Study on a Personalized Vaccine Combined with Immune Therapy for Patients with Metastatic Colorectal Cancer

Inclusion Criteria

• Have metastatic colorectal cancer confirmed by lab tests and are either starting or have recently started first-line treatment with specific chemotherapy regimens.
• Have cancer that can be measured and cannot be surgically removed.
• Provide a sample of the tumor tissue for analysis.
• Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate organ function based on specific medical tests.
• Women of childbearing potential must agree to use effective birth control during the study and for 150 days after the last treatment.

Exclusion Criteria

• Have certain genetic features in the cancer, like deficient mismatch repair or specific mutations.
• Have a history of bleeding disorders or significant bleeding after injections or blood draws.
• Expect to need immunosuppressive treatment during the study.
• Have had a tissue or organ transplant.
• Have active or past autoimmune diseases or immune deficiencies.
• Have cancer that has spread to the brain or spinal cord and is causing symptoms or worsening.
• Have had another cancer within the last two years, except for certain treated cancers.
• Have severe non-cancer diseases that could interfere with the study.
• Have active infections like tuberculosis, hepatitis B or C, or HIV.
• Have had lung inflammation requiring steroids, except for resolved radiation-related cases.
• Have had a recent heart attack, unstable heart conditions, or severe heart failure.
• Are pregnant, planning to become pregnant, or breastfeeding.