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)

Part of paid clinical trials in Gainesville, Florida.

Sponsor
NSABP Foundation Inc
Study ID
NCT07058012
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Colo-rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Cemiplimab 350mg intravenously
  • cemiplimab plus fianlimab — DRUG
    Cemiplimab 350mg + Fianlimab 1600mg intravenously
  • cemiplimab + REGN7075 — DRUG
    Cemiplimab 350mg + REGN7075 2700mg intravenously
  • ctDNA testing — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jul 10, 2025
Start date
Apr 17, 2026
Status verified
Jun 2026
Primary completion
Apr 17, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
79 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Arm 1
    cemiplimab
  • Active Comparator: Arm 2
    cemiplimab plus fianlimab
  • Experimental: Arm 3
    cemiplimab plus REGN7075

Primary Outcome Measure

Clearance of cDNA [ Time Frame: From enrollment to 12 weeks ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611-
University of Iowa - Holden Comprehensive Cancer CenterIowa CityIowa52242-
University of Kansas Cancer CenterKansas CityKansas66160-
Missouri BaptistSt LouisMissouri63131-
First Health of the CarolinasPinehurstNorth Carolina28374-
Allegheny General HospitalPittsburghPennsylvania15212-
Ballad Health Cancer Center - KingsportKingsportTennessee37660-
Bon Secours St. Francis Medical CenterMidlothianVirginia23114-
Virginia Commonwealth University - MasseyRichmondVirginia23298-

Find similar trials in Gainesville, FL

By research site
University of Florida· Gainesville, FLUniversity of Iowa - Holden Comprehensive Cancer Center· Iowa City, IAUniversity of Kansas Cancer Center· Kansas City, KSMissouri Baptist· St Louis, MOFirst Health of the Carolinas· Pinehurst, NCAllegheny General Hospital· Pittsburgh, PA

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