Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer

Inclusion Criteria

• Patients with metastatic renal cell carcinoma
• Patients with at least one measurable lesion
• Patients with progressive metastatic renal cell carcinoma
• Patients who had a prior partial or complete nephrectomy
• Patients with a Karnofsky Performance Status ≥70%.
• Adequate bone marrow function
• Adequate liver function
• Adequate renal function
• Adequate coagulation profile

Exclusion Criteria

• 4 weeks post-major surgery
• Patients who had radiation therapy within 28 days prior to start of study
• Patients in need for major surgical procedure during the course of the study.
• Patients with a serious non-healing wound, ulcer, or bone fracture.
• Patients with a history of seizure(s) not controlled with standard medical therapy.
• Patients who have received prior systemic treatment for their metastatic RCC.
• Patients who received prior therapy with VEGF pathway inhibitor
• Patients who have previously received systemic mTOR inhibitors
• Patients with a known hypersensitivity RAD001 (everolimus) or other rapamycins or to its excipients.
• Patients with history or current central nervous system (CNS) metastases or spinal cord compression.
• Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
• Patients with proteinuria at screening.
• Patients with inadequately controlled hypertension
• Patients receiving ongoing or with recent need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin
• Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
• Patients with a known history of HIV
• Patients with hypersensitivity to interferon alfa-2a or any component of the product.
• Patients with an active, bleeding diathesis or coagulopathy or recurrent thromboembolism
• Patients who have any severe and/or uncontrolled medical conditions or other conditions
• Left Ventricular Ejection Fraction < lower limit of institutional normal assessed by ECHO or MUGA
• Patients who have a history of another primary malignancy ≤ 3 years
• Female patients who are pregnant or breast feeding
• Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
• Patients unwilling to or unable to comply with the protocol

Other protocol-defined inclusion/exclusion criteria may apply