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BRIEF TITLE: 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

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


  • Org Study ID: CA209-901
  • Secondary ID: 2016-003881-14
  • NCT ID: NCT03036098
  • NCT Alias:
  • Sponsor: Bristol-Myers Squibb - Industry
  • Source: Bristol-Myers Squibb

Description

To learn more about this study, visit: https://www.bmsstudyconnect.com/us/en/clinical-trials/NCT03036098.html

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.

Overal Status Start Date Phase Study Type
Recruiting March 24, 2017 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Overall survival (OS) in cisplatin-ineligible randomized participants

Primary Outcome 1 - Time Frame: Up to 55 months

Primary Outcome 2 - Measure: OS in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC)

Primary Outcome 2 - Time Frame: Up to 52 months

Primary Outcome 3 - Measure: PFS by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic Urothelial Carcinoma( UC)

Primary Outcome 3 - Time Frame: Up to 55 months

Condition:

  • Urothelial Cancer

Eligibility

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
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
Birmingham, Alabama 35223
United States
Withdrawn
Local Institution
Birmingham, Alabama 35233
United States
Withdrawn
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska 99503
United States
Recruiting William Clark, Site 0001
907-276-1455
Local Institution
Little Rock, Arkansas 72205
United States
Withdrawn
VA of Central California Health Care System
Fresno, California 93703
United States
Recruiting Subramanyeswara Arekapudi, Site 0115
559-225-6100
St Joseph Heritage Healthcare
Santa Rosa, California 95403
United States
Recruiting Thomas Stanton, Site 0078
707-521-3830
Boca Raton Regional Hospital
Boca Raton, Florida 33486
United States
Recruiting Lloyd Berkowitz, Site 0051

Holy Cross Hospital
Fort Lauderdale, Florida 33308
United States
Recruiting Georges Azzi, Site 0087
954-267-7750
Cancer Specialists of North FL
Jacksonville, Florida 32207
United States
Recruiting Bijoy Telivala, Site 0062
904-363-7462
University Cancer Blood Ctr
Athens, Georgia 30607
United States
Recruiting Petros Nikolinakos, Site 0004
706-353-2990
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
Thomasville, Georgia 31792
United States
Recruiting Josh Simmons, Site 0033
229-584-5417
University Of Illinois At Chicago
Chicago, Illinois 60612
United States
Recruiting David Peace, Site 0046
312-996-1588
Local Institution
Iowa City, Iowa 55242
United States
Withdrawn
Ochsner Clinic
New Orleans, Louisiana 70121
United States
Recruiting Marc Matrana, Site 0117
504-703-2652
Beth Israel Deaconess Med Ctr
Boston, Massachusetts 02215
United States
Recruiting Guru Sonpavde, Site 0073

Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting Guru Sonpavde, Site 0056
617-582-7334
Milford Regional Medical Center
Boston, Massachusetts 02215
United States
Recruiting Guru Sonpavde, Site 0208

South Shore Hospital Cancer Center
Boston, Massachusetts 02215
United States
Recruiting Guru Sonpavde, Site 0207

St. Joseph Mercy Hospital
Ypsilanti, Michigan 48197
United States
Recruiting Tareq Al Baghdadi, Site 0063
734-712-5674
Ridges Cancer Clinic
Burnsville, Minnesota 55337
United States
Recruiting Gautam Jha, Site 0002
952-836-3608
Hattiesburg Clinic
Hattiesburg, Mississippi 39401
United States
Recruiting John Hrom, Site 0105
601-288-2495
St Lukes Hospital
Kansas City, Missouri 64111
United States
Recruiting Jacob Smeltzer, Site 0032
816-932-2677
Washington University School OF Medicine-Siteman Cancer Center
Saint Louis, Missouri 63110
United States
Recruiting Vivek Arora, Site 0095
314-747-1343
GU Research Network, LLC
Omaha, Nebraska 68130
United States
Recruiting Luke Nordquist, Site 0161
402-991-8468
NH Oncology-Hematology, PA
Hooksett, New Hampshire 03106
United States
Recruiting Douglas Weckstein, Site 0057
603-622-6484
University Of New Mexico
Albuquerque, New Mexico 87131
United States
Recruiting Richard Lauer, Site 0084
505-272-7813
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting Gurkamal Chatta, Site 0083

