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Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Patients With Untreated Inoperable or Metastatic Urothelial Cancer (CheckMate901)

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.
ClinicalTrials.gov Identifier: NCT03036098
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating patients with previously untreated inoperable or metastatic urothelial cancer.

Condition or disease Intervention/treatment Phase
Urothelial Cancer Biological: nivolumab Biological: ipilimumab Drug: gemcitabine Drug: cisplatin Drug: carboplatin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 897 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : April 26, 2020
Estimated Study Completion Date : December 23, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: Investigational immunotherapy
Specified dose of nivolumab and ipilimumab on specified days
Biological: nivolumab
Specified Dose on Specified Days
Other Names:
  • BMS-936558
  • Opdivo

Biological: ipilimumab
Specified Dose on Specified Days
Other Names:
  • BMS-734016
  • Yervoy

Active Comparator: Arm B: Standard of care chemotherapy
Specified dose of gemcitabine / cisplatin or gemcitabine / carboplatin on specified days
Drug: gemcitabine
Specified Dose on Specified Days

Drug: cisplatin
Specified Dose on Specified Days

Drug: carboplatin
Specified Dose on Specified Days

Experimental: Arm C: Investigational immunotherapy
Specified dose of nivolumab plus gemcitabine-cisplatin followed by nivolumab only on specified days
Biological: nivolumab
Specified Dose on Specified Days
Other Names:
  • BMS-936558
  • Opdivo

Drug: gemcitabine
Specified Dose on Specified Days

Drug: cisplatin
Specified Dose on Specified Days

Active Comparator: Arm D: Standard of care chemotherapy
Specified dose of gemcitabine-cisplatin only on specified days
Drug: gemcitabine
Specified Dose on Specified Days

Drug: cisplatin
Specified Dose on Specified Days




Primary Outcome Measures :
  1. Progression free survival (PFS) in cisplatin-ineligible participants using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: Up to 42 months ]
    Measured by time Only applies to primary study

  2. Overall survival (OS) of cisplatin-ineligible participants [ Time Frame: Up to 42 months ]
    Measured by time Only applies to primary study

  3. PFS based on BICR assessment of nivolumab combined with standard of care (SOC) chemotherapy to SOC chemotherapy in cisplatin-ineligible participants with previously untreated, unresectable or metastatic Urothelial Cancer (UC) [ Time Frame: Up to 42 months ]
    Measured by time Only applies to sub-study


Secondary Outcome Measures :
  1. Progression free survival (PFS) in all participants using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: Up to 42 months ]
    Measured by time

  2. Overall survival (OS) in all participants [ Time Frame: Up to 42 months ]
    Measured by time

  3. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Global Health Status score [ Time Frame: Up to 42 months ]
    Measured by EORTC QLQ-C30

  4. OS in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC. [ Time Frame: Up to 42 months ]
    Measured by time Applies to sub-study



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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Metastatic or inoperable urothelial cancer
  • Must have at least 1 lesion with measurable disease
  • Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
  • No prior systemic chemotherapy treatment in the metastatic setting

Exclusion Criteria:

- Patients with disease that is suitable for local therapy administered with

curative intent

  • Patients with active brain metastases or leptomeningeal metastases
  • Patients with active, known or suspected autoimmune disease
  • Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol defined inclusion/exclusion criteria could apply


