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:

• People who have been diagnosed with colorectal cancer that has spread to other parts of the body, confirmed by a tissue sample test.
• People who have already received, were unable to receive, or chose not to receive two standard treatment courses for their cancer (specific drug combinations including bevacizumab, regorafenib, trifluridine, and possibly EGFR-targeted therapy depending on cancer type). People whose cancer has a specific genetic feature (MSI-H/dMMR) must also have received one course of immunotherapy called a checkpoint inhibitor.
• People whose cancer came back within 6 months after completing standard post-surgery treatment, and who have not yet received treatment for the spread of the cancer. Those with the MSI-H/dMMR genetic feature must also have received one course of checkpoint inhibitor therapy.
• People aged 18 or older.
• People whose cancer can be measured using standard imaging criteria (confirm with trial site).
• People who are reasonably physically active and able to care for themselves, based on a standard medical scoring system (confirm with trial site).
• People whose blood, liver, and kidney function meet specific minimum levels as measured by blood tests (confirm with trial site).
• People who have recovered from most side effects of previous cancer treatments, with only mild or well-managed symptoms remaining.
• People who have had brain tumours treated and whose follow-up brain scans show no signs of the cancer growing back in the brain.
• People living with HIV, if they have been on appropriate HIV medication for at least 6 months, have a very low viral load, and their immune cell count meets the required level.
• People who have had Hepatitis C, if they have completed antiviral treatment and the virus is no longer detectable in their blood.
• People who are able to father children or become pregnant must be willing to use effective contraception from the start of the trial until 6 months after the last dose of the study treatment.
• People who are breastfeeding must be willing to stop breastfeeding from the start of treatment through to 6 months after treatment ends.
• People who have at least one tumour that can be safely accessed for a biopsy (a small tissue sample), and who are willing to have mandatory biopsies during the first phase of the trial. In the second phase, the treating doctor may waive this requirement if a biopsy is too difficult or risky to obtain.
• People who are able to understand and are willing to sign a written consent form.

Who may not be able to join:

• People who have received an experimental drug, chemotherapy, immunotherapy, or therapeutic radiation within 14 days before starting the trial treatment.
• People who have received radiation for pain relief within 7 days before starting the trial treatment.
• People with an active autoimmune disease that requires high-dose steroid or immune-suppressing medication to manage, with some exceptions for inhaled, topical, or short-course steroid treatments.
• People with a current or past serious lung condition called interstitial lung disease, or active non-infection-related lung inflammation. People with stable, symptom-free lung scarring from previous radiation are not excluded.
• People with active infections requiring antibiotic, antifungal, or antiviral medication within 8 days before starting treatment, unless the infection was mild and the person has clearly improved with treatment already started.
• People who have had an organ transplant, including bone marrow transplants.
• People who had a serious immune-related reaction to a checkpoint inhibitor in the past that led to the treatment being permanently stopped, or who needed steroid treatment for an immune reaction (except for hormone-related side effects that are now well controlled with replacement therapy).
• People who have had a serious allergic reaction to drugs with a similar makeup to the study drugs.
• People who have received a live vaccine within 28 days before starting treatment (examples include measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and typhoid vaccines; standard injected flu vaccines are generally allowed, but nasal spray flu vaccines are not).
• People with a history of Hepatitis B infection, unless they are on medication to keep the virus suppressed. People with blood test evidence of a past resolved Hepatitis B infection may still be eligible (confirm with trial site).
• People who are pregnant, confirmed by a pregnancy test at the screening stage.
• People with other serious, uncontrolled health conditions that would make it difficult to follow the trial requirements.

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