An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/3/2018
Start Date:November 30, 2015
End Date:December 1, 2021

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A Phase 3b/4 Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 374)

This study will generate safety data on Nivolumab given by itself in treatment of advanced
Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related
side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with
Nivolumab.


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

Inclusion Criteria:

- Advanced or Metastatic renal cell carcinoma (RCC)

- Predominant clear cell histology:

1. At least 1 but no more than 2 prior systemic anti vascular endothelial growth
factor (anti-VEGF) treatments

2. No more than 3 total prior systemic treatment regimens in the advanced or
metastatic setting

3. Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are
eligible

- Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor

- Brain metastases allowed if asymptomatic, without edema, and not receiving
corticosteroids or radiation

- Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)

- All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed

Exclusion Criteria:

- Subjects with any active autoimmune disease or a history of known autoimmune disease

- History of severe hypersensitivity reaction to other monoclonal antibodies

- Prior malignancy, active within the last 3 years, except for locally curable cancers
which have been apparently cured

- Known HIV or AIDS-related illness

- Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic
infection
We found this trial at
49
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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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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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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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Aurora, Colorado 80045
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Charleston, South Carolina 29403
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Chattanooga, Tennessee 37404
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Dallas, Texas 75246
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DFW Airport, Texas 75063
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DFW Airport, Texas 75063
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DFW Airport, Texas 75063
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DFW Airport, Texas 75063
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Fort Myers, Florida 33916
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Fort Wayne, Indiana 46845
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Fort Worth, Texas 76104
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Fullerton, California 92835
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Germantown, Tennessee 38138
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Grand Junction, Colorado 81501
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Hackensack, New Jersey 07601
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Houston, Texas 77024
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Johnson City, New York 13790
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Kansas City, Missouri 64132
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Lakewood, Colorado 80228
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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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Los Angeles, California 90095
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514 North Prospect Avenue
Los Angeles, California 90095
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Louisville, Kentucky 40207
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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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Niles, Illinois 60714
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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17607 Gold Plaza
Omaha, Nebraska 68130
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Paris, Texas 75460
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Phoenix, Arizona 85016
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5050 Northeast Hoyt Street
Portland, Oregon 97213
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Richmond, Virginia 23235
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Saint Petersburg, Florida 33705
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Santa Maria, California 93454
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Spokane, Washington 99216
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Springfield, Oregon 97477
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Tampa, Florida 33612
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West Palm Beach, Florida 33401
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