Clinical trials /

EMPIRE: Cemiplimab, Fianlimab, and REGN7075

RecruitingPhase 2InterventionalNCT07058012 ↗

This is a study 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.

Sponsor
NSABP Foundation Inc
Planned enrollment
79 participants
Start date
April 17, 2026
Primary completion
April 17, 2029 (est.)
Minimum age
18 Years
Interventions
Cemiplimab, cemiplimab plus fianlimab, cemiplimab + REGN7075, ctDNA testing

Official title: 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

This is a Phase 2 study 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.

Key Eligibility Criteria

  • Patients with confirmed microsatellite stable  stage II-IV colon or rectal cancer
  • Patients must:
    • have complete resection of primary and metastatic disease and completed at least 3 months of a standard systemic chemotherapy regimen
    • have no radiographic evidence of disease at study enrollment
    • have a ctDNA positive assay within 2-12 weeks following completion of definitive all curative therapy for colorectal cancer

Treatment

Drug: Cemiplimab, a PD-1 inhibotor

Drug: Fianlimab, a LAG-3 inhibitor

Drug: REGN7075

ClinicalTrials.gov ID NCT07058012

Regeneron Release Details

Where this trial is offered

  • University of FloridaGainesville, Florida
    Recruiting
  • University of Iowa - Holden Comprehensive Cancer CenterIowa City, Iowa
    Recruiting
  • University of Kansas Cancer CenterKansas City, Kansas
    Recruiting
  • University of Maryland GreenbaumBaltimore, Maryland
    Recruiting
  • Missouri BaptistSt Louis, Missouri
    Recruiting
  • First Health of the CarolinasPinehurst, North Carolina
    Recruiting
  • Allegheny General HospitalPittsburgh, Pennsylvania
    Recruiting
  • Magee-Womens Hospital of UPMCPittsburgh, Pennsylvania
    Recruiting
  • Ballad Health Cancer Center - KingsportKingsport, Tennessee
    Recruiting
  • Huntsman Cancer Institute - University of UtahSalt Lake City, Utah
    Recruiting
  • University of Virginia HealthCharlottesville, Virginia
    Recruiting
  • Bon Secours St. Francis Medical CenterMidlothian, Virginia
    Recruiting
  • Virginia Commonwealth University - MasseyRichmond, Virginia
    Recruiting

Status, sites, and study facts from ClinicalTrials.gov, last posted September 3, 2026 and refreshed here September 5, 2026.View the full record for NCT07058012.