Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies

Inclusion criteria

Inclusion criteria

include, but are not limited to, the following:

• Confirmed diagnosis of solid tumor malignancy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate hepatic, renal and bone marrow function
• Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1

Exclusion criteria

Exclusion criteria

include, but are not limited to, the following:

• Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
• Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg
• Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
• Patients with deep vein thrombosis or pulmonary embolism within last 3 months
• Patients with serious non healing wound or acute ulcer
• Patients with treatment resistant or bleeding peptic ulcer disease, erosive esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic event within last 3 months
• Patients with history of abdominal or tracheal-esophageal fistula
• Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors
• Prior treatment with bevacizumab within last 6 weeks
• Pregnant or breast-feeding women