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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

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Trial Information

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


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Every clinic visit (every 2-4 weeks) up to 42 months

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

CA209-025

NCT ID:

NCT01668784

Start Date:

October 2012

Completion Date:

February 2016

Related Keywords:

  • Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
University of Colorado Denver, Colorado  80217
Cancer Therapy and Research Center San Antonio, Texas  78229
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Seattle Cancer Care Alliance Seattle, Washington  98109
Duke University Medical Center Durham, North Carolina  27710
Northwestern University Chicago, Illinois  60611
The Ohio State University Columbus, Ohio  43210
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
USC Norris Comprehensive Cancer Center Los Angeles, California  90089
Local Institution Indianapolis, Indiana  
Local Institution Bronx, New York  
Georgetown University Medical Center Washington, District of Columbia  20007
Virginia Cancer Institute Richmond, Virginia  23230
UCSD Moores Cancer Center La Jolla, California  93093
Local Institution Corona, California  
Local Institution Wilmington, North Carolina  
Local Institution Duncansville, Pennsylvania  
Local Institution Austin, Texas  
Local Institution Little Rock, Arkansas  
Local Institution Iowa City, Iowa  
Winship Cancer Institute, Emory University Atlanta, Georgia  30322
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009
Karmanos Cancer Center Detroit, Michigan  48201
University of Michigan Health System Ann Arbor, Michigan  
Loyola University Chicago Maywood, Illinois  60153
St. Francis Hospital Greenville, South Carolina  29601
Stanford Cancer Institute Stanford, California  94305
Cedar Sinaï Medical Center Los Angeles, California  CA90048