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:

• Adults aged 18 or older, of any gender
• People who have been diagnosed with colorectal cancer that came back within 1 year after surgery (classified as stage IV), where the cancer has spread to other parts of the body that cannot be surgically removed, or where the person has chosen not to have surgery to remove those areas
• People who have already completed standard post-surgery chemotherapy using one of two specific regimens (known as XELOX or FOLFOX)
• People whose tumor tissue has been tested and shows a specific molecular profile — described as pMMR, MSS, or MSI-L — meaning the cancer does not have a feature called "mismatch repair deficiency"
• People who have at least one tumour that can be measured on a scan, according to standard medical criteria (called RECIST 1.1)
• People who are generally well enough to carry out daily activities with little or no difficulty (rated 0 or 1 on a standard scale called ECOG)
• People with a life expectancy of at least 3 months
• People whose blood, liver, kidney, thyroid, and clotting function all fall within acceptable ranges as measured by blood tests (confirm specific values with trial site)
• Women who could become pregnant must have a negative pregnancy test before joining
• People who are willing and able to use adequate contraception throughout the study and for 12 months after the last treatment dose (applies to women who could become pregnant and fertile men)
• People who have read, understood, and signed a consent form agreeing to take part
• People who are willing and able to attend scheduled visits and follow all study procedures

Who may not be able to join:

• People whose bowel tumour has been identified as a different type, such as a gastrointestinal stromal tumour
• People whose tumour has not been tested for a genetic feature called RAS mutation status
• People whose tumour testing shows a profile described as dMMR or MSI-H, meaning the cancer has a feature called "mismatch repair deficiency"
• People whose cancer spread (metastases) could be surgically removed, or who wish to have that surgery
• People with uncontrolled active bleeding from the original tumour, or a bowel blockage
• People for whom immune checkpoint inhibitor therapy (a type of cancer treatment used in this trial) is medically unsuitable
• People with a known allergy or sensitivity to the study drugs or their ingredients
• People with a current or past diagnosis of another cancer, with the exception of certain previously treated skin cancers, cervical carcinoma in situ, or papillary thyroid carcinoma
• People with an active autoimmune disease, or a history of certain autoimmune conditions — though some exceptions may apply, such as stable thyroid conditions managed with hormone replacement, type 1 diabetes managed with stable insulin doses, vitiligo, or childhood allergies that have fully resolved (confirm with trial site)
• People with a history of immune system deficiency, HIV, other immune conditions present from birth or developed over time, or who have had an organ transplant or bone marrow transplant
• People with a history of interstitial lung disease or non-infectious lung inflammation
• People with active tuberculosis, a recent history of tuberculosis within the past year, or a past tuberculosis infection that was not adequately treated
• People with active hepatitis B or hepatitis C at levels above specified thresholds (confirm specific values with trial site)
• People with severe heart, lung, kidney, or liver problems
• People with high blood pressure that cannot be adequately controlled with medication (systolic 140 mmHg or higher, or diastolic 90 mmHg or higher)
• People with a history of substance abuse, alcohol dependency, or drug addiction
• People with serious medical, psychiatric, or social circumstances that, in the opinion of the trial doctors, could affect safety or ability to follow the study requirements

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