Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/18/2018
Start Date:October 13, 2014
End Date:September 30, 2019

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A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

The purpose of this study is to compare the objective response rate, progression free
survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib
monotherapy in patients with previously untreated Renal Cell Cancer.


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

Inclusion Criteria:

- Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component

- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC
Stage IV) RCC

- No prior systemic therapy for RCC with the following exception:

1. One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such
therapy did not include an agent that targets vascular endothelial growth factor
(VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the
last dose of adjuvant or neoadjuvant therapy

- Karnofsky Performance Status (KPS) of at least 70%

- Measurable disease as per Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1

- Tumor tissue [formalin-fixed paraffin-embedded (FFPE) archival or recent
acquisition] must be received by the central vendor (block or unstained
slides) in order to randomize a subject to study treatment. (Note: Fine
Needle Aspiration [FNA] and bone metastases samples are not acceptable for
submission)

Exclusion Criteria:

- Any history of or current central nervous system (CNS) metastases. Baseline imaging of
the brain is required within 28 days prior to randomization

- Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but
not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab)

- Prior treatment with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD-L2,
anti-CD137, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other
antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

- Any active or recent history of a known or suspected autoimmune disease or recent
history of a syndrome that required systemic corticosteroids (>10 mg daily Prednisone
equivalent) or immunosuppressive medications except for syndromes which would not be
expected to recur in the absence of an external trigger. Subjects with vitiligo or
type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only
requiring hormone replacement are permitted to enroll

- Any condition requiring systemic treatment with corticosteroids (>10 mg daily
Prednisone equivalents) or other immunosuppressive medications within 14 days prior to
first dose of study drug. Inhaled steroids and adrenal replacement steroid doses >10
mg daily Prednisone equivalents are permitted in the absence of active autoimmune
disease
We found this trial at
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sites
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
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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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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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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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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Allentown, Pennsylvania 18105
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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Atlanta, Georgia 30322
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Baltimore, Maryland 21201
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Berazategui, Buenos Aires
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330 Brookline Avenue
Boston, Massachusetts 02215
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlotte, North Carolina 28211
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Chattanooga, Tennessee 37403
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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Dallas, Texas 75246
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
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Detroit, Michigan 48201
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Duarte, California 91010
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Fairway, Kansas 66205
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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La Jolla, California 92093
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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New Haven, Connecticut 06520
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1275 York Ave
New York, New York 10021
(212) 639-2000
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Philadelphia, Pennsylvania 19111
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5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
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Stanford, California 94305
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Tampa, Florida 33612
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
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