70174
Germany
Recruiting Jan Schleicher, Site 0129

Local Institution
Athens, 11528
Greece
Recruiting Site 0110

Local Institution
Thessaloniki, 54007
Greece
Recruiting Site 0111

Local Institution
Wilton, Cork
Ireland
Recruiting Site 0054

Adelaide And Meath Hospital
Dublin,
Ireland
Recruiting Ray Mcdermott, Site 0052

Local Institution
Haifa, 3109601
Israel
Recruiting Site 0118

Local Institution
Jerusalem, 91120
Israel
Recruiting Site 0121

Local Institution
Ramat Gan, 5262100
Israel
Recruiting Site 0120

Local Institution
Zerifin, 70300
Israel
Recruiting Site 0119

Ospedale S. Donato - Usl 8
Arezzo, 52100
Italy
Recruiting Sergio Bracarda, Site 0088

IRCCS Istituto Nazionale Tumori
Milano, 20133
Italy
Recruiting Andrea Necchi, Site 0082

Local Institution
Pavia, 27100
Italy
Not yet recruiting Site 0087

Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Italy
Recruiting Alfredo Falcone, Site 0084

Istituto Regina Elena
Roma, 00144
Italy
Recruiting Francesco Cognetti, Site 0085

Azienda Ospedaliera S. Camillo Forlanini
Roma, 00152
Italy
Recruiting Cora Sternberg, Site 0086

AOUS - Policlinico S.Maria Alle Scotte
Siena, 53100
Italy
Recruiting Michele Maio, Site 0083

Local Institution
Akita-shi, Akita 0108543
Japan
Recruiting Site 0142

Local Institution
Hirosaki-shi, Aomori 036-8563
Japan
Recruiting Site 0144

Local Institution
Chiba-shi, Chiba 260-8717
Japan
Recruiting Site 0143

Local Institution
Fukuoka-shi, Fukuoka 8128582
Japan
Recruiting Site 0162

Local Institution
Sapporo-shi, Hokai-do 060-8543
Japan
Recruiting Site 0160

Local Institution
Sapporo-shi, Hokkaido 0608648
Japan
Recruiting Site 0161

Local Institution
Tsukuba-shi, Ibaraki 3058576
Japan
Recruiting Site 0148

Local Institution
Nagasaki-shi, Nagasaki 8528501
Japan
Recruiting Site 0163

Local Institution
Niigata-shi, Niigata 9518520
Japan
Recruiting Site 0150

Local Institution
Okayama-shi, Okayama 7000914
Japan
Recruiting Site 0141

Local Institution
Higashinari-ku, Osaka 5378511
Japan
Recruiting Site 0164

Local Institution
Osaka-Sayama-Shi, Osaka 5898511
Japan
Recruiting Site 0149

Local Institution
Hamamatsu-shi, Shizuoka 4313192
Japan
Recruiting Site 0151

Local Institution
Bunkyo-ku, Tokyo 113-8603
Japan
Recruiting Site 0146

Local Institution
Shinjuku-Ku, Tokyo 1608582
Japan
Recruiting Site 0145

Local Institution
Shinjuku-ku, Tokyo 1628666
Japan
Recruiting Site 0147

Local Institution
Seongnam-si, Gyeonggi-do 13620
Korea, Republic of
Recruiting Site 0155

Local Institution
Seoul, 03722
Korea, Republic of
Recruiting Site 0154

Local Institution
Seoul, 05505
Korea, Republic of
Recruiting Site 0152

Local Institution
Seoul, 06351
Korea, Republic of
Recruiting Site 0156

Local Institution
Df, Distrito Federal 06720
Mexico
Recruiting Site 0138

Local Institution
Mexico City, Distrito Federal 14080
Mexico
Recruiting Site 0034

Local Institution
Mexico, Distrito Federal 06700
Mexico
Recruiting Site 0116

Local Institution
Mexico, Distrito Federal 14080
Mexico
Recruiting Site 0039

Local Institution
Guadalajara, Jalisco 44270
Mexico
Recruiting Site 0035

Local Institution
Monterrey, Nuevo Leon 64460
Mexico
Recruiting Site 0032

Local Institution
Amsterdam, 1105 AZ
Netherlands
Recruiting Site 0069

Local Institution
Maastrict, 6229 HX
Netherlands
Recruiting Site 0068

Local Institution
Nijmegen, 6525 GA
Netherlands
Recruiting Site 0041

Local Institution
Arequipa,
Peru
Not yet recruiting Site 0165

Clinica Internacional sede San Borja
Lima, Lima 41
Peru
Recruiting Renzo Salas, Site 0043

Klinika Onkologii i Radioterapii
Gdansk, 80-952
Poland
Recruiting Elzbieta Senkus-Konefka, Site 0055
+48583492916
Regionalny Osrodek Onkologiczny
Lodz, 93-513
Poland
Recruiting Ewa Kalinka-Warzocha, Site 0057
+48426895600
Local Institution
Warsaw, 02-797
Poland
Not yet recruiting Site 0187

Klinika Urologii i Onkologii Urologicznej
Wroclaw, 50-556
Poland
Recruiting Romuald Zdrojowy, Site 0058
+48717331030
Local Institution
Bucuresti, 021389
Romania
Recruiting Site 0182

Local Institution
Craiova, 200347
Romania
Recruiting Site 0096

Local Institution
Floresti, 407280
Romania
Recruiting Site 0078

Local Institution
Timisoara, Timis, 300239
Romania
Recruiting Site 0181

Local Institution
Moscow, 115478
Russian Federation
Not yet recruiting Site 0018

Local Institution
Moscow, 125284
Russian Federation
Recruiting Site 0140

Local Institution
Saint-Petersburg, 197758
Russian Federation
Recruiting Site 0031

Local Institution
Badalona-barcelona, 08916
Spain
Recruiting Site 0067

Local Institution
Barcelona, 08035
Spain
Recruiting Site 0066

Local Institution
Madrid, 28007
Spain
Recruiting Site 0064

Local Institution
Madrid, 28034
Spain
Recruiting Site 0062

Local Institution
Madrid, 28041
Spain
Recruiting Site 0063

Local Institution
Sevilla, 41013
Spain
Recruiting Site 0065

Local Institution
Lund, 221 85
Sweden
Recruiting Site 0105

Kantonsspital Basel
Basel, 4031
Switzerland
Recruiting Frank Stenner, Site 0134

OnkoZentrum Zurich
Zuerich, 8038
Switzerland
Recruiting Ulf Petrausch, Site 0135

Local Institution
Kaohsiung, 80765
Taiwan
Recruiting Site 0158

Local Institution
Taichung, 404
Taiwan
Recruiting Site 0159

Local Institution
Taipei, 100
Taiwan
Recruiting Site 0153

Local Institution
London, Greater London NW3 2QG
United Kingdom
Not yet recruiting Site 0017

Local Institution
London, Greater London SE1 9RT
United Kingdom
Recruiting Site 0036

Local Institution
Manchester, Greater Manchester M20 4BX
United Kingdom
Recruiting Site 0025

Local Institution
Edinburgh, Midlothian EH4 2XU
United Kingdom
Recruiting Site 0076

Local Institution
Sutton, Surrey SM2 5PT
United Kingdom
Recruiting Site 0024

Cancer Research Centre
Sheffield, Yorkshire S10 2SJ
United Kingdom
Recruiting Linda Evans, Site 0059

Local Institution
London, SW3 6JJ
United Kingdom
Recruiting Site 0114