Back to Clinical Trials

Brief Title: Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable 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

INTRODUCTION

  • Org Study ID: CA209-901
  • Secondary ID: 2016-003881-14
  • NTC ID: NCT03036098
  • Sponsor: Bristol-Myers Squibb
BMS Clinical Trial Information, BMS Clinical Trial Patient Recruiting, Investigator Inquiry Form, FDA Safety Alerts and Recalls

DESCRIPTION

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

Who is this trial for?

Patients who have urothelial cancer (UC -cancer of the bladder, ureter, urethra or renal pelvis) that has spread or cannot  be removed by surgery

What is the goal of this study?

To purpose of this study is to assess the effects of addition of immunotherapy to chemotherapy in patients with  untreated inoperable UC or UC that has spread to different parts of the body (metastatic).

Background

Patients with advanced UC have poor outcomes, with 5-year survival rates of <5% for those with metastatic, stage IV disease. Median overall survival with standard of care chemotherapy is ~13 months.  Therefore, there is a need for studying novel treatment approaches that might improve patient outcomes.   This clinical trial is exploring the addition of immunotherapy to standard of care chemotherapy. Clinical trials are conducted to learn whether a new drug, treatment, or combination works and is safe to use for people. You can volunteer to take part in a clinical trial if you are eligible.

You may be eligible for this clinical study if you:

– Have bladder cancer that has spread or cannot be removed with surgery

– Have not been treated since your cancer has spread

– Are eligible for cisplatin treatment

Participation in this clinical trial is determined using the full eligibility criteria. Some key eligibility criteria are above. To pre-screen for this study or other bladder cancer studies, please take the Bladder Cancer Screener on BMS Study Connect.

Gender: All              Minimum Age: 18 Years          Maximum Age: N/A

Study Design

If enrolled in the study you will be assigned to one of the following study treatment arms and receive the outlined study treatment

Arm  C: Nivolumab + chemotherapy

Arm  D: chemotherapy

Considering a clinical trial?

There is a lot to think about when considering a clinical trial.

Download this pdf to discuss 2 clinical trial options with your doctor.

Visit BMSSTUDYCONNECT.com/ to learn move and to take a screener to see if you qualify

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 participants with previously untreated inoperable or metastatic urothelial cancer.

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

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: Up to 55 months

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

Primary Outcome 2 - Timeframe: Up to 52 months

Primary Outcome 3 - Measure: Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC

Primary Outcome 3 - Timeframe: Up to 64 months

Primary Outcome 4 - Measure: Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC

Primary Outcome 4 - Timeframe: Up to 64 months

CONDITION

  • Urothelial Cancer

ELIGIBILITY

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra

- No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

- Women and men must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
Disease that is suitable for local therapy administered with curative intent

- Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results

- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol-defined inclusion/exclusion criteria apply

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: Bristol-Myers Squibb

Phone: please email:

