A study of the new Tie2 blood test in women having bevacizumab for ovarian cancer (VALTIVE1)
Cancer type:
Status:
Phase:
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 
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 () test. It tells doctors after a few weeks of starting treatment whether bevacizumab is working or not.
Some people might also have a drug called olaparib in combination with bevacizumab. This is if your doctor finds you have some gene changes () in your cancer cells.
Olaparib is a called a PARP inhibitor. PARP is a protein that helps damaged cells repair themselves. By blocking PARP cancer cells can’t repair themselves and so they die.
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 aims of this study are to:
- confirm that the Tie2 blood test works in women having bevacizumab for ovarian cancer
- see if adding olaparib to bevacizumab affects the Tie2 blood test
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 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 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 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. Some people will also have olaparib if they have certain gene changes in their cancer cells. Your doctor can tell you more about this.
The chemotherapy drugs are carboplatin and paclitaxel. You have them as a drip into a vein once every 3 weeks. You have at least 6 .
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.
Olaparib is a tablet. You take it twice a day every day in combination with bevacizumab. You have this for up to 15 months. You then have olaparib on its own for up to 9 months.
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
They team ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
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 () 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.
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
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.
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.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
