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
This research is being done to compare the effectiveness (how well the drug works), safety, and tolerability of an investigational drug, BMS-936558, as compared to the approved drug, everolimus, in subjects with advanced or metastatic renal cell carcinoma. BMS-936558 is an antibody (a type of human protein) that is being tested to see if it will allow the bodyâ??s immune system to work against tumor cells.
Must be at least 18 years of age,confirmation of Renal Cell Cancer with a clear cell component, must be advanced or metastatic, must have measurable disease, must have received one or two prior anti-angiogenic therapy regimens, must have received no more than three total prior systemic treatment regimens in the advanced or metastatic setting, must have evidence of progression on or after the last treatment regimen received and within 6 months prior to study enrollment, must have good body function, must be willing to use a highly effective method of birth control if able to have children, must have good blood/liver/kidney function, must not have any history of or current brain metastasis, no prior treatment with an mTOR inhibitor
After signing informed consent patients will be screened for eligibility including blood work/ physical exams,/CTs or MRIs/among others, after eigibility is confirmed patients will be randomized to receive one of two treatments: Arm A will receive BMS-936558 via an IV infusion over 60 minutes every 2 weeks (on Days 1 & 15 of a 28 day cycle), blood samples will be performed at various time points during the study drug infusion and after, patients will be rescanned after 2 cycles and will be allowed to continue with the study if disease remains stable or improves, Arm B will receive everolimus orally daily for a 28 day cycle. Minimal blood samples for study research will be obtained in Arm B, patients willed be rescanned as in Arm A and will also be allowed to continue with the study if disease remains stable or improves, the study drugs will both be provided free of charge to patients.
12/11/2013 04:02 AM