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Clinical Trial DRUG CA209025

Title
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
Principal Investigator
Timothy Kuzel
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG CA209025
Purpose
The purpose of this study is to compare the effectiveness of an experimental drug called BMS-936558 versus Everolimus in treating renal cell carcinoma.
Overview
BMS-936558 is an investigational new drug that is believed to boost the immune system to help it recognize and attack cancer cells. It does this by blocking a specific protein in the body that can cause T-lymphocytes (cells of the immune system) to stop working. BMS-936558 has not been approved by the Federal Drug Administration (FDA). Everolimus is a FDA approved standard treatment.
Eligibility
Some of the eligibility criteria include:
  • Participants must be 18 years or older.
  • Participants must have advanced or metastatic clear cell renal cell cancer (it spread beyond the kidney).
  • Participants must have received one or two prior anti-angiogenic therapy regimens (anti-angiogenic drug is one that controls the growth of blood vessels to the tumor, such as Bevacizumab). Please discuss all prior treatments with the study doctor.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants will be randomized (assigned by chance like flipping a coin) into one of two groups known as arms; Arm A or Arm B. Arm A will receive BMS-936558 and Arm B will receive Everolimus. Both Arms are on a 4-week (28 day) cycle of treatment.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 25-Oct-14 02:01 AM

 

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