NCT07224022

Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer

NACho: A Study of Neo-Adjuvant Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: John Strickler, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a research study to test whether two immunotherapy drugs-cemiplimab and fianlimab-can safely and effectively shrink colon tumors before surgery in people with stage II-III colon cancer that has not spread to other parts of the body. Participants will receive two doses of the study drugs through an IV (one on Day 1 and one on Day 22). During the study, participants will have regular visits to the study clinic and multiple tests for safety and research purposes, including blood tests, along with other tests and scans, followed by surgery to remove the tumor. The study will follow participants' health for up to three years after surgery. Risks of cemiplimab and fianlimab include fatigue, diarrhea, skin rash, thyroid problems, and immune-related side effects such as inflammation of the lungs, liver, or intestines.

Detailed description

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of the colon primary from 30 to 60 days after Day 1, unless medically contraindicated or the patient withdraws/is withdrawn from study.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.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]	Immune checkpoint inhibition with antibodies directed against PD-1 and CTLA-4 receptors have demonstrated significant and durable efficacy in several advanced malignancies. LAG-3 is classified as an immune checkpoint protein that negatively regulates T cell activity, similar to PD-1 and CTLA-4. Blockade of LAG-3 with antibodies such as fianlimab, especially in combination with anti-PD-1 therapy, may represent a potentially effective or enhanced treatment for advanced malignancies. We hypothesize that cemiplimab in combination with fianlimab is feasible, safe, and effective neoadjuvant treatment strategy for early-stage colon cancer.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-04-01
• Completion: 2029-07-01
• First posted: 2025-11-03
• Last updated: 2026-02-04

Regulatory

• FDA-regulated drug study