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)

NCT07058012 | Not Yet Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: NSABP FC-13
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Clearance of cDNA

  To determine the proportion of patients who convert from ctDNA positive at baseline (a condition of eligibility) to ctDNA negative at the 12 week timepoint

  From enrollment to 12 weeks

Secondary Outcomes (7)

• Sustainability of clearance of ctDNA

  From enrollment to 12 months

• Sustainability of clearance of ctDNA

  From enrollment to 18 months

• Kinetics of ctDNA clearance in MRD in patients crossing over from cemiplimab monotherapy

  From crossover to 18 months after enrollment

• MRD Response by quantitative ctDNA

  From enrollment up to 3 years

• Recurrence-free survival (RFS)

  From enrollment up to 3 years

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

cemiplimab

Drug: Cemiplimab; Other: ctDNA testing

Arm 2

ACTIVE COMPARATOR

cemiplimab plus fianlimab

Drug: cemiplimab plus fianlimab; Other: ctDNA testing

Arm 3

EXPERIMENTAL

cemiplimab plus REGN7075

Drug: cemiplimab + REGN7075; Other: ctDNA testing

Interventions

Cemiplimab DRUG

Cemiplimab 350mg intravenously

Arm 1

cemiplimab plus fianlimab DRUG

Cemiplimab 350mg + Fianlimab 1600mg intravenously

Arm 2

cemiplimab + REGN7075 DRUG

Cemiplimab 350mg + REGN7075 2700mg intravenously

Arm 3

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.

Also known as: Signatera, Other

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• All patients must have had a complete (R0) resection of their primary tumor and oligometastatic disease if present AND at least 3 months of a standard systemic chemotherapy regimen (e.g., FOLFOX or CAPOX or fluoropyrimidine monotherapy). This includes either adjuvant chemotherapy for colon cancer or perioperative (adjuvant or neoadjuvant) chemotherapy for rectal cancer or oligometastatic colon or rectal cancer. Chemoradiotherapy for rectal cancer (as a component of curative treatment) is acceptable. NOTE: Patients who achieve a clinical complete response and opt for a non-operative approach to their primary tumor management are not eligible.
• 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

You may not qualify if:

• Colon cancer other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid.
• Patients with MSI-high (dMMR) tumors.
• Use and/or receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, monoclonal anti-bodies) or radiation therapy within 4 weeks prior to receiving first dose of study therapy or associated with immune-mediated adverse events (imAEs) that were Grade ≥1 within 90 days prior to the first dose of study therapy or associated with toxicity that resulted in discontinuation of the immune-modulating agent.
• History of active or latent tuberculosis (TB) infection. If the presence of TB (active or latent) is established, then treatment for TB must be completed according to local guidelines prior to the screening.
• Active untreated or uncontrolled systemic fungal, bacterial, or viral infections, or active infection requiring systemic anti-infectious therapy.
• Patients will be excluded if they are on systemic steroid therapy that cannot be discontinued (except for the use of prednisone or equivalent \<0.125mg/kg/day as replacement therapy). Inhaled or topical steroids are permitted.
• Receipt of live attenuated vaccination within 30 days prior to study entry.
• Known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCB) infections.
• Note: Patients with a history of hepatitis C virus (HCV) infection must have been treated and with confirmation of cure, can be eligible.
• History of allogeneic organ or bone marrow transplantation.
• Any of the following cardiovascular conditions:
• Documented NYHA Class II, III or IV congestive heart failure,
• History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to starting study treatment
• Transient ischemic attack (TIA) or stroke within 1 year.
• History of myocarditis

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• Regeneron Pharmaceuticals: collaborator

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Department of Site and Study Management (DSSM)

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: July 10, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 10, 2025

Record last verified: 2025-06