Validation of Tie2 as the First Tumour Vascular Response Biomarker for VEGF Inhibitors: VALTIVE1

VALTIVE1 is a multi-centre, single arm, non-interventional biomarker study, which will enrol 176 participants who are 16 years or older and who have FIGO stage IIIc/ IV ovarian cancer on treatment with first-line platinum-based chemotherapy and bevacizumab. Potential participants will be identified at their treating hospital. The definition of vascular response is either (i) stable or reduced concentrations of Tie2 after 6 weeks of treatment or (ii) a confirmed reduction in plasma Tie2 of \>10% within 9 weeks of starting treatment. Patients enrolled into the VALTIVE 1 study will provide blood samples twice before treatment with bevacizumab and then at the end Cycles 1, 2, and 3, at the end of cytotoxic chemotherapy, at 3 months, 6 months, 9 months, at the end of treatment, and at disease progression. The early samples will be used to refine the definition and number of required samples needed to define a Tie2-vascular response. Samples collected at 3 months, 6 months, 9 months, at the end of treatment, and at disease progression will be used to investigate the relationship between Tie2-defined vascular progression and RECIST1.1- or clinically-defined Progression Disease (PD). While the patients receive single agent maintenance bevacizumab, patients will undergo RECIST1.1 scanning at 3 months, 6 months, 9 months, end of treatment and at disease progression, if not before. These scans will also be reported to RECIST 1.1. Progressive disease will be defined by the date of radiological or clinically identified progressive disease or death.