A study of the new Tie2 blood test in women having bevacizumab for ovarian cancer (VALTIVE1)

Cancer type:

Ovarian cancer
Secondary cancers

Status:

Open

Phase:

Other

This study is measuring the level of a biomarker in the blood to work out early on if bevacizumab is working. 

It is for women whose cancer has spread outside the pelvis or elsewhere in the body and who have:

  • ovarian cancer,
  • primary peritoneal cancer or 
  • fallopian tube cancer

These cancers are treated in a similar way. When we use the term ovarian cancer in this summary, we are referring to all 3.

Cancer Research UK supports this trial. 

More about this trial

The usual treatment for ovarian cancer is a combination of surgery and chemotherapy. You might also have extra treatment with a targeted drug Open a glossary item called bevacizumab for up to a year. This long term treatment is to keep the cancer under control and delay cancer growth. It is called maintenance treatment. 

Bevacizumab blocks a growth factor (like a hormone) that makes blood vessels. This growth factor is called VEGF. Blocking this protein stops the cancer from growing blood vessels, so it is starved and can't grow. 

Bevacizumab works well for some people with ovarian cancer but not all. And like all cancer treatments it can cause side effects. You also need regular trips to hospital to have it. Rather than waiting for scan results researchers think it is important to know as soon as possible if it’s working or not.

They have discovered a new blood (biomarker Open a glossary item) test. It tells doctors after a few weeks of starting treatment whether bevacizumab is working or not.

The team hope to develop the blood test further in a large study so that they can use it in the NHS. Before they do this, they need to first check their findings. So they are running this small study to collect blood samples from women having bevacizumab. 

The main aim of this study is to confirm that the Tie2 blood test works in women having bevacizumab for ovarian cancer. 

Please note, your treatment will not be changed if you agree to take part in this study.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this study if all of the following apply. You:

  • have ovarian, primary peritoneal or fallopian tube cancer
  • have cancer that has spread outside the pelvis (the trial includes some people with stage 3 cancer) or the cancer has spread elsewhere in the body (stage 4)
  • are due to start bevacizumab or a drug similar to bevacizumab (biosimilar medicine)
  • will have at least 2 doses of bevacizumab before surgery or the plan is to start bevacizumab after surgery
  • are suitable to have first line treatment Open a glossary item for ovarian cancer that includes the drugs carboplatin and paclitaxel chemotherapy every 3 weeks
  • are willing to have blood samples taken as part of the trial 
  • are willing to use reliable contraception if there is any chance you could become pregnant
  • are at least 16 years old

Who can’t take part

You cannot join this study if any of these apply. You:

  • can’t have a VEGF Open a glossary item treatment such as bevacizumab
  • are taking part in another treatment trial 
  • are known to have HIV or you have an active Hepatitis B or Hepatitis C infection 
  • are pregnant or breastfeeding

Trial design

The study team hope to find 176 women to take part. This study is taking place in the UK. 

This a biomarker Open a glossary item study collecting extra blood samples. So taking part won’t affect or change your treatment. 

Treatment
Everyone who takes part will have chemotherapy and bevacizumab. 

The chemotherapy drugs are carboplatin and paclitaxel. You have them as a drip into a vein once every 3 weeks. You have up to 6 cycles of treatment Open a glossary item.

You have bevacizumab as a drip into a vein. You have this once every 3 weeks for up to a year. Your doctor tells you when you start bevacizumab.

You may also need to have surgery halfway through your chemotherapy  Your doctor will tell you more about having surgery and when you have it.

Blood samples for VALTIVE1 research 
As part of this study you give up to 11 extra blood samples. You give these:

  • before the first 4 cycles of bevacizumab
  • when you finish chemotherapy and then
  • every 3 months while you are having bevacizumab
  • if your cancer starts to grow again 

 You give the samples when you have your routine blood samples taken. 

What researchers do with the blood samples 
Researchers measure the levels of a protein in the bloodstream called Tie2. For example, they know that bevacizumab seems to work best when it reduces the levels of Tie2 in blood. Looking at the levels of Tie2 helps them to see whether bevacizumab has worked. And this helps them to work out whether Tie2 is a useful test or not. 

The researchers also compare the Tie2 levels with your scan results.  

If this study confirms the test works, the team plan to design another much larger study to confirm their data. That study will be called VALTIVE2. We plan to add a summary when it opens. 

Other research samples 
The team are running 2 extra studies as part of VALTIVE1. These are looking at blood and tissue samples. 

Surgery and the Tie2 blood test 
Surgery involves cutting tissue which is followed by wound healing. These processes affect blood vessels and so the researchers need to test what impact surgery will have on Tie2 levels. Your doctor may ask to take some extra blood samples before and after surgery. 

Tissue sample study
The team would also like to collect samples of tissue (biopsies Open a glossary item) from people whose level of Tie2 has increased in the blood. The team plan to use the samples to look at blood vessels within the cancer. This research is only for people having their treatment in Manchester. 

You don’t have to agree to take part in either of these extra studies if you don’t want to. It won’t affect you taking part in the main study. 

Interviews
The team may ask you to take part in an interview with a researcher. They plan to ask you about taking part in study to understand:

  • how you would feel about having this type of blood or biomarker test
  • how you would feel about your doctor changing treatment based on the results from the test

Researchers hope this information will help them to design the bigger study they plan to do. You don’t have to agree to take part in the interview if you don’t want to.

Hospital visits

You see a doctor and have some tests before you start treatment. These include:

  • physical examination 
  • blood tests
  • urine tests
  • measuring your blood pressure 
  • CT scan (if you haven’t had a recent one)

During treatment you have a CT scan:

  • before you start bevacizumab
  • when you finish chemotherapy
  • regularly while you are having bevacizumab. How often you have these scans depends on the hospital where you are having treatment. 

All of the above are routine tests and scans you have before starting chemotherapy and bevacizumab. You would have them even if you weren’t taking part in this study.

You give extra blood samples for the biomarker blood test. Where possible you have them at the same time as your routine samples. 

You shouldn’t have extra hospital visits if you join this study.

Side effects

There are no extra side effects as a result of taking part in this study. 

Your doctor will talk to you about all the possible side effects of your routine treatment. 

We have information about:

Location

Bath
Cardiff
London
Manchester
Northwood
Southampton
Sutton

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Gordon Jayson

Supported by

Cancer Research UK
University of Manchester

Other information

This is Cancer Research UK trial number CRUK/19/015.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17183

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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