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 at the time of signing the consent form.
• People who are able to understand and sign the consent form for the study.
• People who are willing and able to attend all scheduled visits, follow the treatment plan, complete lab tests, and follow study procedures.
• People who have been diagnosed with colorectal adenocarcinoma (a type of bowel cancer) confirmed through a tissue or cell sample.
• People whose cancer has been confirmed to have a specific genetic change called a BRAF V600E mutation, identified at any point before the screening visit.
• People whose cancer has been confirmed to be of a type called microsatellite stable (MSS) or mismatch-repair proficient (pMMR), tested through local laboratory methods.
• People with colorectal cancer (CRC) who fall into one of these situations:
  • Locally advanced bowel cancer that cannot currently be surgically removed but may become removable, as decided by the local specialist team.
  • Cancer that has spread to a limited number of sites (liver, lungs, lymph nodes, or the lining of the abdomen), where the cancer is either currently removable or may become removable, as decided by the local specialist team.
  • Stage II–IV bowel cancer that was previously treated with chemotherapy before or after surgery, where the cancer has come back more than 6 months after surgery or after finishing chemotherapy (whichever is later), and the returned cancer is either currently removable or may become removable, as decided by the local specialist team.
• People whose general health and ability to carry out daily activities is rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activities).
• People whose cancer can be measured or assessed using standard imaging methods.
• People whose blood counts are at adequate levels at the screening visit (confirm specific values with the trial site).
• People whose liver and kidney function tests are within acceptable ranges at the screening visit (confirm specific values with the trial site).
• People who are able to swallow, keep down, and absorb tablets or capsules taken by mouth.

Who may not be able to join:

• People with a medical or psychiatric condition, including thoughts of or attempts at suicide in the past year, or abnormal lab results that the study doctor believes would make participation unsafe or inappropriate.
• People whose cancer has spread to the lining around the brain or spinal cord, or to the brain itself.
• People with a history of chronic inflammatory bowel disease that required medication or surgery within the 12 months before starting the study treatment.
• People whose cancer has a different genetic change called a RAS mutation.
• People with significant digestive system problems such as uncontrolled nausea, vomiting, diarrhea, poor absorption of nutrients, previous removal of part of the small bowel, or signs of a possible bowel blockage.
• People with significant heart or blood vessel conditions, including:
  • A heart attack or related heart procedure within 6 months before starting the study treatment.
  • Heart failure requiring treatment (at a moderate or severe level).
  • A significant or uncontrolled heart rhythm problem.
  • A stroke, mini-stroke, or significant blood clot in a vein or the lungs within 12 weeks before starting the study treatment (with some exceptions — confirm with trial site).
  • An abnormally long electrical signal in the heart (QTcF interval of 480 ms or more), or a history of a condition called long QT syndrome.
  • An inherited condition called congenital long QT syndrome.
• People with active non-infectious lung inflammation.
• People with an active, uncontrolled bacterial or viral infection within 2 weeks before starting the study treatment (with some exceptions for HIV, hepatitis B, and hepatitis C — confirm with trial site).
• People living with HIV who do not meet all of the following: being on a stable and appropriate antiviral treatment, not needing preventive antibiotics or antifungals, having a CD4 cell count above 250, and having an undetectable HIV level in the blood.
• People with active hepatitis B or hepatitis C infection (as defined by specific test results — confirm with trial site).
• People who have had another cancer within the past 3 years, except for certain skin cancers, some prostate conditions, or cervical or other cancers that were successfully treated with a low chance of returning (confirm with trial site).
• People who still have significant side effects (Grade 2 or higher on a standard scale) from a previous cancer treatment, with the exception of hair loss or nerve-related symptoms at Grade 2.
• People who have previously been treated with certain targeted drugs that block BRAF or MEK (such as encorafenib, dabrafenib, vemurafenib, or similar medicines).
• People who have taken certain medications, herbal products, or supplements that significantly affect how the body processes drugs (moderate or strong CYP3A4/5 inhibitors or inducers) within 1 week before starting the study treatment.
• People who have had major surgery or completed radiotherapy within 4 weeks before starting the study treatment.
• People who have previously received systemic (whole-body) cancer treatment for colorectal cancer, with some exceptions for those who had surgery and chemotherapy and whose cancer did not return for more than 6 months (confirm with trial site).
• People who have already received a first-line treatment course for colorectal cancer that had spread and was not able to be removed by surgery.
• People who have received another experimental drug within 30 days (or 5 half-lives of that drug, whichever is longer) before starting this study.
• People who are known to have a serious reaction or intolerance to a drug called cetuximab, or who would not be able to receive the full required dose.
• People who are known to be sensitive or have a contraindication to any of the other study drugs or their ingredients.
• People who are pregnant or breastfeeding.
• People of childbearing potential who are not willing to use highly effective contraception, or remain abstinent, during the study and for 6 months after the last dose of the study drug.
• People who have had full-dose radiotherapy within 28 days before starting the study treatment (short-course radiotherapy for symptom control may be acceptable — confirm with trial site).
• People with a condition called ulcerative keratitis (a specific type of eye inflammation).

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