Email: Clinical.Trials@bms.com

LOCATION

Facility Status Contact
Facility: VA of Central California Health Care System
Fresno, California 93703
United States
Status: Recruiting Contact: Contact
PETROS NIKOLINAKOS, Site 0004
706-353-2990
Facility: Boca Raton Regional Hospital
Boca Raton, Florida 33486
United States
Status: Recruiting Contact: Contact
Michael Abern, Site 0046
312-996-1588
Facility: Holy Cross Hospital
Fort Lauderdale, Florida 33308
United States
Status: Recruiting Contact: Contact
Guru Sonpavde, Site 0073
617-632-7334
Facility: Cancer Specialists of North FL
Jacksonville, Florida 32256
United States
Status: Recruiting Contact: Contact
Guru Sonpavde, Site 0056
617-582-7334
Facility: University Cancer Blood Ctr
Athens, Georgia 30607
United States
Status: Recruiting Contact: Contact
Guru Sonpavde, Site 0208
617-632-7334
Facility: Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
Thomasville, Georgia 31792
United States
Status: Recruiting Contact: Contact
Guru Sonpavde, Site 0207
617-632-7334
Facility: University Of Illinois At Chicago
Chicago, Illinois 60612
United States
Status: Recruiting Contact: Contact
Tareq Al Baghdadi, Site 0063
734-712-5674
Facility: Dana Farber Cancer Institute-Parent Account
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Gurkamal Chatta, Site 0083
716-845-1439
Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Mary O'Keeffe, Site 0014
516-663-3115
Facility: Milford Regional Medical Center
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Matthew Galsky, Site 0072
212-824-7117
Facility: South Shore Hospital Cancer Center
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Amir Mortazavi, Site 0082
614-292-4963
Facility: St. Joseph Mercy Hospital
Ypsilanti, Michigan 48197
United States
Status: Recruiting Contact: Contact
Brendan Curti, Site 0104
503-215-2604
Facility: Ridges Cancer Clinic
Burnsville, Minnesota 55337
United States
Status: Recruiting Contact: Contact
Jacob Smeltzer, Site 0032
816-932-2677
Facility: Washington University School OF Medicine-Siteman Cancer Center
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Contact
Eric Dean, Site 0086
425-899-3977
Facility: Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Status: Recruiting Contact: Contact
Juan Ignacio Hernandez Moran, Site 0009
+541149642424
Facility: NYU Winthrop Hospital Dept of Oncology/Hematology
Mineola, New York 11501
United States
Status: Recruiting Contact: Contact
Martin Richardet, Site 0134
+543514601544
Facility: Icahn School Of Medicine At Mount Sinai
New York, New York 10029
United States
Status: Recruiting Contact: Contact
Santiago Bella, Site 0006
+543514142121
Facility: The Ohio State University
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Contact
Site 0188
+555421034130
Facility: Providence Portland Med Ctr
Portland, Oregon 97213
United States
Status: Recruiting Contact: Contact
Site 0120
+555181181602
Facility: St Lukes Hospital
Easton, Pennsylvania 18045
United States
Status: Recruiting Contact: Contact
Site 0101
+554833311553
Facility: Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
Status: Recruiting Contact: Contact
Site 0100
+551733216638
Facility: Seattle Cancer Care Alliance
Kirkland, Washington 98034
United States
Status: Recruiting Contact: Contact
Nicolas Lazaretti, Site 0119
819346111012811
Facility: Instituto Medico Especializado Alexander Fleming
Capital Federal, Buenos Aires 1426
Argentina
Status: Recruiting Contact: Contact
Marcelo Freitas, Site 0016
+56322323781
Facility: Hospital Privado De Comunidad
Mar Del Plata, Buenos Aires 7600
Argentina
Status: Recruiting Contact: Contact
Joao Antonio Junior, Site 0018
+420543132216
Facility: Clinica Viedma S.A.
Viedma, RIO Negro 8500
Argentina
Status: Recruiting Contact: Contact
Gustavo Girotto, Site 0019
+420495832176
Facility: Centro De Diagnostico Urologico S.R.L.
Buenos Aires, New South Wales 1120
Argentina
Status: Recruiting Contact: Contact
Robyn Macfarlane, Site 0053
+492017232000
Facility: Instituto Oncologico De Cordoba
Cordoba, New South Wales 5000
Argentina
Status: Recruiting Contact: Contact
Michel Pavic, Site 0052
+4976127073610
Facility: Clinica Universitaria Reina Fabiola
Cordoba, New South Wales 5004
Argentina
Status: Recruiting Contact: Contact
Mauricio Burotto, Site 0010
+49401818818635
Facility: Local Institution
Waratah, Queensland 2298
Australia
Status: Recruiting Contact: Contact
Site 0106
+4936419329956
Facility: Local Institution
Westmead, Victoria 2145
Australia
Status: Recruiting Contact: Contact
Site 0171
+496213834973
Facility: Local Institution
South Brisbane, Western Australia 4101
Australia
Status: Recruiting Contact: Contact
Site 0169
+499113983085
Facility: Local Institution
Tugun, Distrito Federal 4224
Australia
Status: Recruiting Contact: Contact
Site 0182
+4970712987235
Facility: Local Institution
Heidelberg, RIO Grande DO SUL 3084
Australia
Status: Recruiting Contact: Contact
Site 0217
+499613033307
Facility: Local Institution
Nedlands, RIO Grande DO SUL 6009
Australia
Status: Recruiting Contact: Contact
Site 0219
+4993120132001
Facility: Hospital Sirio Libanes
Brasilia, RIO Grande DO SUL 70200-730
Brazil
Status: Recruiting Contact: Contact
Site 0180
+302132162845
Facility: Associacao Hospital de Caridade Ijui
Ijui, Santa Catarina 98700-000
Brazil
Status: Recruiting Contact: Contact
Site 0177
+302651099394
Facility: Hospital Sao Vicente De Paulo
Passo Fundo, Sao Paulo 99010-080
Brazil
Status: Recruiting Contact: Contact
Site 0176
+3905752551
Facility: Hospital Sao Lucas Da Pucrs
Porto Alegre, Sao Paulo 90610-000
Brazil
Status: Recruiting Contact: Contact
Site 0175
+390546601111
Facility: Centro de Pesquisas Oncologicas de Santa Catarina-CEPON
Florianopolis, Nova Scotia 88034-000
Brazil
Status: Recruiting Contact: Contact
Site 0186
+390543739100
Facility: Fundacao Pio Xii Hosp Cancer De Barretos
Barretos, Ontario 14784-400
Brazil
Status: Recruiting Contact: Contact
Site 0220
+390564485034
Facility: Hospital De Base Da Faculdade De Medicina De Rio Preto
Sao Jose Do Rio Preto, Quebec 15090-000
Brazil
Status: Recruiting Contact: Contact
Site 0216
+390223901
Facility: Nova Scotia Health Authority QEII Health Sciences Centre
Halifax, Metropolitana B3H 2Y9
Canada
Status: Recruiting Contact: Contact
Site 0162
+5112016500x3009
Facility: Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
Sherbrooke, Beijing J1H 5N4
Canada
Status: Recruiting Contact: Contact
Site 0184
+34981178000ext
Facility: Centro Internacional de Estudios Clinicos
Recoleta, Chongqing 8420383
Chile
Status: Recruiting Contact: Contact
Site 0172
+34913368263
Facility: Oncocentro Apys
Vina del Mar, Heilongjiang 100001
Chile
Status: Recruiting Contact: Contact
Site 0170
+34942202525
Facility: Local Institution
Vitacura, Hubei 100034
Chile
Status: Recruiting Contact: Contact
Site 0164
+34955011368
Facility: Local Institution
Beijing, Jiangsu 400030
China
Status: Recruiting Contact: Contact
Alexandr Poprach, Site 0160
+34961104606
Facility: Local Institution
Beijing, Jiangsu 550002
China
Status: Recruiting Contact: Contact
Jindrich Kopecky, Site 0152
+41564862765
Facility: Local Institution
Chongqing, Jiangsu 150040
China
Status: Recruiting Contact: Contact
Site 0190
+41812566860
Facility: Local Institution
Wuhan, Shandong 210008
China
Status: Recruiting Contact: Contact
Site 0088

Facility: Local Institution
Nanjing, Shanghai 130021
China
Status: Recruiting Contact: Contact
Site 0091

Facility: Local Institution
Nanjing, Shanghai 030001
China
Status: Recruiting Contact: Contact
Site 0090

Facility: Local Institution
Nanjng, Shanghai 264000
China
Status: Recruiting Contact: Contact
Site 0092

Facility: Local Institution
Changchun, Shanghai 200025
China
Status: Recruiting Contact: Contact
Site 0093

Facility: Local Institution
Shanghai, Zhejiang 200433
China
Status: Recruiting Contact: Contact
Cornelius Waller, Site 0047

Facility: Local Institution
Shanghai, Zhejiang 610041
China
Status: Recruiting Contact: Contact
Christian Wuelfing, Site 0049

Facility: Local Institution
Shanghai, Aomori 310009
China
Status: Recruiting Contact: Contact
Christoph von Klot, Site 0037

Facility: Local Institution
Chengdu, Ehime 310022
China
Status: Recruiting Contact: Contact
Philipp Nuhn, Site 0213

Facility: Local Institution
Hangzhou, Fukuoka 100083
China
Status: Recruiting Contact: Contact
Marinela Augustin, Site 0038

Facility: Local Institution
Hangzhou, Hokkaido 200032
China
Status: Recruiting Contact: Contact
Jens Bedke, Site 0040

Facility: Local Institution
Hangzhou, Ibaraki 656 53
China
Status: Recruiting Contact: Contact
Thomas Bschleipfer, Site 0114

Facility: Local Institution
Beijing, Iwate 500 05
China
Status: Recruiting Contact: Contact
Hubert Kuebler, Site 0039

Facility: Local Institution
Shanghai, Kagawa 9100
China
Status: Recruiting Contact: Contact
Aristotelis Bamias, Site 0102

Facility: Klinika komplexni onkologicke pece
Brno, Niigata 2730
Czechia
Status: Recruiting Contact: Contact
Davide Mauri, Site 0103

Facility: Klinika onkologie a radioterapie
Hradec Kralove, Okayama 00029
Czechia
Status: Recruiting Contact: Contact
Site 0034

Facility: Local Institution
Aalborg, Osaka 59000
Denmark
Status: Recruiting Contact: Contact
Site 0029

Facility: Local Institution
Herlev, Osaka 13273
Denmark
Status: Recruiting Contact: Contact
Site 0043

Facility: Local Institution
Lille, Shizuoka 42271
France
Status: Recruiting Contact: Contact
Site 0035

Facility: Local Institution
Marseille Cedex 9, Tokyo 92151
France
Status: Recruiting Contact: Contact
Site 0199

Facility: Local Institution
Nimes Cedex 09, Tokyo 37044
France
Status: Recruiting Contact: Contact
Site 0198

Facility: Local Institution
Saint Priest En Jarez, Tokyo 94805
France
Status: Recruiting Contact: Contact
Alketa Hamzaj, Site 0108

Facility: Local Institution
Suresnes, Tokyo 01307
France
Status: Recruiting Contact: Contact
Francesco Carrozza, Site 0197

Facility: Local Institution
Tours Cedex, Wakayama 45147
France
Status: Recruiting Contact: Contact
Ugo De Giorgi, Site 0111

Facility: Local Institution
Villejuif, Yamaguchi 79106
France
Status: Recruiting Contact: Contact
Carmelo Bengala, Site 0109

Facility: Universitaetsklinikum Essen
Essen, Distrito Federal 30625
Germany
Status: Recruiting Contact: Contact
Ferdinando Riccardi, Site 0110

Facility: Medizinische Universitaetsklinik Freiburg
Freiburg, Distrito Federal 07747
Germany
Status: Recruiting Contact: Contact
Site 0129

Facility: Asklepios Klinik Altona
Hamburg, Nuevo Leon 68167
Germany
Status: Recruiting Contact: Contact
Site 0130

Facility: Medizinische Hochschule Hannover
Hannover, 81675
Germany
Status: Recruiting Contact: Contact
Site 0022

Facility: Universitaetsklinikum Jena
Jena, 90419
Germany
Status: Recruiting Contact: Contact
Site 0055

Facility: Universitaetsklinikum Mannheim
Mannheim, 72076
Germany
Status: Recruiting Contact: Contact
Site 0024

Facility: Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg, 97080
Germany
Status: Recruiting Contact: Contact
Site 0081

Facility: Uniklinik Tuebingen
Tuebingen, 11528
Germany
Status: Recruiting Contact: Contact
Silvia Neciosup, Site 0030

Facility: Kliniken Nordoberpfalz AG
Weiden, 45500
Germany
Status: Recruiting Contact: Contact
Ruth Huaringa Leiva, Site 0031

Facility: Univ. Klinikum Wuerzburg
Wuerzburg, 1082
Germany
Status: Recruiting Contact: Contact
Site 0191

