A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R)

Inclusion Criteria: * Signed Informed Consent Form * Histologically confirmed metastatic RCC * Measurable disease, as defined by RECIST * Age ≥ 18 years * ECOG performance status of 0 or 1 * Prior nephrectomy * Ability and capacity to comply with study and follow-up procedures Exclusion Criteria: * RCC with predominantly sarcomatoid features * Prior systemic or adjuvant therapy for RCC * Radiotherapy for RCC within 28 days prior to Day 1 * Prior treatment with bevacizumab, sunitinib, sorafenib, axitinib, thalidomide, or other similar agents * Current need for dialysis * Life expectancy of \< 12 weeks * Current, recent, or planned participation in an experimental drug study * Inadequate organ function * Active infection or fever \> 38.5°C within 3 days of starting treatment * History of other malignancies within 5 years prior to Day 1 * Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results * Inadequately controlled hypertension * Prior history of hypertensive crisis or hypertensive encephalopathy * New York Heart Association (NYHA) Class II or greater CHF * History of myocardial infarction or unstable angina within 6 months prior to Day 1 * History of stroke or transient ischemic attack within 6 months prior to Day 1 * Known CNS disease except for treated brain metastasis * Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1 * History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) * Major surgical procedure or anticipation of need for major surgical procedure during the course of the study * Serious, non-healing wound; active ulcer; or untreated bone fracture * Known hypersensitivity to any component of bevacizumab * Pregnancy (positive pregnancy test) or lactation * Current, ongoing treatment with full-dose warfarin