
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at a drug called INCB106385 by itself or with another drug called retifanlimab (INCMGA00012) for some solid cancers. It is open to people with cancer that has spread to another part of the body or the nearby tissue (advanced cancer).
A is any cancer apart from blood cancers such as leukaemia and lymphoma.
INCB106385 is an called an immunosuppressive metabolite. It works by blocking a substance called adenosine. Adenosine is responsible for suppressing the body’s immune response. Blocking adenosine helps the
fight cancer.
This is the first time that INCB106385 has been used in cancer patients. But it has been tested in healthy volunteers. Researchers need to find the best dose of INCB106385 for people with cancer to take. The best dose is the dose that helps the most and has the fewest side effects.
Retifanlimab is an immunotherapy called a checkpoint inhibitor. It works by blocking a protein called PD-1. Blocking PD-1 can help the immune system fight cancer.
The researchers know the best dose of retifanlimab to give. This is because a small number of cancer patients have had it.
In this study the team want to know what the best dose of :
So in this study some people have INCB106385 by itself and some have it in combination with retifanlimab.
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.
There are 2 parts to this study. The 2nd part is not open to people with some of the cancer types listed below. Your doctor will know which ones these are.
Who can take part
You may be able to join this study if you have one of the following:
Some of the above cancers must be a carcinoma. Your doctor will know which ones they are and if your cancer is a squamous cell carcinoma.
And 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 a phase 1 study. It is in 2 parts
The team needs a total of up to 306 people to take part:
In both parts some people have INCB106385 by itself. And some people have INCB160385 and retifanlimab.
In part 1 the team wants to find the best dose of INCB106385 to have by itself. They also want to find the best dose of INCB106385 when given together with retifanlimab. The best dose is the dose that helps the most and has the fewest side effects.
To find the best dose the first few people have a small dose. If they don’t have any problems then the next few have a higher dose. And so on until the team finds the best dose to give.
Part 2 starts when the team has found the best dose of INCB106385 to have by itself and the best dose of INCB106385 to have with retifanlimab.
What dose you have and whether you have INCB106385 by itself or with retifanlimab depends on when you join the study. Your doctor will tell you about this when you join the study.
INBC106385 is a tablet. You take it with a glass of water. Your doctor will tell you how many to take and when.
Some days you have a blood sample taken at the hospital before you take your dose of INCB106385. On these days you must not eat or drink for at least 2 hours before your visit to hospital. You then take INCB106385 after the blood sample collection and may have more blood taken afterwards. Your doctor will tell you beforehand when these days are.
You have retifanlimab as a drip into a vein. You have it every 4 weeks at the hospital.
You can have treatment for a maximum of 2 years as long as it is helping and the side effects aren’t too bad.
Samples for research
You have a sample of cancer tissue () taken before you start treatment and then during week 5 or week 6 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 when and 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 are:
You see the doctor at regular times during treatment. This is to see how you are, for blood tests and to ask about side effects.
You have a scan every 8 weeks during treatment. After a year this might be every 12 weeks. Your doctor will talk to you about this after a year of treatment.
You see the doctor when you stop treatment. This is to see how you are.
You then see the doctor a month and again 3 months later. This is to see how you are and 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.
INCB106385 and retifanlimab are immunotherapies. They 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. |
INCB106385 and retifanlimab are new drugs. The combination of these 2 drugs is also new. There might be side effects we don’t know about yet.
INCB106385 has been used in healthy people before. In a completed study of different doses of INCB106385 in healthy volunteers. The side effects that occurred most frequently included:
Since the start of the study a small number of people have had the combination of INCB106385 and retifanlimab. The side effects that have been reported are:
A small number of people have had INCB106385 either by itself or in combination with another drug. Side effects reported by at least 2 people are:
Based on animal studies the following side effects of INCB106385 may be possible in humans. They include:
The most common side effects of retifanlimab are:
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 Rebecca Kristeleit
Incyte Corporation
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”