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An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer (CheckMate 274)

This study is currently recruiting participants.
Verified November 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02632409
First Posted: December 16, 2015
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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.

Condition Intervention Phase
Various Advanced Cancer Biological: Nivolumab Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Disease free survival (DFS) [ Time Frame: Approximately 5 years after the first subject is randomized ]
    DFS defined as the time between the date of randomization and the date of first recurrence or death (of any cause) whichever occurs first.


Secondary Outcome Measures:
  • Non-Urothelial track recurrence free survival (NUTRFS) [ Time Frame: Approximately 5 years after the first subject is randomized ]
    NUTRFS is defined as the time between the date of randomization and the date of first local non urothelial tract or distant recurrence or death (of any cause), whichever occurs first.

  • Disease specific survival (DSS) [ Time Frame: Approximately 5 years after the first subject is randomized ]
    DSS is defined the time between the date of randomization and the date of death due to disease (urothelial cancer).

  • Overall survival (OS) [ Time Frame: Approximately 5 years after the first subject is randomized ]
    OS is defined as the time between the date of randomization and the date of death (of any cause).


Estimated Enrollment: 640
Actual Study Start Date: February 11, 2016
Estimated Study Completion Date: May 1, 2020
Estimated Primary Completion Date: April 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab
Nivolumab dose as specified
Biological: Nivolumab
Placebo Comparator: Placebo
Placebo dose as specified
Other: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632409


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, Alaska
Alaska Urological Institute dba Alaska Clinical Research Center Recruiting
Anchorage, Alaska, United States, 99503
Contact: William Clark, Site 0015    907-276-1455      
United States, Arizona
Arizona Oncology Associates Recruiting
Tucson, Arizona, United States, 85711
Contact: Christopher Di Simone, Site 0179         
United States, California
University Of California San Francisco-Fresno Recruiting
Fresno, California, United States, 93701
Contact: Uzair Chaudhary, Site 0061    559-499-6636      
University Of California - Davis Recruiting
Sacramento, California, United States, 95817
Contact: Chong-Xian Pan, Site 0172         
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Ari Baron, Site 0005    415-600-3613      
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Lakewood, Colorado, United States, 80228
Contact: Nauman Moazzam, Site 0178    303-285-5081      
United States, Florida
University Of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Long Dang, Site 0167    352-273-7832      
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Joseph Pizzolato, Site 0030    305-674-2625      
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Jingsong Zhang, Site 0008    813-745-1172      
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Elizabeth Henry, Site 0168    708-327-2237      
United States, Indiana
Ft. Wayne Med Onco-Hema Inc Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Sunil Babu, Site 0094    260-484-8830      
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: A. Oliver Sartor, Site 0171         
United States, Michigan
Cancer & Hematology Centers Of Western Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Jared Knol, Site 0173    616-954-9800      
United States, Minnesota
Fairview Health Services Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Gautam Jha, Site 0051    952-836-3608      
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Roxana Dronca, Site 0004    507-284-6420      
United States, Nebraska
GU Research Network, LLC Recruiting
Omaha, Nebraska, United States, 68130
Contact: Luke Nordquist, Site 0003    402-991-8468      
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Nicholas Vogelzang, Site 0177         
United States, New York
New York Oncology Hematology, P.C. Recruiting
Albany, New York, United States, 12208