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): NCT03036098


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, Alabama
Local Institution Withdrawn
Birmingham, Alabama, United States, 35223
Local Institution Withdrawn
Birmingham, Alabama, United States, 35233
United States, Alaska
Alaska Urological Institute dba Alaska Clinical Research Center Recruiting
Anchorage, Alaska, United States, 99503
Contact: William Clark, Site 0001    907-276-1455      
United States, Arkansas
Local Institution Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
VA of Central California Health Care System Recruiting
Fresno, California, United States, 93703
Contact: Subramanyeswara Arekapudi, Site 0115    559-225-6100      
St Joseph Heritage Healthcare Recruiting
Santa Rosa, California, United States, 95403
Contact: Thomas Stanton, Site 0078    707-521-3830      
United States, Florida
Boca Raton Regional Hospital Recruiting
Boca Raton, Florida, United States, 33486
Contact: Lloyd Berkowitz, Site 0051         
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Georges Azzi, Site 0087    954-267-7750      
Cancer Specialists of North FL Recruiting
Jacksonville, Florida, United States, 32207
Contact: Bijoy Telivala, Site 0062    904-363-7462      
United States, Georgia
University Cancer Blood Ctr Recruiting
Athens, Georgia, United States, 30607
Contact: Petros Nikolinakos, Site 0004    706-353-2990      
Lewis Hall Singletary Oncology Center Recruiting
Thomasville, Georgia, United States, 31792
Contact: Josh Simmons, Site 0033    229-584-5417      
United States, Illinois
University Of Illinois At Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: David Peace, Site 0046    312-996-1588      
United States, Iowa
Local Institution Withdrawn
Iowa City, Iowa, United States, 55242
United States, Louisiana
Ochsner Clinic Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Marc Matrana, Site 0117    504-703-2652      
United States, Massachusetts
Beth Israel Deaconess Med Ctr Recruiting
Boston, Massachusetts, United States, 02215
Contact: Guru Sonpavde, Site 0073         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Guru Sonpavde, Site 0056    617-582-7334      
Milford Regional Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Guru Sonpavde, Site 0208         
South Shore Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Guru Sonpavde, Site 0207         
United States, Michigan
St. Joseph Mercy Hospital Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Tareq Al Baghdadi, Site 0063    734-712-5674      
United States, Minnesota
Ridges Cancer Clinic Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Gautam Jha, Site 0002    952-836-3608      
United States, Mississippi
Hattiesburg Clinic Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: John Hrom, Site 0105    601-288-2495      
United States, Missouri
St Lukes Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Jacob Smeltzer, Site 0032    816-932-2677      
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Vivek Arora, Site 0095    314-747-1343      
United States, Nebraska
GU Research Network, LLC Recruiting
Omaha, Nebraska, United States, 68130
Contact: Luke Nordquist, Site 0161    402-991-8468      
United States, New Hampshire
Nh Hematology - Oncology Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Douglas Weckstein, Site 0057    603-622-6484      
United States, New Mexico
University Of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Richard Lauer, Site 0084    505-272-7813      
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Gurkamal Chatta, Site 0083         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mary O'Keeffe, Site 0014    516-663-3115      
Icahn School Of Medicine At Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Matthew Galsky, Site 0072    212-824-7117      
Local Institution Withdrawn
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Harrison, Site 0116    919-681-9822      
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Amir Mortazavi, Site 0082         
United States, Oregon
Providence Portland Med Ctr Recruiting
Portland, Oregon, United States, 97213
Contact: Brendan Curti, Site 0104    503-215-2604      
