Actively Recruiting
A Phase II Study Evaluating Cemiplimab Alone or With Fianlimab or REGN7075 in Patients With Minimal Residual Colorectal Cancer After Surgery and Chemotherapy
Led by NSABP Foundation Inc · Updated on 2026-05-15
79
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
Sponsors
N
NSABP Foundation Inc
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether immunotherapy drugs alone or combined with other treatments can delay or prevent the return of colorectal cancer in patients who test positive for circulating tumor DNA (ctDNA) after their initial treatment. The study focuses on patients with minimal residual disease following surgery and chemotherapy. The immunotherapies being studied include cemiplimab, fianlimab, and REGN7075, which stimulate the immune system to target cancer cells. Participants receive one of three treatments: cemiplimab alone, cemiplimab combined with fianlimab, or cemiplimab combined with REGN7075. These drugs are given intravenously at specified doses. Before starting treatment, patients must have confirmed ctDNA positivity via a specialized assay, although treatment may begin while awaiting confirmation. The study is non-randomized and does not use masking. During the study, participants will be closely monitored through blood tests to measure ctDNA clearance at intervals up to three years. Researchers will assess recurrence-free survival and safety, including adverse events, over approximately 14 months of therapy and follow-up. The main outcome is clearance of ctDNA within 12 weeks, with additional monitoring of long-term ctDNA status and patient survival. Participants will undergo routine scans and lab tests as part of their assessments.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before starting study procedures
- Age 18 years or older
- ECOG performance status of 0 or 1
- Confirmed stage II or III colon or rectal cancer, or oligometastatic stage IV colorectal adenocarcinoma
- No evidence of metastatic disease by CT scan at enrollment
- Complete surgical removal (R0) of primary tumor and any oligometastatic disease
- At least 3 months of standard chemotherapy completed
- Positive circulating tumor DNA test within 2 to 12 weeks after finishing all curative therapy
- Tumor shows microsatellite stability or proficient mismatch repair
- Adequate blood counts and organ function within 28 days prior to study entry
- No evidence of opportunistic infections
- Negative pregnancy test for those of childbearing potential
- Agreement to use effective contraception during and for 6 months after treatment
You will not qualify if you...
- Colon cancer types other than adenocarcinoma (e.g., sarcoma, lymphoma, carcinoid)
- Tumors with high microsatellite instability (MSI-high) or deficient mismatch repair
- Recent anti-cancer or radiation therapy within 4 weeks before study therapy
- Active or latent tuberculosis infection not fully treated
- Active uncontrolled infections requiring systemic treatment
- Systemic autoimmune disease needing immunosuppressive therapy, except certain mild autoimmune conditions
- Use of systemic steroids that cannot be discontinued (except low-dose replacement therapy)
- Live attenuated vaccine within 30 days before study entry
- Active hepatitis B or C infection (treated HCV patients with confirmed cure allowed)
- History of organ or bone marrow transplant
- Certain significant cardiovascular diseases or recent cardiac events
- Active inflammatory bowel disease
- Major surgery within 28 days before study start
- Other recent or active cancers unless disease-free and treated as specified
- Psychiatric or addictive disorders interfering with study participation
- Pregnancy or breastfeeding at study entry
- Use of investigational agents within 28 days prior to treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive cemiplimab monotherapy or cemiplimab combined with fianlimab or REGN7075 intravenously.
Weekly visits for up to 12 weeks
Duration - Up to approximately 13 months
Participants are monitored for safety, toxicity, and recurrence after treatment ends.
Approximately monthly visits up to 13 months
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
Research Team
D
Department of Site and Study Management (DSSM)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here