An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:February 11, 2016
End Date:November 27, 2026
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

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A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared
to placebo in participants who have undergone radical surgery for invasive urothelial cancer.


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Must have had invasive urothelial cancer at high risk of recurrence originating in the
bladder, ureter, or renal pelvis

- Must have had radical surgical resection (e.g. radical cystectomy), performed within
the last 120 days

- Must have disease free status as determined by imaging within 4 weeks of dosing

- Tumor tissue must be provided for biomarker analysis

- Patients who have not received prior neoadjuvant cisplatin chemotherapy must be
ineligible for or refuse cisplatin-based adjuvant chemotherapy

Exclusion Criteria:

- Partial bladder or partial kidney removal (eg, partial cystectomy or partial
nephrectomy)

- Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following
surgical removal of bladder cancer

- Subjects with active, known or suspected autoimmune disease

- Prior malignancy active within the previous 3 years except for locally curable cancers
that have been apparently cured

- Condition requiring systemic treatment with either corticosteroids or other
immunosuppressive medications within 14 day of study drug administration

- Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus
ribonucleic acid (HCV antibody) indicating acute or chronic infection
We found this trial at
34
sites
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Phone: 212-824-7372
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Phone: 716-845-7754
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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Gainesville, Florida 32610
(352) 392-3261
Phone: 352-273-7832
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Phone: 503-215-3943
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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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-3618
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Albany, New York 12206
Phone: 518-262-6696
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Allentown, Pennsylvania 18105
Phone: 610-402-1642
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Anchorage, Alaska 99503
Phone: 907-276-1455
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Berazategui, Buenos Aires
Phone: +541143509606
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303 East Nicollet Boulevard
Burnsville, Minnesota 55337
Phone: 952-836-3608
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Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-962-8489
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chattanooga, Tennessee 37403
Phone: 423-778-2982
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Durham, North Carolina 27710
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Fort Wayne, Indiana 46845
Phone: 260-484-8830
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Fresno, California
Phone: 559-499-6636
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Grand Rapids, Michigan 49503
Phone: 616-954-9800
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Lakewood, Colorado 80228
Phone: 303-285-5081
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Phone: 708-327-2237
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Miami Beach, Florida 33140
Phone: 305-674-2625
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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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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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New Orleans, Louisiana 70112
Phone: 504-988-6542
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-422-4333
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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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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5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
Phone: 412-623-8962
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Rochester, Minnesota 55905
Phone: 507-284-6420
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
Phone: 916-734-3691
University of California-Davis As we begin our second century, UC Davis is poised to become...
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Phone: 415-600-3613
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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Tampa, Florida 33612
Phone: 813-745-1172
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Tualatin, Oregon 97062
Phone: 503-528-5002
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Tucson, Arizona 85745
Phone: 520-269-3821
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4500 Main Street
Virginia Beach, Virginia 23462
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