Study of Botensilimab and Balstilimab for Colorectal Cancer with ctDNA+ After Surgery and Chemotherapy

Inclusion Criteria

• Must be willing and able to provide written consent.
• Have a confirmed diagnosis of colorectal cancer.
• Be 18 years or older.
• Agree to provide tissue and blood samples for research.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have a specific type of colorectal cancer (non-MSI-H/pMMR) confirmed by tests.
• Agree to undergo additional genetic testing if not previously done.
• Specific criteria for different groups:
  • Group 1a and 2a: Completed surgery and chemotherapy for stage III colon cancer.
  • Group 1b and 2b: Completed surgery and chemotherapy for liver metastases.
• Have positive ctDNA after standard treatment, with the option to retest within 6 months if initially negative.
• Sign consent within 4 weeks of a positive ctDNA result.
• Have adequate organ function as shown by specific blood tests.
• Use effective birth control during the study and for 5 months after the last treatment.

Exclusion Criteria

• Have metastatic or recurrent cancer.
• Have certain genetic mutations (POLE or POLD).
• Have residual tumor after surgery.
• Currently in another study or have been in one recently.
• Have an immune deficiency or are on immunosuppressive therapy.
• Have allergies to the study drugs.
• Have had recent chemotherapy or radiation therapy.
• Have a history of lung inflammation or active infection.
• Have conditions that could interfere with the study.
• Have psychiatric or substance abuse issues affecting participation.
• Are pregnant, breastfeeding, or planning to conceive during the study.
• Have had prior treatment with similar drugs.
• Have active autoimmune diseases requiring treatment.
• Have active tuberculosis or uncontrolled HIV.
• Have active hepatitis B or C.
• Have received a live vaccine recently.