Contact: David Shaffer, Site 0176         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Gurkamal Chatta, Site 0157         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mary O'Keeffe, Site 0007    517-663-4895      
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Matthew Galsky, Site 0006    212-824-7372      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Dean Bajorin, Site 0001    646-422-4333      
United States, North Carolina
University Of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599-7305
Contact: Matthew Milowsky, Site 0166         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Brendan Curti, Site 0044    503-215-2604      
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Jeremy Cetnar, Site 0010    503-494-3618      
Northwest Cancer Specialists, Pc Recruiting
Tualatin, Oregon, United States, 97062
Contact: Ian Schnadig, Site 0180         
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Suresh Nair, Site 0074    610-402-1642      
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Shifeng Mao, Site 0011    412-359-8379      
University of Pittsburgh Cancer Institute Cancer Services Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Leonard Appleman, Site 0040    412-623-8962      
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Neal Shore, Site 0169         
United States, Tennessee
Erlanger Oncology & Hematology - Univ. of TN Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Robert Graham, Site 0009    423-778-2982      
Argentina
COIBA Recruiting
Berazategui, Buenos Aires, Argentina, 1880
Contact: Mirta Susana Varela, Site 0021    +541143509606      
Instituto Medico Especializado Alexander Fleming Recruiting
Capital Federal, Buenos Aires, Argentina, 1426
Contact: Juan Sade, Site 0090    +541132218900      
Hospital Italiano De Buenos Aires Recruiting
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181
Contact: Federico Cayol, Site 0089    +541149590200      
Fundacion Investigar Recruiting
Ciudad de Buenos Aires, Buenos Aires, Argentina, 1025
Contact: Ernesto Korbenfeld, Site 0022    541163819972      
Clinica Viedma S.A. Recruiting
Viedma, RIO Negro, Argentina, 8500
Contact: Ruben Kowalyszyn, Site 0102    +542920424417      
Centro Para La Atencion Integral Del Paciente Oncologico Recruiting
San Miguel De Tucuman, Tucuman, Argentina, 4000
Contact: Felipe Palazzo, Site 0020    +543814215825      
Australia, New South Wales
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Bavanthi Balakrishnar, Site 0048    +61287385234      
Royal North Shore Hospital Recruiting
St. Leonards, New South Wales, Australia, 2065
Contact: Alexander Guminski, Site 0047    +61294631362      
Calvary Mater Newcastle Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Craig Gedye, Site 0046    +61240143282      
Australia, South Australia
Lyell McEwin Hospital Recruiting
Elizabeth Vale, South Australia, Australia, 5112
Contact: Christopher Hocking, Site 0050    +61882820833      
Australia, Victoria
Local Institution Recruiting
Frankston, Victoria, Australia, 3199
Contact: Site 0184         
Australia, Western Australia
St John of God Murdoch Hospital Recruiting
Perth, Western Australia, Australia, 6150
Contact: Kynan Feeney, Site 0175    +61894288556      
Austria
Krankenhaus Der Barmherzigen Schwestern Recruiting
Linz, Austria, 4010
Contact: Wolfgang Loidl, Site 0133         
Salzburger Landeskliniken Lkh Recruiting
Salzburg, Austria, 5020
Contact: Daniela Colleselli, Site 0136         
Akh Wien Recruiting
Vienna, Austria, 1090
Contact: Gottfried Locker, Site 0132         
AKH Allgemeines Krankenhaus Wien Recruiting
Wien, Austria, 1090
Contact: Shahrokh Shariat, Site 0183         
Belgium
Local Institution Recruiting
Hasselt, Belgium, 3500
Contact: Site 0029         
Chu De Liege Recruiting
Liege, Belgium, 4000
Contact: Christine Gennigens, Site 0027    +3243667664      
Local Institution Withdrawn
Roeselare, Belgium, 8800
Brazil
Local Institution Recruiting
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Contact: Site 0071         
Local Institution Recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
Contact: Site 0072         
Local Institution Recruiting
Barretos, SAO Paulo, Brazil, 14780-070
Contact: Site 0070         
Local Institution Recruiting
São Paulo, SAO Paulo, Brazil, 03102-006
Contact: Site 0100         
Local Institution Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Site 0073         
Canada, Alberta
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0139         
