Clinical Trial DRUG CA209025
- 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
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CA209025
- The purpose of this study is to compare the effectiveness of an experimental drug called BMS-936558 versus Everolimus in treating renal cell carcinoma.
- 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.
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.
- 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.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 08-Oct-15 04:56 PM
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