Phase 2 Colorectal Cancer Trial, Recruiting

Written by an AI model from the 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 to 80 years who have signed a consent form before enrolling
• People diagnosed with advanced colorectal cancer that has a specific genetic feature called dMMR or MSI-H, confirmed through tissue or cell testing combined with imaging scans
• People with a general health and activity level rated 0 to 2 on a standard medical scale (meaning able to carry out at least some daily activities)
• People who have at least one tumour area large enough to be measured on a CT scan, according to specific size guidelines
• People whose blood cell counts fall within acceptable ranges — including white blood cells, platelets, and haemoglobin levels (confirm specific values with trial site)
• People whose liver function test results are within acceptable limits, and whose liver protein levels are sufficient
• People whose kidney function meets the required levels, either through a blood test or a calculated kidney clearance rate
• People whose blood clotting results are within acceptable ranges (those already on blood-thinning medication may still be eligible if their results fall within the appropriate range for that medication)
• People with an expected survival of at least 3 months
• Women who are not pregnant or breastfeeding, and who are willing to use an approved form of contraception during the study and for at least 120 days after it ends, and who agree not to donate or freeze eggs during this period

Who may not be able to join:

• People who have brain metastases (cancer that has spread to the brain) that are causing symptoms
• People who have had a different type of cancer (other than colorectal cancer) within the past 3 years
• People with an active autoimmune disease or one likely to return — such as autoimmune hepatitis, interstitial pneumonia, uveitis, bowel inflammation, pituitary inflammation, vasculitis, nephritis, or thyroid conditions (including those who have had thyroid surgery); people with vitiligo or fully resolved childhood asthma that requires no ongoing treatment may still be eligible (confirm with trial site)
• People with severe or uncontrolled high blood pressure, poorly controlled diabetes, or significant heart problems including heart attack, certain irregular heart rhythms, or moderate-to-severe heart failure
• People with a serious active or uncontrolled infection requiring treatment with antibiotics, antifungal, or antiviral medicines
• People with active hepatitis B or C at levels above specified thresholds (those on antiviral treatment who have brought levels below the threshold may still be eligible; confirm with trial site)
• People who require dialysis due to kidney failure
• People with a history of immune system deficiency, including HIV, other immune conditions, or a history of organ transplantation
• People who have required systemic treatment for an autoimmune disease within the past 2 years (some hormone replacement therapies may be exempt — confirm with trial site)
• People currently taking corticosteroids at doses above 10 mg per day of prednisone or equivalent, or any immunosuppressive medicines, within 2 weeks of the first study dose
• People with a history of active tuberculosis, or those currently being treated for tuberculosis
• People whose fluid build-up (such as in the abdomen, around the heart, or in the lungs) cannot be controlled and repeatedly requires draining
• People who have had a major organ transplant
• People who have had major surgery, a tissue biopsy, or a significant injury within 28 days before starting the study, or who have an untreated wound or fracture
• People who have received a live vaccine within 14 days before starting the study, or who plan to receive one during the study
• People who have had a severe allergic reaction to a monoclonal antibody, or who are known to be allergic to any ingredients in the study medicines (including envafolimab or lenvatinib)
• People who are currently participating in, or have participated in, another clinical trial within 4 weeks before starting this study
• People who have previously received a specific type of combined immunotherapy treatment targeting both PD-1 and CTLA-4
• People with a history of severe allergies
• Women who are pregnant or breastfeeding
• People with a bleeding risk, clotting disorders, or who are currently on clot-dissolving therapy
• People with a history of substance misuse who are unable to stop, or people with a psychiatric disorder
• People whose overall health or other circumstances are judged by the trial doctor to make participation unsafe or unsuitable

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