Clinical Trial

A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)

Study acronym: EMPIRE
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The NSABP FC-13 study is being done to determine if using immunotherapies alone or in combination with other drugs will delay or prevent colorectal cancer from coming back in patients with colorectal cancer who are ctDNA-positive after their treatment. Immunotherapeutic drugs (immunotherapies) act on different proteins on the surface of cells of the immune system and trigger the immune system to destroy cancer cells. The drugs being studied in NSABP FC-13 are cemiplimab, fianlimab, and REGN7075.
Protocol Amendment History 1 change
notable Trial sites expanded: 1 -> 9 locations 2026-06-13
Trial Details
NCT Number NCT07058012
Lead Sponsor NSABP Foundation Inc
Collaborators: Regeneron Pharmaceuticals
Conditions Colo-rectal Cancer
Enrollment 79 participants
Start Date 2026-04-17
Primary Completion 2029-04-17 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-12