An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
NCT ID: NCT02596035
Last Updated: 2022-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
197 participants
INTERVENTIONAL
2016-01-08
2021-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Nivolumab
Nivolumab dose as specified
Nivolumab
Interventions
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Nivolumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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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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Local Institution - 0030
Phoenix, Arizona, United States
Comprehensive Blood And Cancer Center
Bakersfield, California, United States
St. Jude Hospital Yorba Linda
Fullerton, California, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, United States
University Of Colorado
Aurora, Colorado, United States
Local Institution - 0028
Grand Junction, Colorado, United States
Local Institution - 0018
Lakewood, Colorado, United States
Local Institution - 0008
Fort Myers, Florida, United States
Baptist Health Medical Group Oncology
Miami, Florida, United States
Local Institution - 0007
St. Petersburg, Florida, United States
Local Institution - 0054
Tampa, Florida, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Local Institution - 0052
Fort Wayne, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States
HCA Midwest Division
Kansas City, Missouri, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C.
Lincoln, Nebraska, United States
Local Institution - 0011
Omaha, Nebraska, United States
Urology Cancer Center Laboratory
Omaha, Nebraska, United States
Local Institution - 0014
Las Vegas, Nevada, United States
Local Institution - 0053
Buffalo, New York, United States
Broome Oncology
Johnson City, New York, United States
Local Institution - 0055
New York, New York, United States
Local Institution - 0001
Tulsa, Oklahoma, United States
Local Institution - 0016
Portland, Oregon, United States
Local Institution - 0020
Charleston, South Carolina, United States
Local Institution - 0005
Chattanooga, Tennessee, United States
Local Institution - 0012
Germantown, Tennessee, United States
Local Institution - 0004
Nashville, Tennessee, United States
Local Institution - 0015
Dallas, Texas, United States
The Center For Cancer And Blood Disorders
Fort Worth, Texas, United States
Local Institution - 0034
Houston, Texas, United States
Local Institution - 0021
San Antonio, Texas, United States
Texas Cancer Center - Sherman
Sherman, Texas, United States
Local Institution - 0032
Norfolk, Virginia, United States
Local Institution - 0047
Richmond, Virginia, United States
Local Institution - 0017
Roanoke, Virginia, United States
Local Institution - 0039
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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2015-003286-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-374
Identifier Type: -
Identifier Source: org_study_id
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