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 aged 18 or older at the time of signing the consent form
• People who are generally well enough to carry out daily activities with little or no limitation (based on a standard medical fitness scale called ECOG, with a score of 0 or 1)
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting treatment, and again within 7 days before the first dose
• Women who could become pregnant must be willing to use a highly effective form of birth control throughout the study and for at least 120 days after the last dose of the study drug — accepted methods include hormonal contraception that stops ovulation (such as patches, injections, or implants), an intrauterine device (IUD), an intrauterine hormone-releasing system, bilateral tubal occlusion, a vasectomised sole partner (confirmed by a doctor), or complete abstinence from sex if that is consistent with the person's usual lifestyle (note: oral contraceptive pills alone are not considered sufficient and must be used with a barrier method such as condoms)
• Men who are not sterile must also use a highly effective form of birth control during the study and for at least 120 days after the last dose of the study drug
• People whose blood tests show that their kidneys, liver, bone marrow, and blood clotting are working at acceptable levels (tested within 14 days before starting treatment)
• People who are willing and able to follow the study schedule and give their informed consent

For people joining Cohort 1 (metastatic colorectal cancer):

• A confirmed diagnosis of colorectal cancer (a specific type called adenocarcinoma), confirmed by tissue sample
• The cancer must have a specific genetic feature called dMMR, confirmed by laboratory testing
• The cancer must have spread to other parts of the body (metastatic disease) in a way that can be measured on scans, and surgery to cure the cancer is not considered a realistic option

For people joining Cohort 2 (localised rectal cancer):

• A confirmed diagnosis of rectal cancer (adenocarcinoma), confirmed by tissue sample
• The cancer must have the dMMR genetic feature, confirmed by laboratory testing
• The cancer must be at Stage II or III (based on standard staging guidelines), meaning it has not spread to distant parts of the body
• There must be no evidence that the cancer has spread beyond the local area

Who may not be able to join:

• People who currently have another active cancer
• People who have been diagnosed with an immune system deficiency, or who have received steroid tablets or other immune-suppressing medicines within 7 days before the first dose (some low-dose or topical steroid use may be permitted — confirm with trial site)
• People who have needed immune-suppressing medicines or corticosteroids at a dose higher than the equivalent of 10 mg of prednisone per day within 14 days before the first dose (certain low-dose, short-term, or topical steroid uses may be allowed — confirm with trial site)
• People with an active autoimmune disease that has required ongoing medical treatment within the past 2 years (well-controlled thyroid disease, diabetes, or skin conditions may be permitted — confirm with trial site)
• People with untreated, active Hepatitis B or Hepatitis C (people whose condition is well controlled with treatment may be permitted — confirm with trial site)
• People with untreated AIDS (people with HIV that is well controlled on antiviral medication may be permitted — confirm with trial site)
• People who have an active infection requiring antibiotic, antifungal, or antiviral tablets or drips within 14 days before the first dose
• People with a history of certain lung conditions, including interstitial lung disease, non-infectious lung inflammation, pulmonary fibrosis, or other uncontrolled lung diseases
• People who are currently receiving any other cancer treatment or experimental treatment
• People who have previously received a type of cancer treatment known as an immune checkpoint inhibitor
• People who previously had a serious (Grade 3 or higher) immune-related side effect from immunotherapy
• Women who are pregnant or breastfeeding, or anyone planning to conceive a child during the trial or within 120 days after the last dose
• People who have received a live vaccine within 30 days before the planned treatment start
• People who have had a major surgical procedure or serious physical injury within 28 days before joining the trial
• People with a known allergy to the study drug, tislelizumab
• People who have previously had an organ transplant or bone marrow/stem cell transplant from a donor
• People with certain heart or blood vessel conditions within the timeframes listed, including: chest pain from the heart within 28 days, a blood clot in the lungs within 28 days, a heart attack within 6 months, severe heart failure within 6 months, a serious heart rhythm problem within 6 months, a stroke within 6 months, high blood pressure that cannot be controlled with standard medicines within 28 days, or an episode of fainting or seizure within 28 days

For people in Cohort 1 only:

• People who have already received immunotherapy, chemotherapy, radiation, or surgery for metastatic colorectal cancer (treatment for an earlier, non-spread cancer may be allowed if it was completed at least 6 months before starting the trial — confirm with trial site)
• People with active cancer that has spread to the brain or the lining of the brain (people with previously treated, stable brain metastases confirmed by MRI at least 4 weeks after treatment may be permitted — confirm with trial site)

For people in Cohort 2 only:

• People who have already received immunotherapy, chemotherapy, radiation, or surgery for their localised rectal cancer
• People whose cancer has spread or come back

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