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 colon or rectal cancer (confirmed by tissue testing) that has a specific genetic feature called MMR deficiency or MSI-high, detected through laboratory testing.
• People who are in good general health (able to carry out normal daily activities with little or no limitation) and whose cancer is planned to be removed with surgery aiming for a cure, in line with national guidelines, and who are also considered suitable for chemotherapy after surgery.
• People with rectal cancer where the treating team has determined that radiation therapy before surgery is not needed to fully remove the tumour.
• People who had a bowel blockage caused by the tumour, provided the blockage has been successfully relieved by a stoma or stent and health has returned to a level that meets the other criteria.
• People whose blood cell counts meet the required levels — specifically, white blood cells, neutrophils, platelets, and haemoglobin all above certain thresholds (confirm exact values with trial site).
• People whose kidneys are working well enough, measured by a kidney function calculation above a set level.
• People whose liver is functioning adequately, based on specific blood test results being within acceptable ranges.
• People whose blood clotting measures are within acceptable ranges, or, if taking blood thinners, whose levels are within the intended treatment range.
• People aged 18 years or older.
• People who are willing and able to give written consent to participate.
• Women who could become pregnant must be willing to use highly effective contraception throughout the trial treatment and for 120 days after the last dose of the trial drug pembrolizumab.

Who may not be able to join:

• People for whom the treating medical team has recommended radiotherapy.
• People with clear evidence that the cancer has spread to distant parts of the body or to the lining of the abdomen.
• People who have previously been treated with certain immune-based cancer therapies, including drugs that target PD-1, PD-L1, PD-L2, or similar immune checkpoint pathways (such as CTLA-4 targeting drugs).
• People who have received any systemic cancer treatment or experimental therapy within 4 weeks before registering for the trial, or who have not yet recovered from side effects of previous treatments.
• People who have received a live or live-weakened vaccine within 30 days before registering (standard flu vaccines without live virus are allowed).
• People who have taken part in another clinical trial using an experimental treatment within 4 weeks before registering.
• People who have a condition affecting the immune system, or who are taking steroid medication at doses above a certain level, or other immune-suppressing medications within 7 days before starting trial treatment.
• People with another current or previous cancer that could affect the ability to assess the trial's results.
• People with active cancer that has spread to the brain or the lining around the brain.
• People who have had a severe allergic reaction to the trial drug pembrolizumab or any of its ingredients.
• People who have previously had a severe or life-threatening skin reaction to an immune-stimulating cancer drug.
• People with an active autoimmune disease that has needed medical treatment within the past 2 years (note: hormone or natural replacement therapies such as thyroid medication or insulin are generally permitted — confirm with trial site).
• People with a history of serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition.
• People with an active infection that requires treatment with medicines given throughout the body (such as intravenous or oral antibiotics).
• People with a known history of HIV infection.
• People with active hepatitis B or active hepatitis C infection (though people with previously treated and controlled hepatitis B or C may be eligible under certain conditions — confirm with trial site).
• People with a known history of active tuberculosis (TB).
• People who have received an organ or tissue transplant from another person.
• People who have peritonitis (infection or inflammation in the abdomen) caused by the tumour breaking through the bowel wall.
• People who have a bowel blockage caused by the tumour that has not yet been relieved by a stoma or stent.
• People with any other medical condition, ongoing therapy, or laboratory result that the treating doctor believes could affect the trial results or make participation unsafe.
• People with a known psychiatric condition or substance use disorder that could interfere with their ability to participate fully in the trial.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 120 days after the last dose of pembrolizumab.

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