A trial of RO7121661, RO7247669 or nivolumab for cancer of the food pipe (TALIOS)

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 squamous cell cancer  of the oesophagus that has spread into surrounding tissues or to another part of the body (advanced or metastatic cancer)
• can’t have surgery to remove the cancer and you have had one course of chemotherapy  that stopped working after 3 cycles. The chemotherapy must have included a drug such as 5FU or capecitabine and a platinum drug . Or the chemotherapy you had must have included a taxane  such as paclitaxel and a platinum drug.
• have cancer that your doctor can measure on the scan 
• have a sample of cancer tissue (biopsy ) available for the trial team to do some tests on
• are fit and can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
• have satisfactory blood test results  
• are willing to use reliable contraception during treatment and for a time after if there is any chance you or your partner could become pregnant
• 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 already had immunotherapy  or a similar drug 
• have had CAR T-cell therapy in the past or a similar treatment 
• have had radiotherapy within 28 days of starting trial treatment. You may be able to take part if you are having treatment for cancer symptoms.
• have cancer that has spread to the brain or spinal cord unless it isn’t causing symptoms, has been treated and is stable
• have cancer that is pressing on or near the spinal cord (spinal cord compression)  that hasn’t been treated and isn’t stable within 2 weeks of being put in a treatment group
• have or have had cancer cells that have spread to the thin layers of tissue that cover the brain and spinal cord
• have pain from cancer that isn’t well controlled 
• have had an experimental treatment within 28 days of being put into a treatment group or the treatment hasn’t cleared your body yet 
• have another cancer. This is apart from CIS  of the cervix, ductal carcinoma of the breast , non melanoma skin cancer,  very early melanoma skin cancer, or early prostate cancer that has been successfully treated. Or you may be able to take part if you had another early cancer and there have been no signs of it for at least 2 years. 

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

• have had a significant heart problem  such as a heart attack within 6 months of being put into a treatment group
• have had a stroke  or mini stroke within 6 months of being put into a treatment group
• have liver problems
• are poorly nourished (have malnutrition) 
• have a blockage in your food pipe and you can’t have treatment to fix this
• have a high risk of bleeding or a fistula  caused by areas of cancer in the food pipe
• have uncontrolled fits (seizures) or you have had a serious infection in your brain in the last year 
• have had treatment that dampens down the immune system  within 28 days of being put into a treatment group. This doesn’t include having low dose steroids. 
• have had major surgery or a serious injury within a month of being put into a treatment group 
• have areas of fluid on the lung or tummy that need to be drained often. This doesn’t apply if you have a long term drain in your lung. 
• have an autoimmune disease  that needs treatment. This is apart from certain ones which your doctor will know about. 
• have scarring in the lungs (fibrosis ) or other parts of the body 
• have diabetes  
• have an active hepatitis B or hepatitis C infection, HIV or an infection that needs treatment within 14 days of starting trial treatment 
• have moderate to severe side effects from past treatments that aren’t getting better. This doesn’t include hair loss, white patches on your skin, taking medication to replace hormones  or mild numbness or tingling in your hands and feet. 
• have any other medical condition or mental health problem that the trial team think would affect you taking part

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

• are allergic to RO7121661, RO7247669, nivolumab or anything they contain 
• have had a live vaccine  within 30 days of the start of treatment or might need to have one during the trial.  Please note that the current approved COVID-19 vaccines aren’t live. 
• are pregnant or breastfeeding