Phase 2 Colorectal Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who are willing and able to sign a written consent form agreeing to take part.
• People aged 18 to 75 years old, of any gender.
• People who are generally fit and able to carry out everyday activities, as measured by a standard health performance score of 0 or 1 (confirm with trial site).
• People whose doctors estimate they are likely to live for at least 3 more months.
• People who have been diagnosed with a type of bowel cancer (colorectal adenocarcinoma) that has spread to other parts of the body, confirmed by laboratory testing of tissue or cells.
• People whose bowel cancer has been tested and found to have a specific genetic profile called MSI-L or MSS (confirm with trial site what this means for individual cases).
• People whose cancer has spread in a way that cannot be removed by surgery with the aim of a cure.
• People who have received one previous round of treatment for their metastatic bowel cancer, specifically a chemotherapy regimen containing oxaliplatin (such as FOLFOX or CAPOX), and no other systemic cancer treatments for the metastatic disease.
• People who have at least one tumour that can be measured on a scan, according to standard imaging guidelines.
• People who are able to provide 15 tissue samples from their tumour (either recently stored or freshly collected).
• People whose blood, kidney, liver, and clotting function results meet specific minimum levels set by the trial (confirm exact values with the trial site).

Who may not be able to join:

• People whose cancer has a specific genetic profile called MSI-H or dMMR.
• People whose cancer has a specific gene change called a BRAF mutation.
• People who have had another type of cancer within the past 3 years, unless it was a fully treated, localised cancer such as certain skin cancers, early-stage bladder cancer, or cervical carcinoma in situ.
• People who are currently enrolled in another clinical trial that involves an active treatment (observational studies or follow-up phases of previous trials may be acceptable — confirm with trial site).
• People who have previously received any form of cancer immunotherapy, including checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 drugs), immune-activating drugs, or immune cell therapies.
• People who have an active autoimmune disease that has required ongoing medical treatment within the past two years (note: hormone replacement therapies for certain conditions are not considered to be in this category — confirm with trial site).
• People who have a history of inflammatory bowel disease such as Crohn's disease, ulcerative colitis, or long-term chronic diarrhoea.
• People with a history of immune system deficiency, a positive HIV test, or those currently taking long-term steroid or immune-suppressing medications.
• People who have active tuberculosis (TB) or active syphilis infection.
• People who have previously had an organ transplant or a stem cell transplant from a donor.
• People who have had, or currently have, a non-infectious lung condition or interstitial lung disease that required treatment with steroid medications.
• People who had a serious infection requiring hospitalisation within the 4 weeks before starting treatment, or who have been taking systemic antibiotics or anti-infective medications within 2 weeks before starting treatment (ongoing antiviral treatment for hepatitis B or C is not included in this restriction).
• People with active hepatitis B, where the virus is detectable above a certain level in the blood (people with stable, treated hepatitis B at low viral levels may still be considered — confirm with trial site).
• People with active hepatitis C, where the virus is detectable in the blood.
• People who have had major surgery or a serious physical injury within the 30 days before starting treatment, or who have major surgery planned within 30 days after starting treatment; or those who have had minor surgery within 3 days before starting treatment (minor procedures such as placing an intravenous line are generally not included — confirm with trial site).

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