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 who are 18 years of age or older at the time of signing the consent form
• People who have been diagnosed with colorectal cancer that has spread to other parts of the body (metastatic), confirmed by a laboratory test on tissue or cell samples
• People whose tumour has been tested and found to have a specific gene change called BRAF V600E mutation
• People whose tumour has been confirmed to be microsatellite stable (MSS) — a particular characteristic of the tumour's DNA repair system
• People whose tumour RAS status makes them eligible to receive the drug cetuximab, according to local medical guidelines
• People whose cancer has gotten worse after 1 or 2 previous treatment regimens for metastatic disease
• People who have measurable or evaluable disease that can be tracked on scans, according to standard criteria (RECIST v1.1)
• People who are in good general health, rated 0 or 1 on a standard performance scale (meaning fully active or able to carry out light activity)
• People whose blood counts are at acceptable levels at screening: enough white blood cells, platelets, and haemoglobin
• People whose liver and kidney function test results are within acceptable ranges at screening, including normal enough bilirubin, liver enzyme (ALT/AST), kidney filtration rate, protein in urine, and electrolyte (potassium and magnesium) levels
• People whose heart function meets the required standard, specifically a certain heart rhythm measurement (QTcF) of 480 milliseconds or less
• People who are able to swallow and take oral (by mouth) medications
• People who are willing and able to use highly effective contraception during the study and for at least 6 months after the last dose of study medication, where there is any risk of pregnancy (confirm details with trial site)
• People who have signed and dated the informed consent form

Who may not be able to join:

• People who are currently participating in another clinical trial or have done so within 30 days before enrolling
• People who are unable to follow the study requirements due to psychological, social, or geographic reasons
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period
• People who have a history of a severe high blood pressure crisis or high blood pressure affecting the brain
• People who have had serious blood vessel disease (such as a large aortic aneurysm needing surgery, or a recent blood clot in an artery) within 6 months before starting treatment
• People who have a known bleeding disorder or significant problems with blood clotting (not related to blood-thinning medication)
• People who have had significant coughing up of blood within 6 months before starting treatment
• People with a known history of acute or chronic pancreatitis (inflammation of the pancreas)
• People whose tumour has a characteristic called microsatellite instability (MSI) or mismatch repair deficiency (dMMR)
• People with a history of chronic inflammatory bowel disease or Crohn's disease that required medication or surgery within 12 months before enrolling
• People who have had a heart attack, unstable chest pain, or certain heart procedures (such as bypass surgery or stenting) within 6 months before starting treatment
• People with significant heart failure symptoms, or certain heart rhythm or conduction problems within 6 months before starting treatment (some types of irregular heartbeat may be considered separately — confirm with trial site)
• People with uncontrolled high blood pressure that remains high despite current treatment (systolic 150 mmHg or higher, or diastolic 100 mmHg or higher)
• People with significantly reduced liver function (classified as Child-Pugh class B or C)
• People with a known history of HIV, or active hepatitis B or hepatitis C infection (some people with past exposure to hepatitis B or C may still be eligible depending on test results — confirm with trial site)
• People with spinal cord compression, or brain or nervous system metastases that are untreated, causing symptoms, or currently requiring steroids or anti-seizure medications (people with treated and stable brain metastases that are no longer causing symptoms may be considered, provided at least 2 weeks have passed since completing whole-brain radiotherapy)
• People with cancer spread to the membranes surrounding the brain and spinal cord (leptomeningeal carcinomatosis)
• People with significant digestive system problems that could affect how the body absorbs the study drug (such as active ulcers, uncontrolled vomiting, malabsorption conditions, or significant bowel removal)
• People who have had another cancer within the past 5 years, unless it was a type considered fully cured and low-risk (such as certain skin cancers or early-stage cervical changes) — sponsor approval may be required in some cases
• People who have had a blood clot in a vein or artery, a stroke, or a mini-stroke (TIA) within 6 months before starting treatment
• People with any other known medical condition or medication that could interfere with the study treatment
• People with known severe allergic reactions to monoclonal antibody treatments or BRAF inhibitor medications
• People with known hypersensitivity (allergy) to any of the study drugs — encorafenib, cetuximab, or bevacizumab-bvzr — or to any of their ingredients

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