Study on Cemiplimab With or Without Fianlimab for Treating Older Patients with Localized or Advanced MSI-H Colorectal Cancer

Inclusion Criteria

• Be 70 years or older.
• Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
• Have a confirmed diagnosis of localized or locally advanced colorectal cancer with specific genetic features (dMMR or MSI-H).
• Have not received any previous systemic treatment or radiation for this cancer.
• Agree to regular endoscopic and CT scans for 24 months.
• Agree to have a tumor biopsy.
• Have adequate organ and bone marrow function as shown by specific lab tests.
• Use an acceptable form of birth control during the study.
• Be able to understand and willing to sign a consent form.

Exclusion Criteria

• Have used an experimental drug or device within 28 days before starting the study treatment.
• Need any other cancer treatment while participating in the study.
• Have had surgery within 28 days before starting the study treatment, except for minor procedures.
• Have been treated with certain immune therapies in the past 5 years before their colorectal cancer diagnosis.
• Are currently using long-term systemic steroids.
• Have had a severe allergic reaction to any monoclonal antibody.
• Have uncontrolled illnesses, such as infections, heart failure, unstable chest pain, irregular heartbeats, or psychiatric conditions that would interfere with the study.
• Have an active autoimmune disease.
• Have had any tissue or organ transplant, including corneal transplants.
• Are on supplemental home oxygen.
• Have significant heart disease.
• Have conditions, including substance dependence or lack of sufficient vein access, that would affect their ability to comply with study visits and procedures.
• Are unwilling or unable to follow the study schedule for any reason.