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212-0000
Contact: Shifeng Mao, Site 0013    412-359-6452      
United States, Texas
Local Institution Withdrawn
Houston, Texas, United States, 77030
United States, Utah
Local Institution Withdrawn
Salt Lake City, Utah, United States, 84112
United States, Washington
Seattle Cancer Care Alliance Recruiting
Kirkland, Washington, United States, 98034
Contact: Eric Dean, Site 0086    425-899-3977      
United States, Wisconsin
Local Institution Withdrawn
Milwaukee, Wisconsin, United States, 53226
Argentina
Instituto Medico Especializado Alexander Fleming Recruiting
Capital Federal, Buenos Aires, Argentina, 1426
Contact: Juan Sade, Site 0005    +541132218900      
Hospital Privado De Comunidad Recruiting
Mar Del Plata, Buenos Aires, Argentina, 7600
Contact: Marcos Flores, Site 0007    +54223499000      
Clinica Viedma S.A. Recruiting
Viedma, RIO Negro, Argentina, 8500
Contact: Ruben Kowalyszyn, Site 0008    +542920424417      
Centro De Diagnostico Urologico S.R.L. Recruiting
Buenos Aires, Argentina, 1120
Contact: Juan Ignacio Hernandez Moran, Site 0009    +541149642424      
Local Institution Recruiting
Cordoba, Argentina, 5000
Contact: Site 0134         
Clinica Privada Universitaria Reina Fabiola Recruiting
Cordoba, Argentina, 5004
Contact: Santiago Bella, Site 0006    +543514142121      
Australia, New South Wales
Local Institution Withdrawn
Darlinghurst, New South Wales, Australia, 2010
Local Institution Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Site 0096         
Local Institution Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 0099         
Australia, Queensland
Local Institution Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Site 0188         
Local Institution Recruiting
Tugun, Queensland, Australia, 4224
Contact: Site 0120         
Australia, Victoria
Local Institution Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 0101         
Australia, Western Australia
Local Institution Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 0100         
Brazil
Hospital Sirio Libanes Recruiting
Brasilia, Distrito Federal, Brazil, 70200-730
Contact: Rodrigo Medeiros, Site 0017    +556130448854      
Associacao Hospital de Caridade Ijui Recruiting
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Contact: Fabio Franke, Site 0021    +555591592101      
Hospital Sao Vicente De Paulo Recruiting
Passo Fundo, RIO Grande DO SUL, Brazil, 99010-080
Contact: Nicolas Lazaretti, Site 0119    +555421034130      
Hospital Sao Lucas Da Pucrs Recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
Contact: Andre Fay, Site 0020    +555181181602      
Centro de Pesquisas Oncologicas de Santa Catarina-CEPON Recruiting
Florianopolis, Santa Catarina, Brazil, 88034-000
Contact: Marcelo Pereira Freitas, Site 0016    +554833311553      
Hospital De Cancer De Barretos Recruiting
Barretos, SAO Paulo, Brazil, 14784-400
Contact: Luis Eduardo Zucca, Site 0018    +551733216638      
Hospital De Base Da Faculdade De Medicina De Rio Preto Recruiting
Sao Jose Do Rio Preto, SAO Paulo, Brazil, 15090-000
Contact: Gustavo Girotto, Site 0019    +551732015054      
Local Institution Withdrawn
Sao Paulo, Brazil, 01509-900
Canada, Nova Scotia
Nova Scotia Health Authority QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Robyn Macfarlane, Site 0053    9024736106      
Canada, Ontario
London Regional Cancer Program, London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Eric Winquist, Site 0064    5196858640      
Canada, Quebec
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Michel Pavic, Site 0052    819346111012811      
Canada
CHU de Quebec - L'Hotel-Dieu de Quebec Recruiting
Quebec, Canada, G1R 2J6
Contact: Louis Lacombe, Site 0054    4185254444      
Chile
Local Institution Withdrawn
Santiago, Metropolitana, Chile
Centro Internacional de Estudios Clinicos Recruiting
Recoleta, Santiago DE Chile, Chile
Contact: Osvaldo Aren Frontera, Site 0010    +5627357954      
Oncocentro Apys Recruiting
Vina Del Mar, Valparaiso, Chile, 2520612
Contact: Alejandro Andres Acevedo Gaete, Site 0012    +56322323781      
Local Institution Recruiting
Vitacura, Chile
