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 who have given written consent to participate.
• People with a confirmed diagnosis of bowel cancer (colon or rectal cancer) that cannot be removed by surgery and has spread to other parts of the body.
• People whose tumour has been tested and found to be a specific type (non-MSI-H/non-dMMR), meaning it does not have a particular genetic feature linked to some immunotherapy treatments (confirm with trial site).
• People who have already received at least one course of chemotherapy for their bowel cancer after it spread or came back.
• People who are reasonably active and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 or 1 — confirm with trial site).
• People whose cancer can be measured on scans according to a standard method used in clinical trials.
• People who are able to provide a tumour tissue sample (either stored from a previous biopsy or a new sample) during the screening period.
• People whose kidneys, liver, and blood counts are working at adequate levels as shown by recent blood tests.
• People who have not received blood transfusions, growth factor injections, or albumin infusions in the 14 days before starting the study treatment.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures.
• People of childbearing potential who agree to use a highly effective form of contraception from the start of treatment (or 14 days before for oral contraception) and for at least 3 months after the last dose, and who agree not to donate sperm or eggs during this period.

Who may not be able to join:

• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People enrolled in a specific part of the trial (Part 2, Cohort A) who have active cancer spread in the liver visible on CT or MRI scans.
• People who have recently taken certain types of medications too close to the start of the trial, including targeted cancer drugs (within 2 weeks), other systemic cancer treatments (within 3 weeks), another experimental drug or active clinical trial (within 30 days), or certain medications that affect how the body processes drugs (within a timeframe based on that drug's half-life — confirm with trial site).
• People who have previously received certain immunotherapy treatments, including checkpoint inhibitors such as PD-1, PD-L1, or CTLA-4 therapies.
• People who have had a partial or complete bowel blockage in the past 3 months, or who have current symptoms or scan findings suggesting a blockage may be developing.
• People with fluid build-up in the abdomen that has not responded to treatment (refractory ascites).
• People who currently have or have previously had serious lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment.
• People who have been taking corticosteroids at doses above a certain level (more than 10 mg of prednisone or equivalent per day) or other immune-suppressing medications within the past 28 days.
• People with an active autoimmune disease that has needed systemic treatment within the past 2 years.
• People with a condition affecting the adrenal or pituitary glands.
• People with a history of serious heart conditions, including heart failure, unstable chest pain, poorly controlled high blood pressure, significant valve disease, dangerous irregular heart rhythms, heart attack, stroke, or mini-stroke within the past 6 months.
• People who have had an organ transplant, stem cell transplant, or bone marrow transplant from a donor.
• People who have had a recent COVID-19 (SARS-CoV-2) infection — within 10 days for mild or no symptoms, or within 20 days for a severe or critical illness — before starting the study treatment.
• People who need to take strong medications that significantly affect how the body breaks down certain drugs (strong CYP3A4 inducers or inhibitors — confirm with trial site).
• People with a digestive condition, such as malabsorption, that could affect how the body absorbs the study medication.
• People with elevated levels of a heart protein called Troponin I on blood tests.
• People with high blood pressure that is not well controlled.
• People with an abnormal heart electrical reading (QTcF of 470 ms or more on an ECG — confirm with trial site).
• People whose heart pumping function is below a certain level (left ventricular ejection fraction under 50% on a heart scan).
• People with active, uncontrolled cancer that has spread to the brain or spine and is currently requiring steroids or anti-seizure medications within the past 2 months. (People with previously treated and stable brain metastases may still be considered — confirm with trial site.)
• People with cancer spread to the membranes surrounding the brain or spinal cord (leptomeningeal disease).
• People with spinal cord compression that has not been fully treated with surgery or radiation.
• People with a serious bleeding condition or who are taking blood-thinning medication that cannot be quickly reversed.
• People who have or have recently been treated for another cancer in the past 3 years, unless it was a type of easily curable skin cancer, early-stage bladder cancer, or certain non-invasive cancers (confirm with trial site).
• People with a history of uncontrolled seizures, significant nervous system disorders, substance use disorder, or a serious psychiatric condition that could interfere with taking part in the trial.
• People with an active infection requiring antibiotic or antiviral treatment at the time of starting the study.
• People who test positive for HIV, active hepatitis B, or active hepatitis C with a detectable viral load.
• People who are pregnant or breastfeeding, or who plan to breastfeed within 3 months of the last dose of study treatment.
• People who have had major surgery within the 28 days before starting the study, or minor surgery (other than a biopsy) within 7 days before starting, unless they have fully recovered.
• People with any other significant illness, medical condition, or abnormal test result that, in the opinion of the treating doctor, could affect safety or the reliability of the trial results.
• People who would need to take medications that are prohibited during the trial.

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