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)

ClinicalTrials.gov ID: NCT07058012

Public ClinicalTrials.gov record NCT07058012. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:57 AM EDT

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07058012
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: NSABP Foundation Inc; Network
Enrollment: 79 participants

Conditions and interventions

Conditions

Colo-rectal Cancer

Interventions

Drug · Other

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 16, 2026
Primary completion: Apr 16, 2029
Completion: May 31, 2029
Last update posted: Jun 11, 2026

2026 – 2029

United States locations

U.S. sites: 9
U.S. states: 8
U.S. cities: 9

Facility	City	State	ZIP	Site status
University of Florida	Gainesville	Florida	32611	Recruiting
University of Iowa - Holden Comprehensive Cancer Center	Iowa City	Iowa	52242	Recruiting
University of Kansas Cancer Center	Kansas City	Kansas	66160	Recruiting
Missouri Baptist	St Louis	Missouri	63131	Recruiting
First Health of the Carolinas	Pinehurst	North Carolina	28374	Recruiting
Allegheny General Hospital	Pittsburgh	Pennsylvania	15212	Recruiting
Ballad Health Cancer Center - Kingsport	Kingsport	Tennessee	37660	Recruiting
Bon Secours St. Francis Medical Center	Midlothian	Virginia	23114	Recruiting
Virginia Commonwealth University - Massey	Richmond	Virginia	23298	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07058012, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 11, 2026 · Synced Sep 2, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07058012 live on ClinicalTrials.gov.

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