NYU Winthrop Hospital Dept of Oncology/Hematology
Mineola, New York 11501
United States
Recruiting Mary O'Keeffe, Site 0014
516-663-3115
Icahn School Of Medicine At Mount Sinai
New York, New York 10029
United States
Recruiting Matthew Galsky, Site 0072
212-824-7117
Local Institution
New York, New York 10065
United States
Withdrawn
Duke University Medical Center
Durham, North Carolina 27710
United States
Recruiting Michael Harrison, Site 0116
919-681-9822
The Ohio State University
Columbus, Ohio 43210
United States
Recruiting Amir Mortazavi, Site 0082

Providence Portland Med Ctr
Portland, Oregon 97213
United States
Recruiting Brendan Curti, Site 0104
503-215-2604
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
Recruiting Shifeng Mao, Site 0013
412-359-6452
Local Institution
Houston, Texas 77030
United States
Withdrawn
Local Institution
Salt Lake City, Utah 84112
United States
Withdrawn
Seattle Cancer Care Alliance
Kirkland, Washington 98034
United States
Recruiting Eric Dean, Site 0086
425-899-3977
Local Institution
Milwaukee, Wisconsin 53226
United States
Withdrawn
Instituto Medico Especializado Alexander Fleming
Capital Federal, Buenos Aires 1426
Argentina
Recruiting Juan Sade, Site 0005
+541132218900
Hospital Privado De Comunidad
Mar Del Plata, Buenos Aires 7600
Argentina
Recruiting Marcos Flores, Site 0007
+54223499000
Clinica Viedma S.A.
Viedma, RIO Negro 8500
Argentina
Recruiting Ruben Kowalyszyn, Site 0008
+542920424417
Centro De Diagnostico Urologico S.R.L.
Buenos Aires, 1120
Argentina
Recruiting Juan Ignacio Hernandez Moran, Site 0009
+541149642424
Instituto Oncologico De Cordoba
Cordoba, 5000
Argentina
Recruiting Martin Richardet, Site 0134
+543514601544
Clinica Privada Universitaria Reina Fabiola
Cordoba, 5004
Argentina
Recruiting Santiago Bella, Site 0006
+543514142121
Local Institution
Darlinghurst, New South Wales 2010
Australia
Withdrawn
Local Institution
Waratah, New South Wales 2298
Australia
Recruiting Site 0096

Local Institution
Westmead, New South Wales 2145
Australia
Recruiting Site 0099

Local Institution
South Brisbane, Queensland 4101
Australia
Recruiting Site 0188

Local Institution
Tugan, Queensland 4224
Australia
Recruiting Site 0120

Local Institution
Heidelberg, Victoria 3084
Australia
Recruiting Site 0101

Local Institution
Nedlands, Western Australia 6009
Australia
Recruiting Site 0100

Hospital Sirio Libanes
Brasilia, Distrito Federal 70200-730
Brazil
Recruiting Rodrigo Medeiros, Site 0017
+556130448854
Associacao Hospital de Caridade Ijui
Ijui, RIO Grande DO SUL 98700-000
Brazil
Recruiting Fabio Franke, Site 0021
+555591592101
Hospital Sao Vicente De Paulo
Passo Fundo, RIO Grande DO SUL 99010-080
Brazil
Recruiting Nicolas Lazaretti, Site 0119
+555421034130
Hospital Sao Lucas Da Pucrs
Porto Alegre, RIO Grande DO SUL 90610-000
Brazil
Recruiting Andre Fay, Site 0020
+555181181602
Centro de Pesquisas Oncologicas de Santa Catarina-CEPON
Florianopolis, Santa Catarina 88034-000
Brazil
Recruiting Marcelo Pereira Freitas, Site 0016
+554833311553
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos, SAO Paulo 14784-400
Brazil
Recruiting Luis Eduardo Zucca, Site 0018
+551733216638
Hospital De Base Da Faculdade De Medicina De Rio Preto
Sao Jose Do Rio Preto, SAO Paulo 15090-000
Brazil
Recruiting Gustavo Girotto, Site 0019
+551732015054
Local Institution
Sao Paulo, 01509-900
Brazil
Withdrawn
Nova Scotia Health Authority QEII Health Sciences Centre
Halifax, Nova Scotia B3H 2Y9
Canada
Recruiting Robyn Macfarlane, Site 0053
9024736106
London Regional Cancer Program, London Health Sciences Centre
London, Ontario N6A 4L6
Canada
Active, not recruiting
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
Sherbrooke, Quebec J1H 5N4
Canada
Recruiting Michel Pavic, Site 0052
819346111012811
CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec, G1R 2J6
Canada
Recruiting Louis Lacombe, Site 0054
4185254444
Local Institution
Santiago, Metropolitana
Chile
Withdrawn
Centro Internacional de Estudios Clinicos
Recoleta, Santiago DE Chile
Chile
Recruiting Mauricio Burotto, Site 0010
+5627357954
Oncocentro Apys
Vina del Mar, Valparaiso 2520598
Chile
Recruiting Alejandro Andres Acevedo Gaete, Site 0012
+56322323781
Local Institution
Vitacura,
Chile
Recruiting Site 0106

