VALTIVE1

Status: Open

Specialty: Gynae

Date Opened: 16/06/2022

Planned Close Date: 30/11/2023

Sponsor: CRUK Clinical Trials Unit Kings College London

Principal Investigator: Dr Dennis Hadjiyiannakis

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

Tumours require a blood supply to provide them with oxygen and nutrients and to enable spread of cancer to other organs (metastasis). New blood vessel formation is known as angiogenesis, which is controlled by a growth factor (like a hormone) called Vascular Endothelial Growth Factor (VEGF). Many drugs have been developed that block VEGF and, in most cancers, including ovarian cancer, the addition of VEGF inhibitors (VEGFi) to conventional anti-cancer therapy postpones recurrence of the disease and in some cases improves the overall outcome. VEGFi are widely used in cancer medicine. Yet, until now, there have been no biomarkers (tests) that could be used to tell patients and their doctors whether the drugs were working.

In their initial studies in ovarian and bowel cancer, Prof Jayson’s team discovered the first biomarker that tells us whether a VEGFi is working. The test involves measuring a protein in the blood called Tie2, which can be measured from routine blood tests. When Tie2 decreases in the blood, we know that tumour blood vessels are blocked by VEGFi and the treatment is working; when the level increases, we know that the blood vessels have escaped the control of VEGFi and treatment should be changed. However, further research is required to establish the test in the NHS to support clinical decision making.

In VALTIVE1 study, we would like to collect blood samples from patients with advanced ovarian cancer who are receiving a specific type of VEGFi called bevacizumab as part of their standard of care. The aim of VALTIVE1 is to generate a comprehensive biomarker data set that describes how Tie2 responds to treatment with bevacizumab. The data set will be used to design VALTIVE2, which will be a randomised trial with the aim of proving conclusively the value of Tie2 test.