Phase 2 Colorectal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older
• You have been diagnosed with colorectal cancer (bowel cancer that has spread), confirmed by a tissue or cell sample
• Your cancer has spread to other parts of the body (stage 4), and you have either tried all standard treatments available, standard treatments are no longer considered right for you, side effects from past treatment have limited your options, or you are on a planned break from treatment
• Your cancer can be measured on scans, following standard medical guidelines
• You are expected to live for at least 6 months at the time of joining, and at least 3 months by the time the personalised treatment is ready
• You are generally well and able to carry out daily activities with little or no limitation (confirm with trial site)
• Your blood counts, liver, and kidney function are within acceptable levels as measured by blood tests
• You are willing and able to use highly effective contraception during the trial and for 6 months after receiving the treatment, if you or your partner could become pregnant
• You are able to have surgery or a biopsy to collect tumour tissue and nearby lymph nodes for use in making your personalised treatment
• The area where lymph nodes will be removed has not previously been treated with radiotherapy

Who may not be able to join:

• You have had a serious heart event (such as a heart attack, stroke, bypass surgery, or a mini-stroke) within the last 4 months (or 6 months at the time of receiving treatment) — note that well-controlled atrial fibrillation is not automatically excluded
• You have severe heart failure that significantly limits your daily activity
• You have significantly reduced lung function, as measured by a breathing test (spirometry), with results below a certain threshold — this may also apply if you were hospitalised with COVID-19 in the last 6 months
• You have any serious ongoing medical condition that could put you at increased risk or make the trial results harder to interpret (confirm with trial site)
• You have an immune system disorder (other than HIV, which is listed separately) that could affect your safety or the effectiveness of the treatment — for example, a transplant history or a condition affecting your immune system
• You have an autoimmune condition (where the immune system attacks the body) that could affect your safety or treatment outcome (confirm with trial site)
• Your cancer has spread to the lining around the brain or spinal cord — though if you have had previously treated brain tumours with no sign of growth for at least 8 weeks, are symptom-free, and are not taking steroids for brain symptoms, you may still be considered
• You are currently taking medications that suppress the immune system — these must be stopped at least 2 weeks before surgery or treatment (steroid inhalers or creams, or steroids used as hormone replacement, may be acceptable)
• You have previously had a severe (grade 3 or higher) immune-related side effect from immunotherapy, unless it fully resolved and did not come back when the therapy was tried again
• You have an active or ongoing infection with hepatitis B, hepatitis C, or syphilis
• You have HIV infection
• You are currently pregnant or breastfeeding
• The trial team feels you are unlikely to be able to follow the trial schedule and requirements
• You do not have at least 3 enlarged lymph nodes visible on scans that can be surgically removed (for patients needing surgery to collect starting material)
• Your original bowel cancer tumour has already been surgically removed, as this would make the required surgery too high-risk (confirm with trial site)
• You are not well enough to undergo the planned surgery, including being unable to have general anaesthetic
• It has been less than 4 weeks since you stopped your last cancer treatment
• It has been less than 2 weeks since you finished radiotherapy
• It has been less than 4 weeks since major surgery, or less than 3 weeks since minor surgery
• You are currently taking part in another cancer therapy clinical trial, or have done so in the past 4 weeks
• You have received a live vaccine within the past 4 weeks

Important: Always verify eligibility with the trial site directly before applying.