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 who are able to give signed consent to participate.
• People who have been confirmed (through a tissue or cell sample) to have advanced or metastatic cancer of the colon or rectum (a type called adenocarcinoma).
• People whose cancer has been tested for a specific marker called MMR or MSI status using standard local testing methods.
• Cohort 1 (for people with MSI-H/dMMR cancer that has stopped responding to immunotherapy): People whose cancer is MSI-H or dMMR, who have shown clear signs that their cancer progressed during or after treatment with immune checkpoint inhibitors (including anti-PD-1, with or without anti-CTLA-4 therapy), who received at least 2 doses of a PD-1/PD-L1 inhibitor, whose cancer progressed either during treatment or within 3 months of the last dose, and who did not experience severe (grade 3 or higher) immune-related side effects requiring prolonged immune-suppressing treatment (more than 6 weeks).
• Cohort 2 (for people with pMMR cancer with liver spread): People whose cancer is pMMR or non-MSI-H, who have active cancer spread to the liver confirmed by imaging, where no single liver tumour is larger than 5.0 cm.
• Cohort 3 (for people with pMMR cancer without liver spread): People whose cancer is pMMR or non-MSI-H, with no current liver spread on imaging (though previously treated or surgically removed liver spread is allowed if treatment was more than 6 months ago and the liver has not progressed since).
• People in Cohorts 2 and 3 whose cancer has been tested for RAS and BRAF gene markers using standard local testing.
• People in Cohorts 2 and 3 whose cancer has progressed or who could not tolerate prior treatment with standard chemotherapy drugs (fluoropyrimidine, irinotecan, and oxaliplatin), with documented progression within 6 months before joining the study.
• People with a general health and activity level rated as 0 or 1 on the ECOG scale (meaning fully active or restricted in physically strenuous activity but able to do light work).
• People whose blood and organ function test results fall within acceptable ranges when tested within 7 days before starting treatment (covering liver function, kidney function, blood cell counts, and clotting measures) (confirm specific values with the trial site).
• People who have measurable cancer that can be tracked using standard imaging criteria.
• People who are able to provide a tumour tissue sample — either a fresh biopsy or stored tissue — at the screening stage.
• People with a life expectancy of more than 3 months.
• Women who could become pregnant, and men who are sexually active with women who could become pregnant, who agree to use effective contraception during the study and for 4 months after the last dose of the study drug. Men must also agree not to donate sperm during this period.

Who may not be able to join:

• People in Cohort 2 who have any single liver tumour larger than 5.0 cm.
• People in Cohorts 2 and 3 who have previously been treated with PD-1, PD-L1, or CTLA-4 inhibitor therapies (unless their cancer is MSI-H/dMMR).
• People in Cohort 1 who stopped immune checkpoint inhibitor therapy because of certain grade 2 side effects affecting the nervous system, heart, eyes, or due to recurring lung inflammation.
• People who received anti-cancer treatment within 14 days (or within 5 half-lives of the drug, whichever is sooner) before the first study dose.
• People who still have significant unresolved side effects (grade 2 or higher) from previous cancer treatments.
• People who have had a serious blood clot in an artery or vein, a mini-stroke or stroke, a hypertensive crisis, or hypertensive brain swelling within the past 12 months.
• People who have had unstable angina, a heart attack, significant heart failure, or unstable vascular disease requiring hospitalisation within the past 12 months, or other heart problems that could affect safety during the study.
• People who have had a flare-up of chronic obstructive pulmonary disease (a lung condition) within 4 weeks before joining.
• People with poorly controlled high blood pressure (repeated readings at or above 150/100 mmHg) despite taking blood pressure medication.
• People with an active autoimmune disease or lung disease that has required systemic treatment within the past 2 years (some exceptions apply, such as hormone replacement therapy or inhaled medications — confirm with the trial site).
• People with a known history of serious stomach or bowel problems within the past 6 months, including oesophageal or gastric varices, severe ulcers, wounds that will not heal, abdominal fistulas, internal abscesses, or acute gastrointestinal bleeding.
• People who have had a bowel perforation or fistula, bowel obstruction requiring nutritional support through a drip, or major bowel surgery within the past 6 months.
• People with a history of significant bleeding problems or blood clotting disorders, or who have had clinically significant bleeding symptoms within the past 4 weeks (including coughing up blood or significant nosebleeds), or whose anticoagulant or blood-thinning medication is not stable.
• People whose tumour is growing into or close to major blood vessels or organs such as the heart, windpipe, food pipe, or major veins, in a way that creates a risk of serious internal connections (fistulas) forming.
• People with brain metastases that are causing symptoms, showing signs of bleeding, are larger than 1.5 cm, or who have received brain radiation within 7 days before starting the study, or who have cancer spread to the lining of the brain.
• People who have received a live or live-attenuated vaccine within 4 weeks before planned enrolment, or who are expected to need one during the study.
• People who have had a severe infection within 4 weeks before enrolment, or an active infection requiring systemic treatment within 2 weeks before enrolment. (People with HIV, hepatitis B, or hepatitis C may be considered if their viral load is undetectable on antiviral treatment — confirm with trial site.)
• People who have pre-existing nerve damage (peripheral neuropathy) at grade 2 or higher.
• People who have had major surgery or serious injury within 4 weeks before enrolment, or who are expected to need major surgery within 4 weeks after the first dose.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that is causing symptoms. (People managed with a drainage catheter may be considered — confirm with trial site.)
• People with a history of non-infectious lung inflammation that required steroid treatment, or who currently have interstitial lung disease.
• People with active or past inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, or chronic diarrhoea.
• People who have previously had an organ transplant or bone marrow/stem cell transplant from a donor.
• People with a known allergy to any component of the study drugs, or a history of severe allergic reactions to other monoclonal antibody treatments.
• People with other significant medical or psychiatric conditions that, in the treating doctor's opinion, could interfere with safe participation or the interpretation of results.
• People who have been taking corticosteroids (at doses above 10 mg prednisone daily or equivalent) or other immune-suppressing medications within 14 days before starting the study (some exceptions apply — confirm with trial site).
• People who are pregnant or breastfeeding.
• People whose personal, family, or social situation may make it difficult to follow the study schedule and requirements.

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