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

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