A Study Comparing the Combination of Nivolumab and Ipilimumab Versus Placebo in Participants With Localized Renal Cell Carcinoma



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:July 5, 2017
End Date:July 7, 2023
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 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

The purpose of this study is to determine whether the combination of nivolumab and ipilimumab
is safe and effective for delaying or preventing recurrence of cancer in patients who have
experienced the partial or entire removal of a kidney


Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

- Kidney tumor has been completely resected 4 to 12 weeks prior to randomization

- Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G
any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0

- Post-nephrectomy tumor shows RCC with a predominantly clear cell histology, including
participants with sarcomatoid features

Exclusion Criteria:

- Participants with an active known or suspected autoimmune disease

- Known history of positive test for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS)

- Any severe or serious, acute or chronic medical or psychiatric condition, or
laboratory abnormality that may increase the risk associated with study participation

- Participants with a condition requiring systemic treatment with corticosteroids

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
21
sites
303 East Superior Street
Chicago, Illinois 60611
Phone: 312-695-2309
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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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Albany, New York 12206
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Phone: 610-402-1184
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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Athens, Georgia 30607
Phone: 706-353-2990
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Atlanta, Georgia 30342
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Birmingham, Alabama 35223
Phone: 205-263-9746
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Chattanooga, Tennessee 37403
Phone: 423-778-2982
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-685-9955
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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600 Southeast 6th Street
Evansville, Indiana 47713
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Fairfax, Virginia 22031
Phone: 703-970-6488
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Fayetteville, Arkansas 72703
Phone: 479-695-4167
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Greenville, South Carolina 29601
Phone: 864-603-6300
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Mar del Plata, Buenos Aires
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1945 New Jersey 33
Neptune, New Jersey 07753
Phone: 732-776-2421
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New Haven, Connecticut 06520
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-6732
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Portland, Oregon 97213
Phone: 503-215-3943
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Saint Louis, Missouri 63110
Phone: 314-996-3452
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San Francisco, California 94110
Phone: 415-600-5743
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Seattle, Washington 98109
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