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