Colo-rectal CancerPhase 2EMPIRENCT07058012
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 2 study testing Cemiplimab, cemiplimab plus fianlimab and cemiplimab + REGN7075 in people with Colo-rectal Cancer, run by NSABP Foundation Inc at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Cemiplimab, cemiplimab plus fianlimab and cemiplimab + REGN7075
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 13 sitesUnited States
- Study dates
- 17 Apr 2026to 1 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (non-resected or non-ablated) 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 resected or ablated (radiofrequency ablation, stereotactic body radiation therapy [SBRT], microwave ablation, etc.]) 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.
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- Patients must be ctDNA-positive by an assay run in any CLIA-certified lab obtained within 2 weeks to 12 months 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.)
- Creatinine must be ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 40mL/min.
- All prior chemotherapy toxicities (excluding alopecia, amenorrhea, and peripheral neuropathy) must be less than (<) Grade 2 at the time study therapy is to begin unless AE(s) are clinically stable on supportive therapy.
- Patients must have no evidence of opportunistic infections.
- Patients of childbearing potential must have a negative pregnancy per institutional policies prior to receiving the first dose of study therapy.
- Male and female patients with reproductive potential must agree to use accepted effective methods of contraception while receiving study therapy and for at least 180 days (6 months) after the completion of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
Who cannot join
- 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.
- Current or history of systemic autoimmune disease requiring systemic immunosuppressive therapy will not be allowed. Note: the following will not be exclusionary: 1) the presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody titer or lupus anticoagulant) without associated symptoms; 2) clinical evidence of vitiligo or other forms of depigmenting illness; 3) mild autoimmunity not impacting the function of major organs (e.g., controlled Hashimoto thyroiditis, limited psoriasis), Type I diabetes.
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- 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
- Troponin T (TnT) or troponin I (TnI) > 2x institutional ULN at baseline. Patients with TnT or TnI levels between > 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are > 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on medical judgement in the patient's best interest.
- Active, documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Major surgical procedure within 28 days prior to study entry.
- Other malignancies: unless the patient is considered disease-free and has completed therapy for the malignancy greater than or equal to 36 months prior to study entry. Patients with the following cancers are eligible if diagnosed and definitively treated within the past 12 months: carcinoma in situ of the cervix, and basal cell and squamous cell carcinoma of the skin. Other in situ neoplasms will be reviewed by the Protocol Officer and/or Protocol Chair.
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
University of Maryland Greenbaum
Baltimore, Maryland, 21201
- Recruiting
University of Virginia Health
Charlottesville, Virginia, 22903
- Recruiting
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
Ballad Health Cancer Center - Kingsport
Kingsport, Tennessee, 37660
- Recruiting
Bon Secours St. Francis Medical Center
Midlothian, Virginia, 23114
- Recruiting
First Health of the Carolinas
Pinehurst, North Carolina, 28374
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
- Recruiting
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
- Recruiting
Virginia Commonwealth University - Massey
Richmond, Virginia, 23298
- Recruiting
Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, 84112
- Recruiting
Missouri Baptist
St Louis, Missouri, 63131
About this study
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
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
- Being tested
- Cemiplimab, cemiplimab plus fianlimab, cemiplimab + REGN7075, ctDNA testing
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Cemiplimab 350mg intravenously
cemiplimab plus fianlimabDrug
Cemiplimab 350mg + Fianlimab 1600mg intravenously
cemiplimab + REGN7075Drug
Cemiplimab 350mg + REGN7075 2700mg intravenously
ctDNA testingOther
Also called Signatera, 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 group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | cemiplimab Receives: Drug: Cemiplimab; Other: ctDNA testing |
| Arm 2 | Active comparator | cemiplimab plus fianlimab Receives: Drug: cemiplimab plus fianlimab; Other: ctDNA testing |
| Arm 3 | Experimental | cemiplimab plus REGN7075 Receives: Drug: cemiplimab + REGN7075; Other: ctDNA testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 12 weeks
Secondary outcomes (7)
Sustainability of clearance of ctDNA
In the subset of patients who did clear ctDNA by 12 weeks (see the primary outcome), to determine the proportion of patients that remain ctDNA-negative at 12 months from trial enrollment.
Measured: From enrollment to 12 months
Sustainability of clearance of ctDNA
In the subset of patients who did clear ctDNA by 12 weeks (see the primary outcome), to determine the proportion of patients that remain ctDNA-negative at 18 months from trial enrollment.
