Conditions: Renal Cell Carcinoma
Keywords: temsirolimus renal cell carcinoma kidney cancer urogenital cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 791
Healthy volunteers: no

Brief summary:
Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.

Detailed description:

Arms:
arm 1: Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly arm 2: Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW

Interventions: intervention 1: Bevacizumab intervention 2: Temsirolimus intervention 3: Bevacizumab intervention 4: Interferon-Alfa 9MU
Intervention descriptions: intervention 1: Bevacizumab 10 mg/kg intravenous (IV) q8wks intervention 2: Temsirolimus 25 mg IV weekly intervention 3: Bevacizumab 10 mg/kg intravenous (IV) q8wks intervention 4: Interferon-Alfa 9MU SC TIW

Protocol document: