Clinical Trial

Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer

Study acronym: NACho
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2028-04 -> 2028-08-31 2026-05-07
minor Completion pushed: 2029-07 -> 2029-11-30 2026-05-07
Trial Details
NCT Number NCT07224022
Lead Sponsor John Strickler, M.D.
Collaborators: Regeneron Pharmaceuticals
Conditions Colon Cancer
Enrollment 24 participants
Start Date 2026-07-01
Primary Completion 2028-08-31 (estimated)
Study Completion 2029-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-06