Conditions: Renal Cell Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 649
Healthy volunteers: no

Brief summary:
This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (\>)500 individuals.

Detailed description:

Arms:
arm 1: Bevacizumab infusions will be administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) will be administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity. arm 2: Placebo matched with Bevacizumab infusions will be administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A will be administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.

Interventions: intervention 1: Bevacizumab [Avastin] intervention 2: Interferon alfa 2a [Roferon] intervention 3: Placebo
Intervention descriptions: intervention 1: 10 mg/kg IV every 2 weeks intervention 2: 9 MIU SC 3 times/week intervention 3: IV every 2 weeks

Protocol document: