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)

About the trial

Sponsor

NSABP Foundation Inc (with Regeneron Pharmaceuticals)

Tested

Cemiplimab (drug), cemiplimab plus fianlimab (drug), cemiplimab + REGN7075 (drug), ctDNA testing (other)

Dates

Started 2026-04-17; completion 2029-06-01

Results posted

Not yet

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.

From ClinicalTrials.gov, last updated 2026-09-03. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Regeneron Pharmaceuticals, Inc. reported $112,627 in research payments for this study in 2025 (3 payments).

Products named: Libtayo

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.