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)

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.

Timeline

Start

2026-04-17

Primary completion

2029-04-17

Completion

2029-06-01

Publications

• Saeed A, Yothers G, Puhalla SL, Tojjari A, Rastogi P, Freeman TJ, Mathias MD, Seebach FA, Wolmark N, George TJ. EMPIRE (NSABP FC-13): a biomarker-driven phase II platform trial evaluating cemiplimab-based immunotherapy in microsatellite-stable colorectal cancer with ctDNA-defined minimal residual disease. Future Oncol. 2026 Jun 25:1-9. doi: 10.1080/14796694.2026.2688569. Online ahead of print.

Drugs

Indications