BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
NCT ID: NCT01354431
Last Updated: 2022-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
168 participants
INTERVENTIONAL
2011-05-31
2021-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1: nivolumab - 0.3 mg/kg
nivolumab
Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Arm 2: nivolumab - 2.0 mg/kg
nivolumab
Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Arm 3: nivolumab - 10.0 mg/kg
nivolumab
Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Interventions
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nivolumab
Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
nivolumab
Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
nivolumab
Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previous treatment with at least one anti-angiogenic agent
* Progressed within 6 months of study enrollment
* Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease
* Must have available tumor tissue for submission
* Subjects must also meet various laboratory parameters for inclusion
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ono Pharma USA Inc
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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UCSD Moores Cancer Center
La Jolla, California, United States
Ucla
Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Inst.
Los Angeles, California, United States
Stanford Cancer Center
Stanford, California, United States
University Of Colorado
Aurora, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, United States
University Of Kansas Medical Center
Kansas City, Kansas, United States
University Of Maryland
Baltimore, Maryland, United States
The Bunting-Blaustein Cancer Research Building
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Ctr.
Boston, Massachusetts, United States
University Of Michigan Medical Center
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Masonic Cancer Ctr, University Of Minnesota
Minneapolis, Minnesota, United States
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo, Mississippi, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
St. Luke'S Roosevelt Hospital Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Memorial Sloan Kettering Nassau
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Blumenthal Cancer Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Wheaton Franciscan Health Care
Wauwatosa, Wisconsin, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Centre D'Oncologie Dr-Leon-Richard
Moncton, New Brunswick, Canada
Local Institution
Halifax, Nova Scotia, Canada
London Regional Cancer Program
London, Ontario, Canada
Centre Hospitalier Universitaire De Montreal-Notre-Dame Hosp
Montreal, Quebec, Canada
Local Institution
Helsinki, , Finland
Local Institution
Siena, , Italy
Countries
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References
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George S, Motzer RJ, Hammers HJ, Redman BG, Kuzel TM, Tykodi SS, Plimack ER, Jiang J, Waxman IM, Rini BI. Safety and Efficacy of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Treated Beyond Progression: A Subgroup Analysis of a Randomized Clinical Trial. JAMA Oncol. 2016 Sep 1;2(9):1179-86. doi: 10.1001/jamaoncol.2016.0775.
Motzer RJ, Rini BI, McDermott DF, Redman BG, Kuzel TM, Harrison MR, Vaishampayan UN, Drabkin HA, George S, Logan TF, Margolin KA, Plimack ER, Lambert AM, Waxman IM, Hammers HJ. Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial. J Clin Oncol. 2015 May 1;33(13):1430-7. doi: 10.1200/JCO.2014.59.0703. Epub 2014 Dec 1.
George S, Pili R, Carducci MA, Kim JJ. Role of immunotherapy for renal cell cancer in 2011. J Natl Compr Canc Netw. 2011 Sep 1;9(9):1011-8. doi: 10.6004/jnccn.2011.0085.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-010
Identifier Type: -
Identifier Source: org_study_id
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