Canada, Quebec
Mcgill University Health Center - Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Wassim Kassouf, Site 0109         
Local Institution Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Site 0112         
Canada
Centre Hospitalier De L'Universite De Montreal Recruiting
Montreal, Canada, H2X 0A9
Contact: Fred Saad, Site 0101    514890800026161      
Chile
Fundacion Arturo Lopez Perez Recruiting
Santiago, Metropolitana, Chile
Contact: Pamela Salman, Site 0099    +5624457254      
Instituto Oncologico Clinica Renaca Recruiting
Vina Del Mar, Valparaiso, Chile, 2540364
Contact: Pablo Gonzalez Mella, Site 0038    +56322891219      
Clinica Alemana de Temuco S.A. Recruiting
Temuco, Chile, 4810297
Contact: Felipe Rey, Site 0137    56452201611      
China, Beijing
Local Institution Not yet recruiting
Beijing, Beijing, China, 100001
Contact: Site 0191         
Local Institution Not yet recruiting
Beijing, Beijing, China, 100034
Contact: Site 0206         
China, Chongqing
Local Institution Not yet recruiting
Chongqing, Chongqing, China, 400030
Contact: Site 0210         
China, Fujian
Local Institution Not yet recruiting
Fuzhou, Fujian, China, 350001
Contact: Site 0198         
China, Guangdong
Local Institution Not yet recruiting
Guangzhou, Guangdong, China, 510120
Contact: Site 0222         
Local Institution Not yet recruiting
Guangzhou, Guangdong, China, 510288
Contact: Site 0203         
China, Guangxi
Local Institution Not yet recruiting
Nanning, Guangxi, China, 530021
Contact: Site 0227         
China, Hubei
Local Institution Not yet recruiting
Wuhan, Hubei, China, 430030
Contact: Site 0196         
China, Jiangsu
Local Institution Not yet recruiting
Nanjing, Jiangsu, China, 210008
Contact: Site 0220         
Local Institution Not yet recruiting
Nanjing, Jiangsu, China, 210029
Contact: Site 0204         
China, Jiangxi
Local Institution Not yet recruiting
Nanchang, Jiangxi, China, 330006
Contact: Site 0223         
China, Shan3xi
Local Institution Not yet recruiting
Xi'an, Shan3xi, China, 710061
Contact: Site 0190         
China, Shandong
Local Institution Recruiting
Yantai, Shandong, China, 264000
Contact: Site 0212         
China, Shanghai
Local Institution Recruiting
Shanghai, Shanghai, China, 200032
Contact: Site 0193         
Local Institution Not yet recruiting
Shanghai, Shanghai, China, 200040
Contact: Site 0199         
Local Institution Recruiting
Shanghai, Shanghai, China, 200040
Contact: Site 0217         
China, Sichuan
Local Institution Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Site 0229         
Local Institution Not yet recruiting
Chengdu, Sichuan, China, 610072
Contact: Site 0219         
China, Zhejiang
Local Institution Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Site 0221         
Local Institution Not yet recruiting
Hangzhou, Zhejiang, China, 310014
Contact: Site 0195         
Local Institution Not yet recruiting
Wenzhou, Zhejiang, China, 3325000
Contact: Site 0230         
Colombia
Administradora Del Country S.A. - Clinica Del Country Recruiting
Bogota, Colombia
Contact: Andres Cardona, Site 0092    57153004702907      
Fundacion Oftalmologica De Santander - Foscal Recruiting
Floridablanca, Colombia
Contact: Milton Salazar, Site 0093    57767979796161      
Hospital Pablo Tobon Uribe Recruiting
Medellin, Colombia, MEDELLIN
Contact: Jose Correa, Site 0091    5744459753      
Denmark
Local Institution Recruiting
Aalborg, Denmark, 9100
Contact: Site 0108         
Local Institution Recruiting
Aarhus C, Denmark, 8000
Contact: Site 0106         
Local Institution Recruiting
Copenhagen, Denmark, 2100
Contact: Site 0107         
France
Local Institution Recruiting
La Roche sur Yon, France, 85320
Contact: Site 0115         
Local Institution Recruiting
Marseille Cedex 9, France, 13273
Contact: Site 0080         
Local Institution Recruiting
Paris, France, 75475
Contact: Site 0081         
Local Institution Recruiting
Strasbourg, France, 67091
Contact: Site 0113         
Local Institution Recruiting
Suresnes, France, 92151
Contact: Site 0097         
Local Institution Recruiting
Villejuif, France, 94800
Contact: Site 0098         
Germany
Zeisigwaldkliniken Bethanien Recruiting
Chemnitz, Germany, 09130
Contact: Hanjo Belz, Site 0131         
Klinik Essen-Mitte Recruiting
Essen, Germany, 45136
Contact: Susanne Krege, Site 0125         
Univ Klinikum Der Ernst-Moritz-Arndt-Univ Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Uwe Zimmermann, Site 0127         
