
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This trial is looking at adding retifanlimab to chemotherapy to improve treatment for people with anal cancer.
It is for people:
You might have a combination of carboplatin and paclitaxel chemotherapy to treat anal cancer that has come back or spread. This is a .
Doctors are looking at ways to improve treatment. In this trial they are looking at adding a drug called retifanlimab to chemotherapy. Retifanlimab is a type of immunotherapy drug called a monoclonal antibody. It stimulates the body's to fight cancer cells.
In this trial some people have carboplatin, paclitaxel and retifanlimab. And some people have carboplatin, paclitaxel and a dummy drug ().
The main aims of the trial are to find out:
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial 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 trial if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This phase 3 trial is taking place worldwide. The team need to find 300 people to take part including 39 from the UK.
It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. Nor will you know which group you are in. Your doctor can find this out if necessary.
There are 2 treatment groups. You have 1 of the following:
You have treatment in cycles. Each 4 week period is a cycle of treatment. The first day of each cycle is called day 1.
In each cycle you have treatment as follows:
You have all your treatment as a drip into a vein. Retifanlimab or the dummy drug takes up to 45 minutes to have each time. Paclitaxel takes up to 90 minutes and carboplatin takes up to an hour each time. You might be at the hospital for longer than this.
You have treatment for about a year as long as it is working and the side effects aren’t too bad.
If your cancer gets worse, the team check to see if you had retifanlimab or the dummy drug. People who had the dummy drug might then be able to go on and have retifanlimab on its own. You have this once a month for about a year.
The team will talk to you about other treatment options if you have already had retifanlimab.
Samples for research
The trial team ask you to give some extra blood samples. Where possible you have these at the same time as your routine blood tests.
They will also ask to look at samples from a previous cancer tissue sample. They might ask you to give a new sample if there isn’t one available.
The researchers plan to use the samples to:
Quality of life
The trial team ask you to fill out a questionnaire:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor and have tests before you can take part. These include:
You may also need to provide a poo (stool) sample.
You have all your treatment at the hospital on the day care ward.
You see the doctor for a check up and blood tests:
When you finish treatment you see the team a month later for a check up.
Scans
You have a CT scan every 8 weeks. You stop having the scans as part of the trial if your cancer gets worse.
Follow up
When you finish treatment the trial team follow you up every 3 months. This will be either at a routine hospital appointment or the team call you to see how you are getting on.
The trial 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.
Retifanlimab 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. |
The most common side effects of retifanlimab are:
The trial team will talk to you about all the side effects of treatment before you join the trial.
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Sheela Rao
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.”