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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:March 24, 2017
End Date:December 23, 2022
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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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

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.


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
We found this trial at
38
sites
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Phone: 954-267-7750
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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Fort Lauderdale, FL
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Phone: 503-215-2604
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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Albuquerque, New Mexico 87131
(505) 277-0111
Phone: 505-272-7813
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Anchorage, Alaska 99503
Phone: 907-276-1455
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Athens, Georgia 30607
Phone: 706-353-2990
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Birmingham, Alabama 35294
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Boca Raton, Florida 33486
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Boston, Massachusetts 02215
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Boston, Massachusetts 02215
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-582-7334
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Burnsville, Minnesota 55337
Phone: 952-836-3608
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Capital Federal, Buenos Aires
Phone: +541132218900
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Phone: 312-996-1588
University of Illinois at Chicago A major research university in the heart of one of...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-681-9822
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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2615 East Clinton Avenue
Fresno, California 93703
Phone: 559-225-6100
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Hattiesburg, Mississippi 39401
Phone: 601-288-2495
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200 Technology Drive
Hooksett, New Hampshire 03106
Phone: 603-622-6484
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Houston, Texas 77030
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Iowa City, Iowa 52242
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Jacksonville, Florida 32256
Phone: 904-363-7462
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Kansas City, Missouri 64111
Phone: 816-932-2677
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Kirkland, Washington 98034
Phone: 425-899-3977
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Little Rock, Arkansas 72201
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Milwaukee, Wisconsin 53226
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259 1st St
Mineola, New York 11501
(516) 663-0333
Phone: 516-663-3115
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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New Orleans, Louisiana 70121
Phone: 504-703-2652
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New York, New York 10016
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Phone: 212-824-7117
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Omaha, Nebraska 68130
Phone: 402-991-8468
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Phone: 412-359-6452
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-747-1343
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84132
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Santa Rosa, California 95403
Phone: 707-521-3830
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Thomasville, Georgia 31792
Phone: 229-584-5417
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Ypsilanti, Michigan 48197
Phone: 734-712-5674
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