Local Institution
Beijing, Beijing 100001
China
Recruiting Site 0171

Local Institution
Beijing, Beijing 100034
China
Recruiting Site 0169

Local Institution
Chongqing, Chongqing 400030
China
Recruiting Site 0182

Local Institution
Wuhan, Hubei 430030
China
Recruiting Site 0180

Local Institution
Nanjing, Jiangsu 210000
China
Recruiting Site 0177

Local Institution
Nanjing, Jiangsu 210008
China
Recruiting Site 0176

Local Institution
Nanjng, Jiangsu
China
Recruiting Site 0175

Local Institution
Changchun, Jilin 130021
China
Recruiting Site 0186

Local Institution
Shanghai, Shanghai 200025
China
Recruiting Site 0167

Local Institution
Shanghai, Shanghai 200032
China
Recruiting Site 0162

Local Institution
Shanghai, Shanghai 200040
China
Recruiting Site 0163

Local Institution
Chengdu, Sichuan 610041
China
Recruiting Site 0184

Local Institution
Hangzhou, Zhejiang 310009
China
Recruiting Site 0174

Local Institution
Hangzhou, Zhejiang 310014
China
Recruiting Site 0172

Local Institution
Beijing, 100083
China
Recruiting Site 0170

Local Institution
Hangzhou, 310022
China
Recruiting Site 0173

Local Institution
Shanghai, 200032
China
Recruiting Site 0164

Klinika komplexni onkologicke pece
Brno, 656 53
Czechia
Recruiting Alexandr Poprach, Site 0160
+420543132216
Klinika onkologie a radioterapie
Hradec Kralove, 500 05
Czechia
Recruiting Jindrich Kopecky, Site 0152
+420495834666
Local Institution
Aalborg, 9100
Denmark
Recruiting Site 0190

Local Institution
Herlev, 2730
Denmark
Recruiting Site 0196

Local Institution
Helsinki, 00029
Finland
Terminated
Local Institution
Lille, 59000
France
Recruiting Site 0089

Local Institution
Marseille Cedex 9, 13273
France
Recruiting Site 0088

Local Institution
Nimes Cedex 09, 30029
France
Recruiting Site 0091

Local Institution
Saint Priest En Jarez, 42271
France
Recruiting Site 0090

Local Institution
Suresnes, 92151
France
Recruiting Site 0092

Local Institution
Tours Cedex, 37044
France
Recruiting Site 0093

Local Institution
Villejuif, 94805
France
Recruiting Site 0094

Universitat Dresden
Dresden, 01307
Germany
Terminated
Universitaetsklinikum Essen
Essen, 45147
Germany
Recruiting Martin Schuler, Site 0048
+492017232000
Medizinische Universitaetsklinik Freiburg
Freiburg, 79106
Germany
Recruiting Cornelius Waller, Site 0047
+4976127073610
Asklepios Klinik Altona
Hamburg, 22763
Germany
Recruiting Christian Wuelfing, Site 0049
+49401818818635
Medizinische Hochschule Hannover
Hannover, 30625
Germany
Recruiting Florian Imkamp, Site 0037
+495115323556
Universitaetsklinikum Jena
Jena, 07747
Germany
Recruiting Marc-Oliver Grimm, Site 0041
+4936419329956
Universitaetsklinikum Mannheim
Mannheim, 68167
Germany
Recruiting Philipp Nuhn, Site 0213
+496213834973
Local Institution
Muenchen, 81675
Germany
Withdrawn
Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg, 90419
Germany
Recruiting Marinela Augustin, Site 0038
+499113983085
Uniklinik Tuebingen
Tuebingen, 72076
Germany
Recruiting Jens Bedke, Site 0040
+4970712987235
Kliniken Nordoberpfalz AG
Weiden, 92637
Germany
Recruiting Thomas Bschleipfer, Site 0114
+499613033307
Univ. Klinikum Wuerzburg
Wuerzburg, 97080
Germany
Recruiting Hubert Kuebler, Site 0039
+4993120132001
Alexandra General Hospital
Athens, 11528
Greece
Recruiting Aristotelis Bamias, Site 0102
+302132162845
Ioannina University Hospital
Ioannina, 45500
Greece
Recruiting George Pentheroudakis, Site 0103
+302651099394
Local Institution
Budapest, 1122
Hungary
Not yet recruiting Site 0029

Local Institution
Budapest, 1145
Hungary
Not yet recruiting Site 0043

Local Institution
Debrecen,
Hungary
Not yet recruiting Site 0028

Local Institution
Miskolc, 3526
Hungary
Not yet recruiting Site 0035

Local Institution
Kfar Saba, 44281
Israel
Recruiting Site 0199

Local Institution
Ramat Gan, 52621
Israel
Recruiting Site 0198

Ospedale S. Donato - Usl 8
Arezzo, 52100
Italy
Recruiting Alketa Hamzaj, Site 0108
+3905752551 0000 0000
Ospedale Per Gli Infermi
Faenza, 48018
Italy
Recruiting Francesco Carrozza, Site 0197
+390546601111 0000 000000
IRST Meldola
Forli, 47014
Italy
Recruiting Ugo De Giorgi, Site 0111
+390543739100 0000 000000
Ospedale Della Misericordia Grosseto
Grosseto, 58100
Italy
Recruiting Carmelo Bengala, Site 0109
+390564485034 0000 000000
IRCCS Istituto Nazionale Tumori Milano
Milano, 20133
Italy
Recruiting Andrea Necchi, Site 0107
+390223901 00 00000
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
Napoli, 80131
Italy
Recruiting Ferdinando Riccardi, Site 0110
+390817471111 000 000 0000
Local Institution
Hirosaki-shi, Aomori 036-8563
Japan
Active, not recruiting
Local Institution
Chiba-shi, Chiba 260-8717
Japan
Active, not recruiting
Local Institution
Matsuyama-shi, Ehime 7910280
Japan
Active, not recruiting
Local Institution
Fukuoka-shi, Fukuoka 8128582
Japan
Active, not recruiting
Local Institution
Sapporo-city, Hokkaido 0608543
Japan
Active, not recruiting
Local Institution
Tsukuba-shi, Ibaraki 3058576
Japan
Active, not recruiting
Local Institution
Morioka-shi, Iwate 0208505
Japan
Completed
Local Institution
Kita-Gun, Kagawa 7610793
Japan
Active, not recruiting
Local Institution
Niigata-shi, Niigata 9518520
Japan
Active, not recruiting
Local Institution
Okayama-shi, Okayama 7008558
Japan
Completed
Local Institution
Osaka-shi, Osaka 5418567
Japan
Active, not recruiting
Local Institution
Osakasayama, Osaka 589-8511
Japan
Active, not recruiting
Local Institution
Takatsuki-shi, Osaka 5698686
Japan
Active, not recruiting
Local Institution
Hamamatsu-shi, Shizuoka 431-3192
Japan
Active, not recruiting
Local Institution
Arakawa-ku,tokyo, Tokyo 1168567
Japan
Active, not recruiting
Local Institution
Bunkyo-ku, Tokyo 1138519
Japan
Active, not recruiting
Local Institution
Bunkyo-ku, Tokyo 1138602
Japan
Active, not recruiting
Local Institution
Shinjuku-Ku, Tokyo 1608582
Japan
Active, not recruiting
Local Institution
Wakayama-shi, Wakayama 6418510
Japan
Active, not recruiting
Local Institution
Ube City, Yamaguchi 755-8505
Japan
Active, not recruiting
Local Institution
Goyang-si, 10408
Korea, Republic of
Active, not recruiting
Local Institution
Seongnam-si, 13620
Korea, Republic of
Active, not recruiting
Local Institution
Seoul, 03080
Korea, Republic of
Active, not recruiting
Local Institution
Seoul, 03722
Korea, Republic of
Completed
Local Institution
Seoul, 05505
Korea, Republic of
Active, not recruiting
Local Institution
Seoul, 06351
Korea, Republic of
Active, not recruiting
Comite Mexicano para la Prevenion de la Osteoporosis A.C.
Ciudad de Mexico, Distrito Federal 06100
Mexico
Recruiting Daniel Motola Kuba, Site 0129

Hospital Juarez De Mexico
Mexico City, Distrito Federal 07760
Mexico
Recruiting Armando Ramirez Ramirez, Site 0154

