
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
This study is looking at MIV-818 in combination with lenvatinib or pembrolizumab for people with
Lenvatinib is a called a cancer growth blocker. It works by stopping signals that tell cancer cells to grow. It also stops the cancer forming new blood vessels. Cancer cells need blood vessels to keep growing.
Doctors already use lenvatinib to treat liver cancer.
Pembrolizumab is an immunotherapy. It works by stimulating the to fight cancer cells.
In the UK doctors don’t use pembrolizumab to treat liver cancer. But research shows that pembrolizumab might help people with liver cancer.
MIV-818 is a prodrug. In the body it is changed to a drug that works in the same way as chemotherapy. So, it works by affecting the of the cancer cells. Studies done in the laboratory show that MIV-818 might help people with liver cancer.
This study has 2 stages. In the first stage the team found the best dose of MIV-818 to have by itself. The best dose is the highest dose with the fewest side effects.
The first stage has finished. The team found the best dose of MIV-818 to have by itself.
In the second stage you have MIV-818 with lenvatinib or pembrolizumab. It is your doctor’s decision whether you have lenvatinib or pembrolizumab.
The aims of this study are to find:
The following bullet points are a summary of 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.
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You have:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You:
This is an international phase 1/2 study. There are 2 stages in the study.
In the first stage the team found the best dose of MIV-818 to have by itself. The best dose is the highest with the fewest side effects. This stage is now completed.
In the second stage the team want to find the best dose of MIV-818 to have with lenvatinib. And also the best dose of MIV-818 to have with pembrolizumab.
For this stage they need up to 66 people to join worldwide.
After talking to you the doctor decides whether you have lenvatinib or pembrolizumab.
You have . Each treatment cycle is 21 days.
MIV-818 are capsules. You take them once a day for the first 5 days of each treatment cycle. You take them in the morning without food or after a light breakfast.
You have a diary to fill in when you take MIV-818. You must bring this with you when you go to the hospital for your clinic appointments.
Lenvatinib are capsules. You take them every day during the treatment cycle.
You have pembrolizumab as a drip into a vein. You have it once at the start of the treatment cycle. You have it at the hospital and it takes about 30 minutes.
You continue with treatment as long as it is helping and the side effects aren’t too bad.
Samples for research
You give several blood samples for research during the study. Where possible the team take these samples when you have blood taken for routine blood tests. The team will tell you how many and how often they will take these samples.
The team take a sample of liver tissue () during treatment. They will tell you when they want to take the sample.
They will ask for another tissue sample further on in treatment. This sample is optional you don’t have to agree to have it taken.
Researchers will use these blood and tissue samples to find:
You see the doctor for tests before taking part. These include:
You see the doctor regularly during treatment for blood tests and to see how you are.
You have a CT scan and MRI scan every 6 weeks while having treatment.
A month after you stop taking MIV-818 you see the doctor for:
You then see the doctor as part of the study at 3 months and 6 months. They will then tell you how often they want to see you.
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Pembrolizumab can affect the immune system. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
MIV-818 is a new drug. So there may be side effects we don’t know about yet.
A very few people have had MIV-818. Some of the side effects reported included:
We have information about and the side effects of:
Your doctor will talk to you about the treatments and their side effects before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Ruth Plummer
Medivir
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.