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.
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).
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.
Parallel
Cemiplimab
DrugCemiplimab 350mg intravenously
cemiplimab plus fianlimab
DrugCemiplimab 350mg + Fianlimab 1600mg intravenously
cemiplimab + REGN7075
DrugCemiplimab 350mg + REGN7075 2700mg intravenously
ctDNA testing
Other interventionEligible 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.
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
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.
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.
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.
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.
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NSABP Foundation Inc
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