Contact: Site 0106         
China, Beijing
Local Institution Recruiting
Beijing, Beijing, China, 100001
Contact: Site 0171         
Local Institution Recruiting
Beijing, Beijing, China, 100034
Contact: Site 0169         
China, Chongqing
Local Institution Recruiting
Chongqing, Chongqing, China, 400030
Contact: Site 0182         
China, Hubei
Local Institution Recruiting
Wuhan, Hubei, China, 430030
Contact: Site 0180         
China, Jiangsu
Local Institution Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Site 0177         
Local Institution Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Site 0176         
China, Jilin
Local Institution Recruiting
Changchun, Jilin, China, 130021
Contact: Site 0186         
China, Shanghai
Local Institution Recruiting
Shanghai, Shanghai, China, 200025
Contact: Site 0167         
Local Institution Recruiting
Shanghai, Shanghai, China, 200032
Contact: Site 0162         
Local Institution Recruiting
Shanghai, Shanghai, China, 200040
Contact: Site 0163         
China, Sichuan
Local Institution Recruiting
Chengdu, Sichuan, China, 610041
Contact: Site 0184         
China, Zhejiang
Local Institution Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Site 0174         
Local Institution Recruiting
Hangzhou, Zhejiang, China
Contact: Site 0173         
China
Local Institution Recruiting
Beijing, China, 100083
Contact: Site 0170         
Local Institution Recruiting
Hangzhou, China, 310014
Contact: Site 0172         
Local Institution Recruiting
Shanghai, China, 200032
Contact: Site 0164         
Czechia
Klinika komplexni onkologicke pece Recruiting
Brno, Czechia, 656 53
Contact: Alexandr Poprach, Site 0160    +420543132216      
Klinika onkologie a radioterapie Recruiting
Hradec Kralove, Czechia, 500 05
Contact: Jindrich Kopecky, Site 0152    +420495834666      
Denmark
Local Institution Recruiting
Aalborg, Denmark, 9100
Contact: Site 0190         
Local Institution Recruiting
Herlev, Denmark, 2730
Contact: Site 0196         
Finland
Local Institution Recruiting
Helsinki, Finland, 00029
Contact: Site 0060         
France
Local Institution Recruiting
Lille, France, 59000
Contact: Site 0089         
Local Institution Recruiting
Marseille Cedex 9, France, 13273
Contact: Site 0088         
Local Institution Recruiting
Nimes Cedex 09, France, 30029
Contact: Site 0091         
Local Institution Recruiting
Saint Priest En Jarez, France, 42271
Contact: Site 0090         
Local Institution Recruiting
Suresnes, France, 92151
Contact: Site 0092         
Local Institution Recruiting
Tours Cedex, France, 37044
Contact: Site 0093         
Local Institution Recruiting
Villejuif, France, 94805
Contact: Site 0094         
Germany
Universitat Dresden Terminated
Dresden, Germany, 01307
Universitaetsklinikum Essen Recruiting
Essen, Germany, 45147
Contact: Martin Schuler, Site 0048    +492017232000      
Medizinische Universitaetsklinik Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Cornelius Waller, Site 0047    +4976127073610      
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Contact: Christian Wuelfing, Site 0049    +49401818818635      
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Florian Imkamp, Site 0037    +495115323556      
Universitaetsklinikum Jena Recruiting
Jena, Germany, 07747
Contact: Marc-Oliver Grimm, Site 0041    +4936419329956      
Local Institution Withdrawn
Muenchen, Germany, 81675
Klinikum Nuernberg Nord, Urologische Klinik Recruiting
Nuernberg, Germany, 90419
Contact: Marinela Augustin, Site 0038    +499113983085      
Uniklinik Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Jens Bedke, Site 0040    +4970712987235      
Kliniken Nordoberpfalz AG Recruiting
Weiden, Germany, 92637
Contact: Thomas Bschleipfer, Site 0114    +499613033307      
Univ. Klinikum Wuerzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Hubert Kuebler, Site 0039    +4993120132001      
Greece
Alexandra General Hospital Recruiting
Athens, Greece, 11528
Contact: Aristotelis Bamias, Site 0102    +302132162845      
Ioannina University Hospital Recruiting
Ioannina, Greece, 45500
Contact: George Pentheroudakis, Site 0103    +302651099394      
Hungary
Local Institution Not yet recruiting
