Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma

Exclusion Criteria

• •CNS metastases
• •Pregnant or nursing women
• •Prior therapy with bevacizumab or ipilimumab
• •Active infection
• •Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic autoimmune disease
• •Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
• •Any underlying medical condition which, in the principal investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events
• •Any concurrent medical condition requiring the use of systemic steroids
• •Inadequately controlled hypertension
• •Any prior history of hypertensive crisis or hypertensive encephalopathy
• •NYHA Grade II or greater congestive heart failure
• •History of myocardial infarction or unstable angina within 6 months prior to study enrollment
• •History of stroke of transient ischemic attack within 6 months prior to study enrollment
• •Significant known vascular disease
• •Symptomatic peripheral vascular disease
• •Evidence of bleeding diathesis or coagulopathy
• •Major surgical procedure or significant traumatic injury within 28 days prior to study enrollment
• •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
• •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
• •Serious, non-healing wound, ulcer or bone fracture
• •Proteinuria at screening
• •Known hypersensitivity to any component of bevacizumab
• •History of hemoptysis within 3 months prior to study enrollment
• •Current, ongoing treatment with full-dose warfarin or its equivalent
• •Current or recent (within 10 days of enrollment) use of aspirin (\>325mg/day) or chronic use of other NSAIDs
• •Medications that inhibit platelet function
• •Known involvement of melanoma within gastrointestinal tract
• •Ulcerated skin lesions