Instituto Nacional De Cancerologia
Tlalpan, Distrito Federal 14080
Mexico
Recruiting Nora Sobrevilla Moreno, Site 0130

Centro Universitario Contra el Cancer UANL
Monterrey, Nuevo LEON 64460
Mexico
Recruiting Yamil-Alonso Lopez Chuken, Site 0131

Local Institution
Amsterdam, 1066 CX
Netherlands
Recruiting Site 0022

Local Institution
Enschede, 7512KZ
Netherlands
Recruiting Site 0055

Local Institution
Groningen, 9713 GZ
Netherlands
Recruiting Site 0024

Local Institution
Leeuwarden, 8934 AD
Netherlands
Recruiting Site 0026

Local Institution
Bergen, 5021
Norway
Terminated
Local Institution
Lorenskog, 1478
Norway
Recruiting Site 0081

Instituto Nacional De Enfermedades Neoplasicas
Lima, 34
Peru
Recruiting Silvia Neciosup, Site 0030

Clinica El Golf
Lima, Lima 27
Peru
Recruiting Ruth Huaringa Leiva, Site 0031

Ambulatorium Chemioterapii
Bydgoszcz, 85-796
Poland
Recruiting Bogdan Zurawski, Site 0189
+48523743029
Oddzial Dzienny Chemioterapii
Koszalin, 75-581
Poland
Recruiting Mariusz Kwiatkowski, Site 0205
+48943488930 -00-000-00-00
Klinika Nowotworow Ukladu Moczowego Centrum Onkologii - Inst
Warszawa, 02-781
Poland
Recruiting Pawel Wiechno, Site 0202
+48501326278
Local Institution
Cluj-Napoca, 400015
Romania
Recruiting Site 0191

Local Institution
Craiova, 200347
Romania
Recruiting Site 0187

Local Institution
Moscow, 115478
Russian Federation
Not yet recruiting Site 0122

Local Institution
Moscow, 117997
Russian Federation
Recruiting Site 0123

Local Institution
Moscow, 125367
Russian Federation
Recruiting Site 0211

Local Institution
Novosibirsk, 630099
Russian Federation
Not yet recruiting Site 0206

Local Institution
St Petersburg, 198255
Russian Federation
Not yet recruiting Site 0121

Local Institution
Singapore, 169610
Singapore
Recruiting Site 0192

Comp. Hosp. Univ. A Coruna
A Coruna, 15006
Spain
Recruiting Aurea Molina Diaz, Site 0070
+34981178000
Hospital Santa Creu I Sant Pau
Barcelona, 08025
Spain
Recruiting Jose Pablo Maroto Rey, Site 0068
+34935531381 000 000 000
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Spain
Recruiting Teresa Alonso Gordoa, Site 0065
+34913368263
Hosp Univer 12 De Octubre
Madrid, 28041
Spain
Recruiting Daniel Castellano, Site 0066
+34913908339
H. U. Marques de Valdecilla
Santander, 39008
Spain
Recruiting Ignacio Duran, Site 0209
+34942202525
Hosp. Univ. Virgen Del Rocio
Sevilla, 41013
Spain
Recruiting Begona Perez Valderrama, Site 0067
+34955011368
Instituto Valenciano De Oncologia
Valencia, 46009
Spain
Recruiting Miguel Climent, Site 0069
+34961104606
Local Institution
Jonkoping, 551 85
Sweden
Recruiting Site 0075

Local Institution
Linkoping, 581 85
Sweden
Recruiting Site 0059

Local Institution
Lund, 221 85
Sweden
Terminated
Kantonsspital Baden
Baden, 5404
Switzerland
Recruiting Andreas Erdmann, Site 0061
+41564862765
Kantonsspital Graubuenden
Chur, 7000
Switzerland
Recruiting Richard Cathomas, Site 0042
+41812566860
Local Institution
Kaohsiung, 883
Taiwan
Completed
Local Institution
Taichung, 40705
Taiwan
Completed
Local Institution
Taipei, 100
Taiwan
Active, not recruiting
Local Institution
Taipei, 11217
Taiwan
Active, not recruiting
Local Institution
Taoyuan, 333
Taiwan
Active, not recruiting
Local Institution
Ankara, 06590
Turkey
Recruiting Site 0194

Local Institution
Istanbul, 34300
Turkey
Recruiting Site 0204

Local Institution
Izmir, 35340
Turkey
Recruiting Site 0193