Measured: From enrollment to 18 months
Kinetics of ctDNA clearance in MRD in patients crossing over from cemiplimab monotherapy
In the subset of patients who cross over from the cemiplimab monotherapy arm, to determine the proportion of patients who convert to ctDNA negative at 12 weeks after crossover, and at 12 and 18 months after study entry.
Measured: From crossover to 18 months after enrollment
MRD Response by quantitative ctDNA
To determine the percentage of patients whose MRD show a response to the trial regimen, including both clearance of ctDNA and partial ctDNA quantitative response defined as decrease in the burden of quantitative ctDNA from baseline.
Measured: From enrollment up to 3 years
Recurrence-free survival (RFS)
To determine time to imaging recurrence following initiation of study therapy through follow-up
Measured: From enrollment up to 3 years
Safety [Will be performed on the ITT population]
To describe the adverse events observed for each arm of the study according to the CTCAE version 5.0
Measured: During study therapy and up to 60 days post therapy, approximately up to 425 days
Number of participants with Toxicity [Will be performed on the ITT population]
To describe the reasons for early termination of therapy
Measured: During study therapy and up to 60 days post therapy, approximately up to 425 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start17 Apr 2026
- Primary completion17 Apr 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058012
- Sponsor's protocol ID
- NSABP FC-13
- Acronym
- EMPIRE
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Saeed A, Yothers G, Puhalla SL, Tojjari A, Rastogi P, Freeman TJ, Mathias MD, Seebach FA, Wolmark N, George TJ. EMPIRE (NSABP FC-13): a biomarker-driven phase II platform trial evaluating cemiplimab-based immunotherapy in microsatellite-stable colorectal cancer with ctDNA-defined minimal residual disease. Future Oncol. 2026 Jul;22(16):1925-1933. doi: 10.1080/14796694.2026.2688569. Epub 2026 Jun 25.
PubMed 42345857
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07058012
- Acronym / sponsor ID
- EMPIRE / NSABP FC-13
- Conditions
- Colo-rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- NSABP Foundation IncResearch network
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 17 Apr 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Cemiplimab, Other: ctDNA testingcemiplimab |
| Arm 2 | Active comparator | Drug: cemiplimab plus fianlimab, Other: ctDNA testingcemiplimab plus fianlimab |
| Arm 3 | Experimental | Drug: cemiplimab + REGN7075, Other: ctDNA testingcemiplimab plus REGN7075 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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 (non-resected or non-ablated) metastatic disease including assessment of chest, abdomen, and pelvis at the time of study enrollment
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabCemiplimab 350mg intravenously | Drug | Arm 1 |
| cemiplimab plus fianlimabCemiplimab 350mg + Fianlimab 1600mg intravenously | Drug | Arm 2 |
| cemiplimab + REGN7075Cemiplimab 350mg + REGN7075 2700mg intravenously | Drug | Arm 3 |
| ctDNA testingAlso: Signatera, OtherEligible 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. | Other | Arm 1, Arm 2, Arm 3 |
Primary outcome
Clearance of cDNA
Time frame: From enrollment to 12 weeks
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
7 secondary outcomes
Sustainability of clearance of ctDNA
Time frame: From enrollment to 12 months
Sustainability of clearance of ctDNA
Time frame: From enrollment to 18 months
Kinetics of ctDNA clearance in MRD in patients crossing over from cemiplimab monotherapy
Time frame: From crossover to 18 months after enrollment
MRD Response by quantitative ctDNA
Time frame: From enrollment up to 3 years
Recurrence-free survival (RFS)
Time frame: From enrollment up to 3 years
Safety [Will be performed on the ITT population]
Time frame: During study therapy and up to 60 days post therapy, approximately up to 425 days
Number of participants with Toxicity [Will be performed on the ITT population]
Time frame: During study therapy and up to 60 days post therapy, approximately up to 425 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 42345857Saeed A, Yothers G, Puhalla SL, Tojjari A, Rastogi P, Freeman TJ, Mathias MD, Seebach FA, Wolmark N, George TJ. EMPIRE (NSABP FC-13): a biomarker-driven phase II platform trial evaluating cemiplimab-based immunotherapy in microsatellite-stable colorectal cancer with ctDNA-defined minimal residual disease. Future Oncol. 2026 Jul;22(16):1925-1933. doi: 10.1080/14796694.2026.2688569. Epub 2026 Jun 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab, cemiplimab plus fianlimab and cemiplimab + REGN7075 in people with Colo-rectal Cancer, run by NSABP Foundation Inc at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Department of Site and Study Management (DSSM) (1-800-270-3165, industry.trials@nsabp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of cDNA (time frame: From enrollment to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07058012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.