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:

• You have been diagnosed with colorectal cancer that has spread (metastatic) and cannot be surgically removed, and lab tests confirm it is a specific type (MSS/pMMR with a RAS gene mutation)
• You are generally active and able to care for yourself, with only mild limitations on daily activities (performance score of 0 or 1)
• You are able to swallow tablets or capsules
• You have at least one tumor that can be measured on a scan, following standard measurement guidelines
• You have not yet received any anti-cancer treatment for your metastatic or recurrent disease
• If you previously had chemotherapy before or after surgery to remove colorectal cancer, that treatment must have been fully completed at least 6 months ago (or at least 12 months ago if it included a drug called oxaliplatin)
• Your blood counts, liver, kidneys, heart, and urine are all working well enough to meet specific health thresholds (confirm exact values with trial site)
• Your doctor expects you to live for at least 3 more months
• You fully understand the study, agree to take part, and have signed a consent form
• If you could become pregnant or could father a child, you agree to use effective contraception during the trial and for 6 months after the last treatment

Who may not be able to join:

• You have previously been treated with certain immunotherapy drugs, including bevacizumab, anti-PD-1, anti-PD-L1, or anti-CTLA4 medications
• You received radiotherapy within the 4 weeks before being assessed for the trial
• You have significant nerve damage in your hands or feet (peripheral neuropathy above grade 2)
• You received a live vaccine or immune-stimulating medication (such as interferon or interleukin-2) within the past month
• You are HIV-positive or have another immune deficiency condition
• You currently have active hepatitis B or hepatitis C (some exceptions may apply — confirm with trial site)
• You have an active autoimmune disease or condition requiring immune-suppressing treatment (some exceptions, such as controlled thyroid conditions or certain skin conditions, may apply — confirm with trial site)
• You have taken steroid medications or other immune-suppressing treatments at a significant dose within the past 7 days (some exceptions may apply — confirm with trial site)
• You have previously had an organ transplant
• You have brain or spinal cord metastases that are causing symptoms or are not under control
• You have had major surgery, a significant injury, or a large biopsy within the past month, or you may need major surgery during the study
• You currently have another active cancer (some exceptions for certain skin cancers or cancers that were fully treated more than 1 year ago with no signs of return — confirm with trial site)
• You have a serious, active infection that is not responding to treatment
• You have significant heart or blood vessel problems, such as a recent heart attack or stroke (within 6 months), uncontrolled high blood pressure, serious heart rhythm problems, or recent blood clot or major bleeding events
• You have a condition that affects your blood's ability to clot normally
• You have serious digestive problems such as difficulty swallowing, active stomach ulcers, bowel obstruction, active gastrointestinal bleeding, or uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
• You have severe wounds, ulcers, or fractures that have not healed
• You have a serious medical, mental health, or social condition that could affect your ability to participate safely or follow the study requirements
• You are currently pregnant or breastfeeding
• You are taking blood-thinning medications, anti-platelet drugs, or certain anti-inflammatory medications (low-dose aspirin at or below 325 mg/day may be allowed — confirm with trial site)
• You have had a severe allergic reaction to any of the study drugs
• You are receiving a bone-targeted drug called denosumab (Prolia/Xgeva) and are unwilling to switch to an alternative treatment such as bisphosphonates

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