Uni Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Gunhild von Amsberg, Site 0126         
Local Institution Recruiting
Heidelberg, Germany, 69120
Contact: Site 0124         
Universitaetsklinikum Jena Recruiting
Jena, Germany, 07747
Contact: Marc-Oliver Grimm, Site 0123         
Universitatsklinikum Giessen Und Marburg Recruiting
Marburg, Germany, 35043
Contact: Axel Hegele, Site 0188         
Universitaetsklinikum Muenster Recruiting
Muenster, Germany, 48149
Contact: Martin Boegemann, Site 0128         
Klinikum rechts der Isar der Technischen Universitat Munchen Recruiting
Munich, Germany, 81675
Contact: Juergen Gschwend, Site 0122         
Local Institution Recruiting
Nuernberg, Germany, 90419
Contact: Site 0185         
Klinikum Der Universitaet Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Albrecht Reichle, Site 0130         
Klinikum Stuttgart Recruiting
Stuttgart, Germany, 70174
Contact: Jan Schleicher, Site 0129         
Greece
Local Institution Recruiting
Athens, Greece, 11528
Contact: Site 0110         
Local Institution Recruiting
Thessaloniki, Greece, 54007
Contact: Site 0111         
Ireland
Local Institution Recruiting
Wilton, Cork, Ireland
Contact: Site 0054         
Adelaide And Meath Hospital Recruiting
Dublin, Ireland
Contact: Ray Mcdermott, Site 0052         
Israel
Local Institution Recruiting
Haifa, Israel, 3109601
Contact: Site 0118         
Local Institution Recruiting
Jerusalem, Israel, 91120
Contact: Site 0121         
Local Institution Recruiting
Ramat Gan, Israel, 5262100
Contact: Site 0120         
Local Institution Recruiting
Zerifin, Israel, 70300
Contact: Site 0119         
Italy
Ospedale S. Donato - Usl 8 Recruiting
Arezzo, Italy, 52100
Contact: Sergio Bracarda, Site 0088         
IRCCS Istituto Nazionale Tumori Recruiting
Milano, Italy, 20133
Contact: Andrea Necchi, Site 0082         
Local Institution Not yet recruiting
Pavia, Italy, 27100
Contact: Site 0087         
Azienda Ospedaliera Universitaria Pisana Recruiting
Pisa, Italy, 56126
Contact: Luca Galli, Site 0084         
Istituto Regina Elena Recruiting
Roma, Italy, 00144
Contact: Francesco Cognetti, Site 0085         
Azienda Ospedaliera S. Camillo Forlanini Terminated
Roma, Italy, 00152
AOUS - Policlinico S.Maria Alle Scotte Recruiting
Siena, Italy, 53100
Contact: Michele Maio, Site 0083         
Japan
Local Institution Recruiting
Akita-shi, Akita, Japan, 0108543
Contact: Site 0142         
Local Institution Recruiting
Hirosaki-shi, Aomori, Japan, 036-8563
Contact: Site 0144         
Local Institution Recruiting
Chiba-shi, Chiba, Japan, 260-8717
Contact: Site 0143         
Local Institution Recruiting
Fukuoka-shi, Fukuoka, Japan, 8128582
Contact: Site 0162         
Local Institution Recruiting
Sapporo-shi, Hokai-do, Japan, 060-8543
Contact: Site 0160         
Local Institution Recruiting
Sapporo-shi, Hokkaido, Japan, 0608648
Contact: Site 0161         
Local Institution Recruiting
Tsukuba-shi, Ibaraki, Japan, 3058576
Contact: Site 0148         
Local Institution Recruiting
Nagasaki-shi, Nagasaki, Japan, 8528501
Contact: Site 0163         
Local Institution Recruiting
Niigata-shi, Niigata, Japan, 9518520
Contact: Site 0150         
Local Institution Recruiting
Okayama-shi, Okayama, Japan, 7000914
Contact: Site 0141         
Local Institution Recruiting
Higashinari-ku, Osaka, Japan, 5378511
Contact: Site 0164         
Local Institution Recruiting
Osaka-Sayama-Shi, Osaka, Japan, 5898511
Contact: Site 0149         
Local Institution Recruiting
Hamamatsu-shi, Shizuoka, Japan, 4313192
Contact: Site 0151         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8603
Contact: Site 0146         
Local Institution Recruiting
Shinjuku-Ku, Tokyo, Japan, 1608582
Contact: Site 0145         
Local Institution Recruiting
Shinjuku-ku, Tokyo, Japan, 1628666
Contact: Site 0147         
Korea, Republic of
Local Institution Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Site 0155         
Local Institution Recruiting
Seoul, Korea, Republic of, 03722
Contact: Site 0154         
Local Institution Recruiting
Seoul, Korea, Republic of, 05505
Contact: Site 0152         
Local Institution Recruiting
Seoul, Korea, Republic of, 06351
Contact: Site 0156         
Mexico
Local Institution Recruiting
Df, Distrito Federal, Mexico, 06720
Contact: Site 0138         
Instituto Nacional De Cancerologia Recruiting
