STUDY 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

NCT07058012

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.

Status: Not yet Recruiting

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

Study Plan