VALTIVE1

VALTIVE1: Validation of Tie2 as the first tumour vascular response biomarker for VEGF inhibitors: Optimising the design of a subsequent randomised discontinued trial.

Short description

In VALTIVE1 blood samples are taken from patients who are receiving a VEGFi (Vascular Endothelial Growth Factor inhibitor) called bevacizumab for ovarian cancer. In the qualitative sub-study, interviews take place with participants of this trial to explore their experiences of the trial and treatments and their views on a future trial. The results of the trial and qualitative study will be used to design a second trial which will aim to demonstrate conclusively the value of the Tie2 test.

Background

Tumour angiogenesis (formation of new blood vessels, which is essential to the process of tumour metastasis) can be controlled by Vascular Endothelial Growth Factor (VEGF). Drugs blocking VEGF, known as VEGF inhibitors (VEGFi) are now widely used in cancer medicine for postponing recurrence of the disease. In ovarian cancer, bevacizumab (VEGF inhibitor) is used in the treatment of ovarian cancer in combination with chemotherapy and surgery. However, VEGFi have side effects for the patient, are toxic, and expensive. Until now there have been no biomarker (Tie2) that could be used to identify whether the VEGF inhibitors are working. This trial will test whether the Tie2 level increases, which indicates that the blood vessels have escaped the control of VEGFi.

Aims

Primary objective

The trial will define the Progression Free Survival (PFS) advantage of Tie2-defined vascular responders vs Tie2-defined vascular non-responders in patients receiving bevacizumab for high-risk Ovarian Cancer.

Secondary objective

To define the relationship between Tie2-defined vascular progression and disease progression assessed according to RECIST v. 1.1 criteria.

Aims of Qualitative-Sub Study

The aim of the embedded qualitative study is to assess acceptability, feasibility of recruitment, and patient perspectives to inform the design of the future randomised trial.

Methods

Progress

Data collection for the qualitative component has been completed.

Impact

Initial findings have been fed back to inform the trial and VALTIVE2.

Information