Phase II Study Evaluating Cemiplimab Alone or Combined with Fianlimab or REGN7075 in Adults With Colorectal Cancer After Surgery and Chemotherapy

What this Trial Is About

Researchers are evaluating if immunotherapies alone or combined with other drugs can delay or prevent colorectal cancer from returning in patients who test positive for circulating tumor DNA ctDNA after their treatment. The study focuses on patients with colorectal cancer who have minimal residual disease following surgery and chemotherapy. The immunotherapies being studied are cemiplimab, fianlimab, and REGN7075, which work by activating the immune system to target and destroy cancer cells. Participants will receive one of three treatments cemiplimab alone, cemiplimab combined with fianlimab, or cemiplimab combined with REGN7075. Treatments are given intravenously with specific dosing amounts e.g., cemiplimab 350 mg. Eligible patients must have confirmed ctDNA positivity from commercial assays and will have confirmation via a special trial assay. Treatment starts after enrollment, with patients assigned to one of the treatment groups in a parallel design. During the study, participants will have regular assessments including ctDNA testing to monitor clearance and sustainability of clearance over periods ranging from 12 weeks up to 3 years. Researchers will also track recurrence-free survival and safety, including monitoring for toxicities during the treatment and up to 60 days after. Blood tests and imaging will be used to ensure patients meet criteria and to evaluate treatment effects. The total participation may last several years, with ongoing follow-up to observe outcomes.

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)