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 given written consent to take part in the study.
• People aged between 18 and 75 years old.
• People who have been diagnosed with colorectal cancer (a type of bowel cancer) that has spread to other parts of the body and cannot be removed by surgery, confirmed through a tissue or cell sample.
• People whose cancer has continued to grow, or who could not tolerate, previous standard treatments — which must have included specific chemotherapy drugs (fluoropyrimidine, irinotecan, and oxaliplatin), with or without certain targeted therapy drugs (bevacizumab, cetuximab, or panitumumab).
• People whose cancer has been tested and confirmed to be a specific type based on how cancer cells repair DNA — known as MSS, MSI-L, or pMMR (confirm with trial site for what this means for your situation).
• People who have already had their cancer tested for a gene called KRAS, regardless of the result.
• People whose cancer can be measured on scans according to a standard set of rules called RECIST v1.1.
• People who are generally well enough to carry out light activity and look after themselves, based on a standard health scale (ECOG performance status of 0 or 1).
• People whose liver, kidneys, blood, and other organs are working well enough (confirm with trial site for specific thresholds).
• People who are expected to live for more than 12 weeks.

Who may not be able to join:

• People who have previously been treated with a type of drug called an HDAC inhibitor.
• People who have previously received immunotherapy drugs that target PD-1, PD-L1, CTLA-4, or similar immune checkpoint pathways.
• People who have previously taken a certain type of targeted therapy tablet or capsule that blocks blood vessel growth (small-molecule VEGF receptor inhibitors).
• People who have received any cancer treatment or experimental treatment within 28 days before starting the study.
• People who have had radiotherapy within 28 days before starting the study.
• People in the control group of the trial who plan to use a specific combination of study drugs after the study ends (confirm with trial site).
• People who have had an autoimmune disease (where the immune system attacks the body) requiring ongoing treatment at any point in the past 2 years.
• People with a known history of a condition where the immune system does not work properly from birth or early life (primary immunodeficiency).
• People who have taken drugs that suppress the immune system within 28 days before starting the study.
• People who have taken drugs that stimulate the immune system within 28 days before starting the study.
• People who have had major surgery within 28 days before starting the study.
• People who have received a live vaccine within 28 days before starting the study, or who plan to receive one during the study.
• People who are still experiencing significant side effects from previous cancer treatment that have not returned to a mild or resolved level.
• People with diabetes that is not well controlled, assessed within 7 days before starting the study.
• People who have cancer that has spread to the brain or spinal cord and is causing symptoms that have not been treated.
• People with serious heart or blood vessel problems that are not under control.
• People who have had a stroke within the past 6 months.
• People who have had a serious blood clot in a vein or artery within the past 6 months.
• People who have had a hole or abnormal opening in the stomach or bowel within the past 6 months.
• People with significant digestive system problems during the screening period that may affect how the study drugs are absorbed or processed.
• People with a known history of bleeding disorders or problems with blood clotting.
• People currently taking blood thinning or clot-dissolving medications during the screening period.
• People with fluid build-up around the lungs, heart, or abdomen that is not controlled and has needed draining within 14 days before starting the study.
• People with suspected scarring or inflammation of the lungs that requires treatment.
• People with a severe or active infection that requires treatment with medication.
• People with active tuberculosis of the lungs.
• People with active hepatitis B or hepatitis C infection.
• People who are HIV positive or have a syphilis infection.
• People with a history of another type of cancer.
• People who have had an organ transplant or a stem cell transplant from a donor.
• People who are known to be allergic to the study drugs or any of their ingredients.
• People with a history of alcohol or drug misuse.
• People who are unwilling or unable to follow the study procedures.
• People who are pregnant or breastfeeding, or people who are unwilling or unable to use a highly effective form of contraception during the study.
• People whom the trial doctor considers unsuitable for any other reason.

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