
"I am glad that taking part in a trial might help others on their own cancer journey.”
This study is looking at new drug called alomfilimab (KY1044). It is looking at giving alomfilimab by itself and in combination with atezolizumab for of the head and neck.
It is open to people with a head and neck cancer that is a type.
Atezolizumab is an . It works by blocking a protein that stops the
from working properly and attacking cancer cells. Blocking this protein helps the immune system to find and kill the cancer cells. Doctors already use atezolizumab to treat many different types of cancer.
Alomfilimab is also an immunotherapy. It works in a similar way to atezolizumab but alomfilimab blocks a different protein.
Researchers think that alomfilimab by itself or with atezolizumab might help people with cancer that has spread.
The team have found the best dose of alomfilimab to give by itself and also in combination with atezolizumab. They now want to find out how well these treatments work.
In this study some people will have alomfilimab. And some people will have alomfilimab with atezolizumab.
The aims of this study are to find out:
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:
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
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. The study team need 412 people worldwide to join.
There are 2 groups in this study those who have:
Your doctor will tell you which group you are in.
You have alomfilimab and atezolizumab as a drip into a vein. You have them every 3 weeks. Each 3 week period is a .
You continue treatment as long as it is helping and the side effects aren’t too bad.
Samples for research
You give some blood samples and tissue samples () during the study. Where possible the team take these when you have them taken as part of your routine care.
Researchers use these samples to look for substances in the blood and tissue () that might tell them:
You don’t have to agree to do this.
You see the doctor to have tests before you take part. These tests include:
You see the doctor for blood tests and to see how you are:
You have a scan every 8 weeks for 16 weeks and then every 3 months for 4 years. This is if you are still having treatment or until your cancer starts to grow again.
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.
Alomfilimab and atezolizumab can affect the immune system. They 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. |
Alomfilimab is a new drug and there might be side effects we don’t know about yet. The most common side effects we do know about are:
Some people have had alomfilimab with atezolizumab. There might be side effects from this combination we don’t know about yet. The most common side effects we do know about are:
We have information about the side effects of atezolizumab.
Your doctor will talk to you about the possible side effects of the treatments 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 Fiona Thistlethwaite
Kymab, a Sanofi Company
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”