VALTIVE1 Study

[OvacomeSupport]

Hello All

We have been asked by researchers to let you know about a trial called VALTIVE1.

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

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.

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The usual treatment for ovarian cancer is a combination of surgery and chemotherapy. You might also have extra treatment with a targeted drug [Gloss/targeted drug] 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 [Gloss/Biomarker]) 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. 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 or elsewhere in the body (stage 3 or 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 [Gloss/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 [Gloss/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 biomarker [Gloss/Biomarker] study collecting extra blood samples. So taking part won’t affect or change your treatment.

Treatment

Everyone who takes part will receive 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 [Gloss/Cycles of treatment].

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. 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 [Gloss/Biopsy]) 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 according to the standard of care practice at your hospital.

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:

•carboplatin

•paclitaxel

•bevacizumab

•surgery for ovarian cancer

Chief Investigator

Professor Gordon Jayson, The University of Manchester and the Christie NHS Foundation Trust

Supported by

Cancer Research UK

Other information

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

If you would be interested in taking part in VALTIVE, please talk to your oncologist about a referral to a participating trial centre. Currently it is running at the following centres, although more are planned.

Christie Hospital

Royal United Hospitals Bath

University Hospital Southampton

Mount Vernon Cancer Centre

Royal Marsden NHS Foundation Trust

UCLH

Velindre Cancer Centre, Cardiff

Kettering General Hospital

Best wishes

Anna

Ovacome Support

[Tillymint61]

I am not eligible but this test they are trialling would have made such a difference in the course of my treatment. I had 11 beve.treatments before it was decided it wasn't working. The stress of knowing my marker and symptoms where getting worse was unbeatable for 6 months if they had known within weeks and stopped it would have made a massive difference to my mental well being and who knows maybe have helped my longer term outcomes I was on trial icon8b but randomised onto the control group so received standard of care treatment for 1st line treatment.

[OvacomeSupport Partner My Ovacome Team in reply to Tillymint61]

Hello Tillymint61

Thank you for your reply and for sharing your experience. I’m so sorry to hear what a stressful time this was for you. If you would ever like to talk things through with a member of the Ovacome support team, please don’t hesitate to call our support line on 0800 008 7054 or 07503 682 311. We’re here Monday – Friday, 10am – 5pm, to talk through questions, provide information of just to have a friendly chat.

Best wishes

Annie

Ovacome support