Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer

This is an open-label, non-randomized, phase II study to assess the safety, feasibility, and clinical activity of cemiplimab with fianlimab in patients with resectable colon cancer. All patients will be treated with fianlimab 1600 mg IV plus cemiplimab 350 mg IV on Days 1 and 22. The study will be conducted in two stages: 1) Safety Run-In and 2) Expansion. Approximately 24 patients will be enrolled to ensure 20 evaluable patients.

All patients will complete a medical history, baseline physical examination, and clinical assessment including laboratory studies prior to starting treatment. Physical examination, evaluation of AEs, and safety labs will be conducted while on treatment. Toxicities will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0. All study assessments will be conducted as per the study calendar.

All patients will undergo baseline tumor staging consisting of imaging of the chest, abdomen, and pelvis. Pretreatment tumor biopsies will be taken during colonoscopies. All patients should receive surgical resection of the colon primary from 30 to 60 days after Day 1, unless medically contraindicated or the patient withdraws/is withdrawn from study. Post-treatment tissue is obtained at surgery. Patients may receive adjuvant chemotherapy as per standard of care. Adjuvant chemotherapy may be considered for patients with pathologic stage II/III disease approximately 6-12 weeks after surgery unless medically contraindicated or the patient withdraws/is withdrawn from study. Patients will be followed for recurrence and survival for up to 3 years. Recurrence will be determined by medical provider assessment. Survivorship will be followed according to national guidelines and institutional standard of care.