
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This study is looking at a drug called INCB099318 for . A solid cancer is any cancer apart from blood cancers such as leukaemia and lymphoma.
The study is open to people who:
INCB099318 is a called an immunotherapy. It works by blocking a protein called PD-L1. Blocking PD-L1 can help the
fight cancer.
To find out if INCB099318 can help fight cancer researchers need to do a large . Before doing this they need to find out what is the best dose for people to take. The best dose is one that helps the most and has the fewest side effects.
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. You:
There are other parts to this study you might be able to join. Your doctor will know if you can.
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
You cannot join part 1 of the study if you have cancer spread to a fifth (20%) or more of your liver. Your doctor can tell you more about this.
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 a phase 1 study. The team plan to have up to 180 people take part with about 20 people in the UK.
The study is in 2 parts.
In part 1 the team want to find the best dose of INCB099318. This is one that helps the most and has the fewest side effects.
The first few people in this part take a small dose of INCB099318. If that goes well then the next people take a higher dose. And so on until the team find the best dose of INCB099318.
Part 2 starts after the team find the best dose of INCB099318 to take.
INCB099318 is a tablet. You take it with a glass of water.
What dose you have and how often you have it depends on when you join the study. Your doctor will tell what dose to take and how often you take it.
You can have INCB099318 for up to 2 years if it is helping and the side effects aren’t too bad.
Samples for research
You have a sample of tissue (biopsy) taken before you start treatment and then between week 2 and week 3 of treatment. You must agree to these to take part.
The team might ask to take another biopsy during treatment. This biopsy is optional. You don’t have to agree to it.
You give several blood samples during the study. Your doctor will tell you more about how often these are.
Researchers use the tissue and blood samples to find out:
You see the doctor to have tests before taking part. These tests include:
During treatment you see the doctor regularly to see if you have any side effects and for:
You have a CT scan or MRI scan every 8 weeks for a year and then every 3 months while taking INCB099318.
If you stop taking INCB099318 and your cancer has not got worse you have the scan:
After a year you then have the scan every 3 months.
About a month after stopping INCB099318 you see the doctor to see if you have any side effects and for:
You then see the doctor about 3 months later to see if you have any side effects.
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.
INCB099318 can affect the immune system. It may cause inflammation or immune reactions in different parts of the body. These reactions are usually well tolerated but 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. |
INCB099318 is a new drug and there may be side effects we don’t know about yet. The side effects we do know of include:
Your doctor will talk to about the possible side effects before you agree to take part in the study.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr David Pinato
Incyte Corporation
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”