Mexico City, Distrito Federal, Mexico, 14080
Contact: Jose Luis Aguilar Ponce, Site 0034    +525556280400ext37025      
Arke Estudios Clinicos Sa De Cv Recruiting
Mexico, Distrito Federal, Mexico, 06700
Contact: Manuel Magallanes, Site 0116    +5255115833      
Local Institution Recruiting
Mexico, Distrito Federal, Mexico, 14080
Contact: Site 0039         
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44270
Contact: Site 0035         
Hospital Universitario Dr. Jose Eleuterio Gonzalez Recruiting
Monterrey, Nuevo LEON, Mexico, 64460
Contact: Yamil-Alonso Lopez Chuken, Site 0032    +528113521300 00 00000000      
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Site 0069         
Local Institution Recruiting
Maastrict, Netherlands, 6229 HX
Contact: Site 0068         
Local Institution Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Site 0041         
Peru
Local Institution Not yet recruiting
Arequipa, Peru
Contact: Site 0165         
Clinica Internacional sede San Borja Recruiting
Lima, Peru, Lima 41
Contact: Renzo Salas, Site 0043         
Poland
Klinika Onkologii i Radioterapii Recruiting
Gdansk, Poland, 80-952
Contact: Elzbieta Senkus-Konefka, Site 0055    +48583492916      
Regionalny Osrodek Onkologiczny Recruiting
Lodz, Poland, 93-513
Contact: Ewa Kalinka-Warzocha, Site 0057    +48426895600      
Mazovia Szpital Recruiting
Warsaw, Poland, 02-797
Contact: Tomasz Szopinski, Site 0187    +48224035210      
Klinika Urologii i Onkologii Urologicznej Active, not recruiting
Wroclaw, Poland, 50-556
Oddzial Onkologii Klinicznej Recruiting
Wroclaw, Poland, 53-413
Contact: Krzysztof Tupikowski, Site 0186    +48660442252      
Romania
Local Institution Recruiting
Bucuresti, Romania, 021389
Contact: Site 0182         
Local Institution Recruiting
Craiova, Romania, 200347
Contact: Site 0096         
Local Institution Recruiting
Floresti, Romania, 407280
Contact: Site 0078         
Local Institution Recruiting
Timisoara, Timis, Romania, 300239
Contact: Site 0181         
Russian Federation
Local Institution Not yet recruiting
Moscow, Russian Federation, 115478
Contact: Site 0018         
Local Institution Recruiting
Moscow, Russian Federation, 125284
Contact: Site 0140         
Local Institution Recruiting
Saint-Petersburg, Russian Federation, 197758
Contact: Site 0031         
Spain
Local Institution Recruiting
Badalona-barcelona, Spain, 08916
Contact: Site 0067         
Local Institution Recruiting
Barcelona, Spain, 08035
Contact: Site 0066         
Local Institution Recruiting
Madrid, Spain, 28007
Contact: Site 0064         
Local Institution Recruiting
Madrid, Spain, 28034
Contact: Site 0062         
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 0063         
Local Institution Recruiting
Sevilla, Spain, 41013
Contact: Site 0065         
Sweden
Local Institution Recruiting
Lund, Sweden, 221 85
Contact: Site 0105         
Switzerland
Kantonsspital Basel Recruiting
Basel, Switzerland, 4031
Contact: Frank Stenner, Site 0134         
OnkoZentrum Zurich Recruiting
Zuerich, Switzerland, 8038
Contact: Ulf Petrausch, Site 0135         
Taiwan
Local Institution Recruiting
Kaohsiung, Taiwan, 80765
Contact: Site 0158         
Local Institution Recruiting
Taichung, Taiwan, 404
Contact: Site 0159         
Local Institution Recruiting
Taipei, Taiwan, 100
Contact: Site 0153         
United Kingdom
Local Institution Withdrawn
Cardiff, Cardiganshire, United Kingdom, CF142TL
Local Institution Not yet recruiting
London, Greater London, United Kingdom, NW3 2QG
Contact: Site 0017         
Local Institution Recruiting
London, Greater London, United Kingdom, SE1 9RT
Contact: Site 0036         
Local Institution Recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: Site 0025         
Local Institution Recruiting
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Contact: Site 0076         
Local Institution Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Site 0024         
Cancer Research Centre Recruiting
Sheffield, Yorkshire, United Kingdom, S10 2SJ
Contact: Linda Evans, Site 0059    +441142265000      
Local Institution Recruiting
London, United Kingdom, SW3 6JJ
Contact: Site 0114         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02632409     History of Changes
Other Study ID Numbers: CA209-274
2014-003626-40 ( EudraCT Number )
First Submitted: December 14, 2015
First Posted: December 16, 2015
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs