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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, 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

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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

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: 855-907-3286

Email: Clinical.Trials@bms.com

LOCATION

Facility Status Contact
Facility: Boca Raton Regional Hospital
Boca Raton, Florida 33486
United States
Status: Recruiting Contact: Contact
Guru Sonpavde, Site 0056
866-408-3324
Facility: Holy Cross Hospital
Fort Lauderdale, Florida 33308
United States
Status: Recruiting Contact: Contact
Guru Sonpavde, Site 0208
866-408-3324
Facility: Cancer Specialists of North FL
Jacksonville, Florida 32256
United States
Status: Recruiting Contact: Contact
Guru Sonpavde, Site 0207
617-632-7334
Facility: University Cancer Blood Ctr
Athens, Georgia 30607
United States
Status: Recruiting Contact: Contact
Tareq Al Baghdadi, Site 0063
734-712-1000
Facility: Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
Thomasville, Georgia 31792
United States
Status: Recruiting Contact: Contact
Gautam Jha, Site 0002
952-460-4074
Facility: University Of Illinois At Chicago
Chicago, Illinois 60612
United States
Status: Recruiting Contact: Contact
Melissa Reimers, Site 0095
314-956-5823
Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Matthew Galsky, Site 0072
212-824-8583
Facility: Milford Regional Medical Center
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Brendan Curti, Site 0104
503-215-5696
Facility: South Shore Hospital Cancer Center
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Jacob Smeltzer, Site 0032
816-932-3295
Facility: St. Joseph Mercy Hospital
Ypsilanti, Michigan 48197
United States
Status: Recruiting Contact: Contact
Shifeng Mao, Site 0013
412-359-8208
Facility: Ridges Cancer Clinic
Burnsville, Minnesota 55337
United States
Status: Recruiting Contact: Contact
Eric Dean, Site 0086
425-899-3977
Facility: Washington University School OF Medicine-Siteman Cancer Center
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Contact
Site 0007

Facility: Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Status: Recruiting Contact: Contact
Site 0006

Facility: NYU Winthrop Hospital Dept of Oncology/Hematology
Mineola, New York 11501
United States
Status: Recruiting Contact: Contact
Site 0096

Facility: Icahn School Of Medicine At Mount Sinai
New York, New York 10029
United States
Status: Recruiting Contact: Contact
Site 0099

Facility: The Ohio State University
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Contact
Site 0101

Facility: Providence Portland Med Ctr
Portland, Oregon 97213
United States
Status: Recruiting Contact: Contact
Site 0100

Facility: St Lukes Hospital
Easton, Pennsylvania 18045
United States
Status: Recruiting Contact: Contact
Site 0017

Facility: Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
Status: Recruiting Contact: Contact
Site 0021

Facility: Seattle Cancer Care Alliance
Kirkland, Washington 98034
United States
Status: Recruiting Contact: Contact
Site 0016

Facility: Local Institution - 0005
Capital Federal, Buenos Aires 1426
Argentina
Status: Recruiting Contact: Contact
Site 0019

Facility: Local Institution - 0007
Mar Del Plata, Buenos Aires 7600
Argentina
Status: Recruiting Contact: Contact
Site 0053

Facility: Local Institution - 0008
Viedma, RIO Negro 8500
Argentina
Status: Recruiting Contact: Contact
Site 0052

Facility: Local Institution - 0009
Buenos Aires, New South Wales 1120
Argentina
Status: Recruiting Contact: Contact
Site 0010

Facility: Local Institution - 0134
Cordoba, New South Wales 5000
Argentina
Status: Recruiting Contact: Contact
Site 0012

Facility: Local Institution - 0006
Cordoba, New South Wales 5004
Argentina
Status: Recruiting Contact: Contact
Site 0106

Facility: Local Institution - 0096
Waratah, Queensland 2298
Australia
Status: Recruiting Contact: Contact
Site 0169

Facility: Local Institution - 0099
Westmead, Victoria 2145
Australia
Status: Recruiting Contact: Contact
Site 0182

Facility: Local Institution - 0188
South Brisbane, Western Australia 4101
Australia
Status: Recruiting Contact: Contact
Site 0219

Facility: Local Institution - 0120
Tugun, Distrito Federal 4224
Australia
Status: Recruiting Contact: Contact
Site 0180

Facility: Local Institution - 0101
Heidelberg, RIO Grande DO SUL 3084
Australia
Status: Recruiting Contact: Contact
Site 0177

Facility: Local Institution
Doubleview, RIO Grande DO SUL 6018
Australia
Status: Recruiting Contact: Contact
Site 0176

Facility: Local Institution - 0017
Brasilia, RIO Grande DO SUL 70200-730
Brazil
Status: Recruiting Contact: Contact
Site 0175

Facility: Local Institution - 0021
Ijui, Santa Catarina 98700-000
Brazil
Status: Recruiting Contact: Contact
Site 0186

Facility: Local Institution - 0119
Passo Fundo, Sao Paulo 99010-080
Brazil
Status: Recruiting Contact: Contact
Site 0220

Facility: Local Institution - 0020
Porto Alegre, Sao Paulo 90610000
Brazil
Status: Recruiting Contact: Contact
Site 0216

Facility: Local Institution - 0016
Florianopolis, Nova Scotia 88034-000
Brazil
Status: Recruiting Contact: Contact
Site 0167

Facility: Local Institution - 0018
Barretos, Ontario 14784-400
Brazil
Status: Recruiting Contact: Contact
Site 0162

Facility: Local Institution - 0019
Sao Jose Do Rio Preto, Quebec 15090-000
Brazil
Status: Recruiting Contact: Contact
Site 0163

Facility: Local Institution - 0053
Halifax, Metropolitana B3H 2Y9
Canada
Status: Recruiting Contact: Contact
Site 0174

Facility: Local Institution - 0052
Sherbrooke, Beijing J1H 5N4
Canada
Status: Recruiting Contact: Contact
Site 0173

Facility: Local Institution - 0010
Santiago, Chongqing 8420383
Chile
Status: Recruiting Contact: Contact
Site 0164

Facility: Local Institution - 0012
Vina del Mar, Heilongjiang 0
Chile
Status: Recruiting Contact: Contact
Site 0152

Facility: Local Institution - 0106
Vitacura, Hubei 100001
Chile
Status: Recruiting Contact: Contact
Site 0190

Facility: Local Institution - 0171
Beijing, Jiangsu 100034
China
Status: Recruiting Contact: Contact
Site 0196

Facility: Local Institution - 0169
Beijing, Jiangsu 400030
China
Status: Recruiting Contact: Contact
Site 0089

Facility: Local Institution - 0182
Chongqing, Jiangsu 550002
China
Status: Recruiting Contact: Contact
Site 0088

Facility: Local Institution - 0219
Harbin, Shan1xi 430030
China
Status: Recruiting Contact: Contact
Site 0090

Facility: Local Institution - 0180
Wuhan, Shandong 210000
China
Status: Recruiting Contact: Contact
Site 0092

Facility: Local Institution - 0177
Nanjing, Shanghai 210008
China
Status: Recruiting Contact: Contact
Site 0093

Facility: Local Institution - 0176
Nanjing, Shanghai 0
China
Status: Recruiting Contact: Contact
Site 0094

Facility: Local Institution - 0175
Nanjng, Shanghai 130021
China
Status: Recruiting Contact: Contact
Site 0048

Facility: Local Institution - 0186
Changchun, Shanghai 030001
China
Status: Recruiting Contact: Contact
Site 0047

Facility: Local Institution - 0220
Taiyuan, Sichuan 264000
China
Status: Recruiting Contact: Contact
Site 0049

Facility: Local Institution - 0216
Yantai, Zhejiang 200025
China
Status: Recruiting Contact: Contact
Site 0037

Facility: Local Institution - 0167
Shanghai, Zhejiang 200032
China
Status: Recruiting Contact: Contact
Site 0041

Facility: Local Institution - 0162
Shanghai, Zhejiang 200040
China
Status: Recruiting Contact: Contact
Site 0213

Facility: Local Institution - 0163
Shanghai, Aomori 200433
China
Status: Recruiting Contact: Contact
Site 0038

Facility: Local Institution - 0184
Chengdu, Ehime 310009
China
Status: Recruiting Contact: Contact
Site 0114

Facility: Local Institution - 0174
Hangzhou, Fukuoka 310014
China
Status: Recruiting Contact: Contact
Site 0039

Facility: Local Institution - 0172
Hangzhou, Hokkaido 310022
China
Status: Recruiting Contact: Contact
Site 0102

Facility: Local Institution - 0173
Hangzhou, Ibaraki 100083
China
Status: Recruiting Contact: Contact
Site 0103

Facility: Local Institution - 0170
Beijing, Iwate 200032
China
Status: Recruiting Contact: Contact
Site 0199

Facility: Local Institution - 0164
Shanghai, Kagawa 656 53
China
Status: Recruiting Contact: Contact
Site 0198

Facility: Local Institution - 0160
Brno, Niigata 500 05
Czechia
Status: Recruiting Contact: Contact
Site 0108

Facility: Local Institution - 0152
Hradec Kralove, Okayama 9210
Czechia
Status: Recruiting Contact: Contact
Site 0197

Facility: Local Institution - 0190
Aalborg, Osaka 2730
Denmark
Status: Recruiting Contact: Contact
Site 0111

Facility: Local Institution - 0196
Herlev, Osaka 00029
Denmark
Status: Recruiting Contact: Contact
Site 0109

Facility: Local Institution - 0089
Lille, Shizuoka 13273
France
Status: Recruiting Contact: Contact
Site 0110

Facility: Local Institution - 0088
Marseille Cedex 9, Tokyo 30029
France
Status: Recruiting Contact: Contact
Site 0129

Facility: Local Institution - 0091
Nimes Cedex 09, Tokyo 42271
France
Status: Recruiting Contact: Contact
Site 0130

Facility: Local Institution - 0090
Saint Priest En Jarez, Tokyo 92151
France
Status: Recruiting Contact: Contact
Site 0022

Facility: Local Institution - 0092
Suresnes, Tokyo 37044
France
Status: Recruiting Contact: Contact
Site 0055

Facility: Local Institution - 0093
Tours Cedex, Wakayama 94805
France
Status: Recruiting Contact: Contact
Site 0024

Facility: Local Institution - 0094
Villejuif, Yamaguchi 01307
France
Status: Recruiting Contact: Contact
Site 0026

Facility: Local Institution - 0048
Essen, Distrito Federal 79106
Germany
Status: Recruiting Contact: Contact
Site 0030

Facility: Local Institution - 0047
Freiburg, Distrito Federal 22763
Germany
Status: Recruiting Contact: Contact
Site 0031

Facility: Local Institution - 0049
Hamburg, Nuevo Leon 30625
Germany
Status: Recruiting Contact: Contact
Site 0191

Facility: Local Institution - 0037
Hannover, Cluj 07747
Germany
Status: Recruiting Contact: Contact
Site 0187

Facility: Local Institution - 0041
Jena, 68167
Germany
Status: Recruiting Contact: Contact
Site 0121

Facility: Local Institution - 0213
Mannheim, 81675
Germany
Status: Recruiting Contact: Contact
Site 0192

Facility: Local Institution - 0038
Nuernberg, 72076
Germany
Status: Recruiting Contact: Contact
Site 0068

Facility: Local Institution - 0040
Tuebingen, 92637
Germany
Status: Recruiting Contact: Contact
Site 0065

