Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:12/20/2018
Start Date:September 27, 2012
End Date:August 14, 2019

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A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

The purpose of the study is to compare the clinical benefit, as measured by duration of
overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic
clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy


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

Inclusion Criteria:

- Men & women ≥18 years of age

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

- Advanced/metastatic RCC

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

- Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic
setting

- No more than 3 total prior systemic treatment regimens in the advanced or metastatic
setting, and evidence of progression on or after last treatment regimen received and
within 6 months of enrollment

- Karnofsky Performance Score ≥70%

Exclusion Criteria:

- Any Central Nervous System (CNS) metastases or history of CNS metastases

- Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor

- Any active known or suspected autoimmune disease

- Uncontrolled adrenal insufficiency

- Active chronic liver disease

- Prior malignancy active within past 3 years, except for locally curable cancers
We found this trial at
38
sites
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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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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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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Buffalo, NY
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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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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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San Francisco, CA
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Atlanta, Georgia 30322
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Aurora, Colorado 80045
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Berazategui, Buenos Aires
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28211
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303 East Superior Street
Chicago, Illinois 60611
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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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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Detroit, Michigan 48201
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Fayetteville, Arkansas 72703
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Greenville, South Carolina 29601
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46202
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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La Jolla, California 92093
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Maywood, Illinois 60153
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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 York, New York 10021
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Philadelphia, Pennsylvania 19111
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Richmond, Virginia 23235
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7979 Wurzbach Road
San Antonio, Texas 78229
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Stanford, California 94305
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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