A trial of retifanlimab and chemotherapy for anal cancer (POD1UM-303/InterAACT 2)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Anal cancer

Secondary cancers

Status:

Closed

Phase:

Phase 2

This trial is looking at adding retifanlimab to chemotherapy to improve treatment for people with anal cancer.

It is for people:

who can’t have surgery to remove the cancer and
whose cancer has come back after previous treatment or it has spread elsewhere in the body

More about this trial

You might have a combination of carboplatin and paclitaxel chemotherapy to treat anal cancer that has come back or spread. This is a standard treatment Open a glossary item .

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 immune system Open a glossary item to fight cancer cells.

In this trial some people have carboplatin, paclitaxel and retifanlimab. And some people have carboplatin, paclitaxel and a dummy drug (placebo Open a glossary item ).

The main aims of the trial are to find out:

which treatment works best
more about the side effects
how treatment affects quality of life
what happens to retifanlimab in the body

Who can enter

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:

have anal cancer that has spread elsewhere in the body or has come back after treatment and you can’t have surgery to remove it
have already had treatment to the whole body (systemic treatment ). You can still take part if you had chemoradiotherapy before or after surgery that finished more than 6 months ago.
have a sample of cancer tissue available for the trial team to do some tests on or you are willing to give a new sample
have cancer that your doctor can measure on a scan
have satisfactory blood test results
are fit and active but might not be able to do heavy physical work (performance status 0 to 1)
are willing to use reliable contraception during the trial and for a period after if you or your partner could become pregnant
are willing not to donate sperm
are fully vaccinated against COVID-19 or you are willing to have the vaccine
are at least 18 years old

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

have cancer that has spread to the brain or the tissue that surrounds the brain (carcinomatous meningitis)
have already had retifanlimab or a similar drug in the past
have had recent radiotherapy with or without chemotherapy
have another cancer that is getting worse or needs treatment or you had another cancer within 3 years. You may take part if you had successfully treated basal cell skin cancer , squamous skin cell cancer , early bladder cancer, a pre cancerous condition of the prostate, CIS of the cervix. You may also be able to take part if you have an early cancer that has been treated and there have been no signs of it for more than a year.

Medical conditions
You cannot join this trial if any of these apply. You:

have had a heart attack in the last 6 months or a significant heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial.
have an active autoimmune condition that needs treatment apart from certain ones. You may be able to take part if you are having low dose treatment. Your doctor will know this.
have scarring on the lungs or active inflammation of the lungs (pneumonitis )
have had an organ transplant or a stem cell transplant with someone else’s cells
have an active hepatitis A, hepatitis B, hepatitis C or another active infection that needs treatment
have HIV unless you are having treatment and it is stable
have had a heart attack in the last 6 months or a significant heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial.
are taking a medication that you can’t have if you take part in the trial. Your doctor checks all your medications before you can join the trial
have tingling and numbness in your hands and feet (peripheral neuropathy ) unless it is mild
have any other medical condition that the trial team think could affect you taking part

Other
You cannot join this trial if any of these apply. You:

are allergic to a drug called paclitaxel, monoclonal antibodies or anything they contain
have had a live vaccine within 28 days of starting trial treatment
are pregnant or breastfeeding

Trial design

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:

carboplatin, paclitaxel and retifanlimab
carboplatin, paclitaxel and a dummy drug (placebo)

POD1UM-303/InterAACT 2 trial randomisation diagram

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:

retifanlimab or the dummy drug on day 1
carboplatin on day 1
paclitaxel on day 1, day 8 and day 15

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:

look at substances called biomarkers to help work out why treatment might work for some people and not for others
look at genes in your cancer cells to learn more about anal cancer
look for small bits of DNA that cancer can release into the blood
see what happens to retifanlimab in the body

Quality of life
The trial team ask you to fill out a questionnaire:

before you start treatment
at set times during treatment

The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor and have tests before you can take part. These include:

blood tests
urine test
a physical examination
heart trace (ECG )
CT scan or MRI scan

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:

on the days you have treatment for the first 6 months and then
once a month until you finish treatment

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.

Side effects

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: