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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) | Clinical Trials | Clareo Health

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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)

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•NSABP Foundation Inc

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated appropriate Institutional Review Board (IRB) -approved consent forms that conform to federal and institutional guidelines for study treatment.
•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 adenocarcinoma (per AJCC 8th edition).
•There must be documentation by CT scan with contrast that the patient has no definitive evidence of metastatic disease including assessment of chest, abdomen, and pelvis at the time of study enrollment
•Psychiatric or addictive disorders or other conditions that in the opinion of the investigator would preclude the patient from meeting the study requirements or interfering with interpretation of study results.
•Pregnancy or lactation at the time of study entry.
•Use of any investigational agent within 28 days prior to the first dose of study therapy.

Exclusion Criteria

•* Patients must be ctDNA-positive by an assay run in any CLIA-certified lab obtained within 2-12 weeks following completion of definitive all curative therapy for colorectal cancer.
•* Tumor status of microsatellite stability (MSS) or Proficient mismatch repair (pMMR) is confirmed through a standard of care assay through a CLIA-certified lab.
•At the time of study entry, blood counts performed within 28 days prior to study entry must meet the following criteria:
•* ANC must be greater than or equal to (≥) 1000/mm3,
•* Platelet count must be ≥ to 80,000/mm3; and
•* Hemoglobin must be ≥ 8 g/dL. (Note: transfusions may be used to correct hemoglobin for patients experiencing anemia from therapy who otherwise would be eligible for the study.)
•* Albumin greater than (\>) 3.0 g/dL.
•The following criteria for evidence of adequate hepatic function performed within 28 days prior to study entry must be met:
•* Total bilirubin less than or equal to (≤) 1.5 x ULN
•* AST and ALT must be ≤ 3.0 x ULN for the lab. (Note: In patients with elevated ALT or AST, the values must be stable for at least 2 weeks and with no evidence of biliary obstruction on imaging.)
+24 more criteria

Key Dates

Start Date

August 1, 2025

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2029

Last Updated

July 10, 2025

Enrollment

ESTIMATED participants

Conditions

Colo-rectal Cancer

Interventions

Cemiplimab

DRUG

cemiplimab plus fianlimab

DRUG

cemiplimab + REGN7075

DRUG

ctDNA testing

OTHER

Contacts

Department of Site and Study Management (DSSM)

CONTACT

1-800-270-3165 industry.trials@nsabp.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

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