Facility: Local Institution - 0114
Weiden, 97080
Germany
Status: Recruiting Contact: Contact
Site 0066

Facility: Local Institution - 0039
Wuerzburg, 11528
Germany
Status: Recruiting Contact: Contact
Site 0209

Facility: Local Institution - 0102
Athens, 45500
Greece
Status: Recruiting Contact: Contact
Site 0067

Facility: Local Institution - 0103
Ioannina, 1082
Greece
Status: Recruiting Contact: Contact
Site 0069

Facility: Local Institution - 0199
Kfar Saba, 52100
Israel
Status: Recruiting Contact: N/A
Facility: Local Institution - 0198
Ramat Gan, 48018
Israel
Status: Recruiting Contact: N/A
Facility: Local Institution - 0108
Arezzo, 47014
Italy
Status: Recruiting Contact: N/A
Facility: Local Institution - 0197
Faenza, 58100
Italy
Status: Recruiting Contact: N/A
Facility: Local Institution - 0111
Forlì, 20133
Italy
Status: Recruiting Contact: N/A
Facility: Local Institution - 0109
Grosseto, 80131
Italy
Status: Recruiting Contact: N/A
Facility: Local Institution - 0107
Milano, 036-8563
Italy
Status: Recruiting Contact: N/A
Facility: Local Institution - 0110
Napoli, 260-8717
Italy
Status: Recruiting Contact: N/A
Facility: Local Institution - 0129
Ciudad de Mexico, 14080
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution - 0130
Tlalpan, 1066 CX
Mexico
Status: Recruiting Contact: N/A
Facility: Local Institution - 0022
Amsterdam, 9713 GZ
Netherlands
Status: Recruiting Contact: N/A
Facility: Local Institution - 0024
Groningen, 5021
Netherlands
Status: Recruiting Contact: N/A
Facility: Local Institution - 0026
Leeuwarden, 1478
Netherlands
Status: Recruiting Contact: N/A
Facility: Local Institution - 0081
Lorenskog, Lima 27
Norway
Status: Recruiting Contact: N/A
Facility: Local Institution - 0030
Lima, 85-796
Peru
Status: Recruiting Contact: N/A
Facility: Local Institution - 0031
Lima, 75-581
Peru
Status: Recruiting Contact: N/A
Facility: Local Institution - 0191
Cluj-Napoca, 115478
Romania
Status: Recruiting Contact: N/A
Facility: Local Institution - 0187
Craiova, 117997
Romania
Status: Recruiting Contact: N/A
Facility: Local Institution - 0192
Singapore, 08025
Singapore
Status: Recruiting Contact: N/A
Facility: Local Institution - 0070
A Coruna, 28034
Spain
Status: Recruiting Contact: N/A
Facility: Local Institution - 0068
Barcelona, 28041
Spain
Status: Recruiting Contact: N/A
Facility: Local Institution - 0065
Madrid, 39008
Spain
Status: Recruiting Contact: N/A
Facility: Local Institution - 0066
Madrid, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Local Institution - 0209
Santander, 46009
Spain
Status: Recruiting Contact: N/A
Facility: Local Institution - 0067
Sevilla, 553 05
Spain
Status: Recruiting Contact: N/A
Facility: Local Institution - 0069
Valencia, 581 85
Spain
Status: Recruiting Contact: N/A
Facility: Local Institution - 0075
Jonkoping, 221 85
Sweden
Status: Recruiting Contact: N/A
Facility: Local Institution - 0061
Baden, 833
Switzerland
Status: Recruiting Contact: N/A
Facility: Local Institution - 0042
Chur, 40705
Switzerland
Status: Recruiting Contact: N/A
Facility: Local Institution - 0194
Ankara, 35340
Turkey
Status: Recruiting Contact: N/A
Facility: Local Institution - 0204
Istanbul,
Turkey
Status: Recruiting Contact: N/A