Phase II Study on Cemiplimab Alone or with Fianlimab for Colorectal Cancer After Surgery and Chemotherapy

Inclusion Criteria

• Must agree to participate and sign consent forms.
• Must be 18 years or older.
• Must have a performance status of 0-1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Must have stage II/III colon, stage II/III rectal, or certain stage IV colorectal cancer confirmed by tests.
• Must have no signs of cancer spread on a CT scan.
• Must have had complete removal of the primary tumor and any small metastatic disease, plus at least 3 months of standard chemotherapy.
• Must test positive for ctDNA within 2 weeks to 12 months after finishing all curative treatment.
• Must have stable microsatellite status or proficient mismatch repair confirmed by tests.
• Must meet specific blood count and liver function criteria.
• Must have no opportunistic infections.
• Women of childbearing potential must have a negative pregnancy test before starting treatment.
• Must agree to use effective contraception during and for 6 months after treatment.

Exclusion Criteria

• Have colon cancer types other than adenocarcinoma.
• Have tumors with high microsatellite instability.
• Have received recent anti-cancer therapy or have immune-related side effects from previous treatments.
• Have active or past tuberculosis infection.
• Have untreated or uncontrolled infections.
• Have autoimmune diseases requiring immunosuppressive therapy, except for certain mild conditions.
• Be on systemic steroid therapy that cannot be stopped.
• Have received a live vaccine within 30 days before the study.
• Have active hepatitis B or C infections.
• Have had an organ or bone marrow transplant.
• Have certain heart conditions or recent heart events.
• Have active inflammatory bowel disease.
• Have had major surgery within 28 days before the study.
• Have other cancers unless disease-free for 36 months, except for certain skin or cervical cancers treated within 12 months.
• Have psychiatric or addictive disorders affecting study participation.
• Be pregnant or breastfeeding.
• Have used investigational agents within 28 days before starting the study.