Budapest, Hungary, 1122
Contact: Site 0029         
Local Institution Not yet recruiting
Budapest, Hungary, 1145
Contact: Site 0043         
Local Institution Not yet recruiting
Debrecen, Hungary
Contact: Site 0028         
Local Institution Not yet recruiting
Miskolc, Hungary, 3526
Contact: Site 0035         
Israel
Local Institution Recruiting
Kfar Saba, Israel, 44281
Contact: Site 0199         
Local Institution Recruiting
Ramat Gan, Israel, 52621
Contact: Site 0198         
Italy
Ospedale S. Donato - Usl 8 Recruiting
Arezzo, Italy, 52100
Contact: Alketa Hamzaj, Site 0108    +3905752551 0000 0000      
Ospedale Per Gli Infermi Recruiting
Faenza, Italy, 48018
Contact: Francesco Carrozza, Site 0197    +390546601111 0000 000000      
Istituto Romagnolo Per Lo Studio E La Cura Dei Tumori Recruiting
Forli, Italy, 47014
Contact: Ugo De Giorgi, Site 0111    +390543739100 0000 000000      
Ospedale Della Misericordia Grosseto Recruiting
Grosseto, Italy, 58100
Contact: Carmelo Bengala, Site 0109    +390564485034 0000 000000      
IRCCS Istituto Nazionale Tumori Milano Recruiting
Milano, Italy, 20133
Contact: Andrea Necchi, Site 0107    +390223901 00 00000      
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli Recruiting
Napoli, Italy, 80131
Contact: Giacomo Carteni, Site 0110    +390817471111 000 000 0000      
Japan
Local Institution Recruiting
Hirosaki-shi, Aomori, Japan, 036-8563
Contact: Site 0136         
Local Institution Recruiting
Chiba-shi, Chiba, Japan, 260-8717
Contact: Site 0135         
Local Institution Recruiting
Matsuyama-shi, Ehime, Japan, 7910280
Contact: Site 0147         
Local Institution Recruiting
Fukuoka-shi, Fukuoka, Japan, 8128582
Contact: Site 0140         
Local Institution Recruiting
Sapporo-city, Hokkaido, Japan, 0608543
Contact: Site 0146         
Local Institution Recruiting
Tsukuba-shi, Ibaraki, Japan, 3058576
Contact: Site 0150         
Local Institution Recruiting
Kita-Gun, Kagawa, Japan, 7610793
Contact: Site 0137         
Local Institution Recruiting
Niigata-shi, Niigata, Japan, 9518520
Contact: Site 0141         
Local Institution Recruiting
Okayama-shi, Okayama, Japan, 7008558
Contact: Site 0143         
Local Institution Recruiting
Osaka-shi, Osaka, Japan, 5418567
Contact: Site 0144         
Local Institution Recruiting
Osakasayama, Osaka, Japan, 589-8511
Contact: Site 0139         
Local Institution Recruiting
Takatsuki-shi, Osaka, Japan, 5698686
Contact: Site 0145         
Local Institution Recruiting
Hamamatsu-shi, Shizuoka, Japan, 431-3192
Contact: Site 0201         
Local Institution Recruiting
Arakawa-ku,tokyo, Tokyo, Japan, 1168567
Contact: Site 0149         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1138519
Contact: Site 0148         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1138602
Contact: Site 0142         
Local Institution Recruiting
Shinjuku-Ku, Tokyo, Japan, 1608582
Contact: Site 0138         
Local Institution Recruiting
Ube City, Yamaguchi, Japan, 755-8505
Contact: Site 0200         
Korea, Republic of
Local Institution Recruiting
Goyang-si, Korea, Republic of, 10408
Contact: Site 0125         
Local Institution Recruiting
Seongnam-si, Korea, Republic of, 13620
Contact: Site 0126         
Local Institution Recruiting
Seoul, Korea, Republic of, 03080
Contact: Site 0124         
Local Institution Recruiting
Seoul, Korea, Republic of, 03722
Contact: Site 0151         
Local Institution Recruiting
Seoul, Korea, Republic of, 05505
Contact: Site 0128         
Local Institution Recruiting
Seoul, Korea, Republic of, 06351
Contact: Site 0127         
Mexico
Comite Mexicano para la Prevenion de la Osteoporosis A.C. Recruiting
Ciudad de Mexico, Distrito Federal, Mexico, 06100
Contact: Daniel Motola Kuba, Site 0129         
Local Institution Not yet recruiting
Mexico City, Distrito Federal, Mexico, 07760
Contact: Site 0154         
Local Institution Not yet recruiting
Tlalpan, Distrito Federal, Mexico, 14080
Contact: Site 0130         
Centro Universitario Contra el Cancer UANL Recruiting
Monterrey, Nuevo LEON, Mexico, 64460
Contact: Yamil-Alonso Lopez Chuken, Site 0131         
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Site 0022         
