Phase 3 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 cancer of the colon or upper part of the rectum, confirmed through a tissue sample (biopsy).
• People whose tumor has been tested and found to have a normal DNA repair system, described as "pMMR" or "microsatellite stable (MSS)", confirmed through laboratory testing of the tumor tissue.
• People whose cancer has been staged as a locally advanced tumor (described as cT4NxM0), meaning it has grown through the bowel wall but has not spread to distant parts of the body, and where the lower edge of the tumor sits above a specific internal boundary called the peritoneal reflection (confirm with trial site).
• People who have undergone a specific set of scans and examinations, including contrast CT scans of the chest, abdomen and pelvis, a physical rectal examination, and a high-resolution MRI scan, to confirm the cancer stage.
• People whose bowel is not blocked, or whose blockage has already been managed with a temporary stoma (a surgical opening to redirect the bowel).
• People who have not had any previous surgery on the colon or rectum.
• People who have not previously received chemotherapy or radiotherapy.
• People who have not previously been treated with biological medicines such as monoclonal antibodies, immunotherapy drugs, or experimental treatments.
• People who have signed a consent form agreeing to take part in the trial.

Who may not be able to join:

• People with certain heart conditions, including irregular heartbeat requiring specific medications, symptomatic coronary artery disease, a heart attack within the past 6 months, or significant heart failure.
• People with severe high blood pressure that is not adequately controlled with medication.
• People with a history of HIV infection, or currently active Hepatitis B or C with a high level of virus detected in the blood.
• People who currently have active tuberculosis (TB), are currently being treated for TB, or who received TB treatment within the past year.
• People with other serious active infections, as assessed by standard medical criteria.
• People whose cancer has spread to areas outside the pelvis (distant metastasis).
• People with significant blood disorders or serious problems with organ function.
• People who have previously had radiotherapy to the pelvis or abdomen.
• People with more than one colorectal cancer or more than one type of primary cancer at the same time.
• People with epilepsy that requires ongoing treatment such as steroids or anti-epileptic medication.
• People who have had another type of cancer diagnosed within the past 5 years.
• People with a history of drug misuse, or medical, psychological, or social circumstances that could affect their ability to participate or affect how results are assessed.
• People with an active autoimmune disease or a history of autoimmune conditions, including (but not limited to) certain lung, eye, bowel, liver, kidney, thyroid, or immune-related conditions, or asthma requiring certain inhalers.
• People who have received a live vaccine within the 4 weeks before joining the trial.
• People who have been using immunosuppressant medications or steroid medications at higher doses for an extended period.
• People with a known or suspected allergy to any of the medications used in the trial.
• People with any unstable health condition that could affect their safety or ability to follow the trial requirements.
• Women who are pregnant, breastfeeding, or of childbearing age and not using effective contraception.
• People who are not willing to sign a consent form to participate.

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