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)

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.

Trial Details

NCT ID
NCT07058012
Phase
PHASE2
Sponsor
NSABP Foundation Inc
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Cemiplimab
  • cemiplimab plus fianlimab
  • cemiplimab + REGN7075
  • ctDNA testing
Locations (sample)
  • Gainesville, Florida, United States|29.65163,-82.32483
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Kansas City, Kansas, United States|39.11417,-94.62746
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Pinehurst, North Carolina, United States|35.19543,-79.46948

Key Eligibility Criteria

  • The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated appropriate Institutio…
  • Patients must be greater than or equal to18 years old.
  • The ECOG performance status must be 0-1.
  • Patients must have confirmed histologic and pathologic stage II/III colon, stage II/III rectal, or oligometastatic stage IV colorectal adenocarcino…

For full eligibility, visit ClinicalTrials.gov.

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