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:

Cohorts A and B (older adults group):

• People aged 70 years or older
• People whose general health and ability to carry out daily activities falls within a certain range, as assessed using a standard medical scale (ECOG score of 0–2)
• People who have been confirmed through a tissue sample to have colorectal cancer that is localised or locally advanced, and has a specific genetic feature called mismatch repair deficiency (dMMR) or microsatellite instability (MSI-H)
• People who have not previously received any systemic cancer treatment (such as chemotherapy) or radiation therapy
• People who are willing to undergo regular internal camera examinations (endoscopies) and CT scans over 24 months
• People who agree to have a sample of tumour tissue taken
• People whose blood test results show that their organs (such as kidneys and liver) and bone marrow are functioning at a level that meets the study's requirements
• People whose heart pumping function (LVEF) has been measured at 45% or above using a heart scan, within the 6 months before starting the study drug
• Both women and men who are willing to use an acceptable form of contraception throughout the study
• People who are able to understand and are willing to sign a written consent form

Cohorts C and D (broader eligibility group):

• People aged 18 years or older
• People whose general health and ability to carry out daily activities falls within a certain range, as assessed using a standard medical scale (ECOG score of 0–3)
• People who have been confirmed through a tissue sample to have colorectal cancer that is localised or locally advanced, and has a specific genetic feature called mismatch repair deficiency (dMMR) or microsatellite instability (MSI-H)
• People who a surgeon has determined are not good candidates for surgery, or who are unwilling to undergo surgery
• People who have not previously received any systemic cancer treatment (such as chemotherapy) or radiation therapy
• People who are willing to undergo regular internal camera examinations (endoscopies) and CT scans over 24 months
• People who agree to have a sample of tumour tissue taken
• People whose blood test results show that their organs and bone marrow are functioning at a level that meets the study's requirements
• Both women and men who are willing to use an acceptable form of contraception throughout the study
• People who are able to understand and are willing to sign a written consent form

Who may not be able to join:

Cohorts A and B:

• People who have taken part in another clinical trial or used an experimental medical device within the 28 days before starting this study
• People who are expected to need any other cancer treatment during the study
• People who have had surgery within 28 days before starting the study drug, not counting minor procedures such as dental work or a small skin biopsy
• People who received certain types of immunotherapy drugs (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies) in the 5 years before their colorectal cancer diagnosis
• People who are currently taking long-term steroid medications on a regular basis
• People who have received a live vaccine within 30 days before starting the study drug
• People who have had a severe allergic reaction to any monoclonal antibody (a type of treatment made from immune cells)
• People with uncontrolled ongoing illnesses, including uncontrolled infections, serious heart conditions, cancer that has spread to other parts of the body, or mental health or personal circumstances that would make it difficult to follow the study requirements
• People with an active autoimmune disease (where the immune system attacks the body's own tissues)
• People who have received any transplanted tissue or organ from another person, including a corneal (eye) transplant, regardless of whether they still need anti-rejection medication
• People whose blood oxygen level is below 92% when breathing normal room air
• People who use supplemental oxygen at home
• People with significant heart disease
• Cohort B only: People whose blood levels of certain heart-related proteins (troponin T or troponin I) are more than twice the upper limit considered normal by the testing laboratory
• People with conditions such as alcohol or drug dependence, other illnesses, or poor vein access that would make it difficult to attend study visits and follow study procedures
• People who are unwilling or unable to follow the study schedule for any reason

Cohorts C and D:

• People who have taken part in another clinical trial or used an experimental medical device within the 28 days before starting this study
• People who are expected to need any other cancer treatment during the study
• People who are currently taking long-term steroid medications on a regular basis
• People who have received a live vaccine within 30 days before starting the study drug
• People who have had a severe allergic reaction to any monoclonal antibody (a type of treatment made from immune cells)
• People who have received any transplanted tissue or organ from another person, including a corneal (eye) transplant, regardless of whether they still need anti-rejection medication
• People who are currently pregnant or breastfeeding
• Cohort D only: People whose blood levels of certain heart-related proteins (troponin T or troponin I) are more than twice the upper limit considered normal by the testing laboratory
• People with conditions such as alcohol or drug dependence, other illnesses, or poor vein access that would make it difficult to attend study visits and follow study procedures
• People where the trial team has determined that participation would not be in their best interest
• People who are unwilling or unable to follow the study schedule for any reason

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