NCT07058012

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)

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (estimated)
• Sponsor: NSABP Foundation Inc · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colo-rectal Cancer

Interventions

Type	Name	Description
DRUG	Cemiplimab	Cemiplimab 350mg intravenously
DRUG	cemiplimab plus fianlimab	Cemiplimab 350mg + Fianlimab 1600mg intravenously
DRUG	cemiplimab + REGN7075	Cemiplimab 350mg + REGN7075 2700mg intravenously
OTHER	ctDNA testing	Eligible patients using results for ctDNA-positivity as obtained from a commercial assay run in any CLIA-certified lab will proceed to enrollment and begin treatment. All patients will have confirmation of ctDNA-positivity via the Signatera\^TM assay (Clinical Trial Assay), but treatment may proceed while awaiting confirmatory results.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2025-07-10
• Last updated: 2025-07-10

Regulatory

• FDA-regulated drug study
• FDA-regulated device study