Local Institution Recruiting
Enschede, Netherlands, 7512KZ
Contact: Site 0055         
Local Institution Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Site 0024         
Local Institution Recruiting
Leeuwarden, Netherlands, 8934 AD
Contact: Site 0026         
Norway
Local Institution Recruiting
Bergen, Norway, 5021
Contact: Site 0074         
Local Institution Recruiting
Lorenskog, Norway, 1478
Contact: Site 0081         
Peru
Instituto Nacional De Enfermedades Neoplasicas Recruiting
Lima, Peru, 34
Contact: Silvia Neciosup, Site 0030         
Clinica El Golf Recruiting
Lima, Peru, Lima 27
Contact: Ruth Huaringa Leiva, Site 0031         
Poland
Ambulatorium Chemioterapii Recruiting
Bydgoszcz, Poland, 85-796
Contact: Bogdan Zurawski, Site 0189    +48523743029      
Local Institution Recruiting
Koszalin, Poland, 75-581
Contact: Site 0205         
Klinika Nowotworow Ukladu Moczowego Centrum Onkologii - Inst Recruiting
Warszawa, Poland, 02-781
Contact: Pawel Wiechno, Site 0202    +48501326278      
Romania
Local Institution Not yet recruiting
Cluj-Napoca, Romania, 400015
Contact: Site 0191         
Local Institution Not yet recruiting
Craiova, Romania, 200347
Contact: Site 0187         
Russian Federation
Local Institution Not yet recruiting
Moscow, Russian Federation, 115478
Contact: Site 0122         
Local Institution Recruiting
Moscow, Russian Federation, 117997
Contact: Site 0123         
Local Institution Recruiting
Moscow, Russian Federation, 125367
Contact: Site 0211         
Local Institution Not yet recruiting
Novosibirsk, Russian Federation, 630099
Contact: Site 0206         
Local Institution Recruiting
St Petersburg, Russian Federation, 198255
Contact: Site 0121         
Singapore
Local Institution Recruiting
Singapore, Singapore, 169610
Contact: Site 0192         
Spain
Comp. Hosp. Univ. A Coruna Recruiting
A Coruna, Spain, 15006
Contact: Aurea Molina Diaz, Site 0070         
Hospital Santa Creu I Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Jose Pablo Maroto Rey, Site 0068         
Hospital Universitario Ramon Y Cajal Recruiting
Madrid, Spain, 28034
Contact: Teresa Alonso Gordoa, Site 0065         
Hosp Univer 12 De Octubre Recruiting
Madrid, Spain, 28041
Contact: Daniel Castellano, Site 0066         
H. U. Marques de Valdecilla Recruiting
Santander, Spain, 39008
Contact: Ignacio Duran, Site 0209         
Hospital Universitario Virgen Del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Begona Perez Valderrama, Site 0067         
Instituto Valenciano De Oncologia Recruiting
Valencia, Spain, 46009
Contact: Miguel Climent, Site 0069         
Sweden
Local Institution Recruiting
Jonkoping, Sweden, 551 85
Contact: Site 0075         
Local Institution Recruiting
Linkoping, Sweden, 581 85
Contact: Site 0059         
Local Institution Recruiting
Lund, Sweden, 221 85
Contact: Site 0058         
Switzerland
Kantonsspital Baden Recruiting
Baden, Switzerland, 5404
Contact: Andreas Erdmann, Site 0061    +41564862765      
Kantonsspital Graubuenden Recruiting
Chur, Switzerland, 7000
Contact: Richard Cathomas, Site 0042    +41812566860      
Taiwan
Local Institution Recruiting
Kaohsiung, Taiwan, 883
Contact: Site 0156         
Local Institution Recruiting
Taichung, Taiwan, 40705
Contact: Site 0159         
Local Institution Recruiting
Taipei, Taiwan, 100
Contact: Site 0158         
Local Institution Recruiting
Taipei, Taiwan, 11217
Contact: Site 0155         
Local Institution Recruiting
Taoyuan, Taiwan, 333
Contact: Site 0157         
Turkey
Local Institution Not yet recruiting
Ankara, Turkey, 06590
Contact: Site 0194         
Local Institution Not yet recruiting
Istanbul, Turkey, 34300
Contact: Site 0204         
Local Institution Not yet recruiting
Izmir, Turkey, 35340
Contact: Site 0193         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03036098     History of Changes
Other Study ID Numbers: CA209-901
2016-003881-14 ( EudraCT Number )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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

Additional relevant MeSH terms:
Gemcitabine
Nivolumab
Cisplatin
Carboplatin
Antineoplastic Agents
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs