NCT07058012View on ClinicalTrials.gov

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)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

June 1, 2028

Study Completion Date

June 1, 2029

Conditions
Colo-rectal Cancer
Interventions
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.

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

NSABP Foundation Inc

NETWORK