Facility: Alexandra General Hospital
Athens, 1122
Greece
Status: Recruiting Contact: Contact
Site 0187

Facility: Ioannina University Hospital
Ioannina, 1145
Greece
Status: Recruiting Contact: Contact
Site 0211

Facility: Local Institution
Kfar Saba, 47014
Israel
Status: Recruiting Contact: Contact
Daniel Castellano Gauna, Site 0066

Facility: Local Institution
Ramat Gan, 58100
Israel
Status: Recruiting Contact: Contact
Ignacio Duran Martinez, Site 0209

Facility: Ospedale S. Donato - Usl 8
Arezzo, 20133
Italy
Status: Recruiting Contact: Contact
Begona Perez Valderrama, Site 0067

Facility: Ospedale Per Gli Infermi
Faenza, 80131
Italy
Status: Recruiting Contact: Contact
Miguel Climent Duran, Site 0069

Facility: IRST Meldola
Forlì, 036-8563
Italy
Status: Recruiting Contact: Contact
Site 0075

Facility: Ospedale Della Misericordia Grosseto
Grosseto, 260-8717
Italy
Status: Recruiting Contact: Contact
Andreas Erdmann, Site 0061

Facility: IRCCS Istituto Nazionale Tumori Milano
Milano, 7910280
Italy
Status: Recruiting Contact: Contact
Richard Cathomas, Site 0042

Facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
Napoli, 8128582
Italy
Status: Recruiting Contact: Contact
Site 0194

Facility: Local Institution
Ciudad de Mexico, 1066 CX
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution
Tlalpan, 9713 GZ
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution
Amsterdam, 5021
Netherlands
Status: Recruiting Contact: N/A
Facility: Local Institution
Groningen, 34
Netherlands
Status: Recruiting Contact: N/A
Facility: Local Institution
Leeuwarden, Lima 27
Netherlands
Status: Recruiting Contact: N/A
Facility: Local Institution
Lorenskog, 75-581
Norway
Status: Recruiting Contact: N/A
Facility: Instituto Nacional De Enfermedades Neoplasicas
Lima, 02-781
Peru
Status: Recruiting Contact: N/A
Facility: Clinica El Golf
Lima, 400015
Peru
Status: Recruiting Contact: N/A
Facility: Local Institution
Cluj-Napoca, 125367
Romania
Status: Recruiting Contact: N/A
Facility: Local Institution
Craiova, 630099
Romania
Status: Recruiting Contact: N/A
Facility: Local Institution
Moscow, 15006
Russian Federation
Status: Recruiting Contact: N/A
Facility: Local Institution
Singapore, 28041
Singapore
Status: Recruiting Contact: N/A
Facility: Comp. Hosp. Univ. A Coruna
A Coruna, 39008
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Santa Creu I Sant Pau
Barcelona, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Ramon Y Cajal
Madrid, 46009
Spain
Status: Recruiting Contact: N/A
Facility: Hosp Univer 12 De Octubre
Madrid, 551 85
Spain
Status: Recruiting Contact: N/A
Facility: H. U. Marques de Valdecilla
Santander, 581 85
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Virgen Del Rocio
Sevilla, 221 85
Spain
Status: Recruiting Contact: N/A
Facility: Instituto Valenciano De Oncologia
Valencia, 5404
Spain
Status: Recruiting Contact: N/A
Facility: Local Institution
Jonkoping, 7000
Sweden
Status: Recruiting Contact: N/A
Facility: Kantonsspital Baden
Baden, 100
Switzerland
Status: Recruiting Contact: N/A
Facility: Kantonsspital Graubuenden
Chur, 11217
Switzerland
Status: Recruiting Contact: N/A
Facility: Local Institution
Ankara,
Turkey
Status: Recruiting Contact: N/A
Facility: Local Institution
Istanbul,
Turkey
Status: Recruiting Contact: N/A
Facility: Local Institution
Izmir,
Turkey
Status: Recruiting Contact: N/A