drugset / Trial / NCT07224022

Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer

NCT07224022

Phase 2 Not yet recruiting 24 enrolled John Strickler, M.D. Regeneron Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-07-01
Primary completion
2028-08-31
Completion
2029-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cemiplimab Monoclonal antibody 350 mg Intravenous
Subject Fianlimab Monoclonal antibody 1600 mg Intravenous

Indications