A trial looking at tolinapant and chemoradiotherapy for cervical cancer that has spread (CRAIN)

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 adenocarcinoma  or squamous cell cancer  of the cervix. Your doctor will know this.
• have cervical cancer that is stage 1B2 or 1B3, it is stage 2 or it is stage 3A, stage 3B or stage 3C1. This includes cancer that measures at least 2cm across. The cancer may have spread into tissues around the cervix, grown into the pelvis or be blocking the tubes that drain the kidneys (the ureters). It may also have spread to lymph nodes in the pelvis but not into the lymph nodes in the tummy (abdomen). 
• are suitable to have radiotherapy and cisplatin chemotherapy 
• are fit and active 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 if there is any chance you could become pregnant  
• are at least 16 years old

Who can’t take part

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

You have had previous treatment for cancer that included:

• radiotherapy to the pelvis in the past 
• recent radiotherapy or chemotherapy 
• recent cancer treatment directly to the skin
• recent treatment with drugs called monoclonal antibodies , small molecule drugs or targeted cancer drugs
• a type of immunotherapy called CAR T-cell therapy in the last 6 weeks. Your cancer must have got worse after this to take part in this trial. 

As well as the above you cannot join if any of the following apply. You:

• have cancer that has spread to a distant part of the body 
• have had an experimental treatment as part of a trial within the last 30 days 
• have any other cancer that needs treatment 

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

• have severe liver problems
• have HIV or an active hepatitis B or C infection 
• have had a heart attack or another significant heart problem  that needed treatment in the last 6 months 
• have a condition that needs steroid treatment unless you are having a low dose. Or you have another treatment that damps down your immune system  within 14 days of having trial treatment.
• have had major surgery within 30 days of joining the trial 
• are having medication that affects CYP enzymes 
• have an active COVID-19 infection when you consent to join the trial 
• have had major surgery in the last 30 days

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

• are allergic to tolinapant, anything it contains or any of the other treatments in the trial 
• have had a live vaccination  within 30 days of joining the trial. You can have the approved COVID-19 vaccines as they aren’t live.
• are pregnant or breastfeeding