Clinical Trials | 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)

The UVA Comprehensive Cancer Center seeks adults ages 18 and over with Colorectal Cancer with Minimal Residual Disease Following Definitive Surgery and Chemotherapy. The study is being done determine if using immunotherapies alone or in combination with other drugs will delay or prevent colorectal cancer from coming back in participants with colorectal cancer who are ctDNA-positive (DNA of your tumor cells found in your bloodstream through a previous test). 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. These drugs are considered investigational because they have not been approved by the FDA for these uses. The purpose of this study is to monitor how effective the study drugs are in delaying or stopping colorectal cancer from coming back by checking your blood for ctDNA at different timepoints. This testing, using the Signatera™ test by Natera, Inc., is considered investigational in this study. Another purpose of the study is to learn more about certain characteristics of colorectal cancer tumors, this study includes research tests using samples from your tumor and blood samples. The study involves receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, ctDNA testing and procedures such as having your blood drawn, imaging, and talking to the study doctor. If you participate in the study, you will be assigned to receive one of three possible study treatments called study arms 1, 2, and 3.The study doctor will tell you which study arm you are assigned to. • Arm 1: Cemiplimab only o Through a vein (IV) Day 1 of every 3-week cycle for up to a total of 17 cycles (1 year) • Arm 2: Cemiplimab and Fianlimab o Through a vein (IV) Day 1 of every 3-week cycle for up to a total of 17 cycles (1 year) • Arm 3: REGN7075 and cemiplimab o REGN7075 through a vein (IV) once a week for 3 weeks, and then both REGN7075 and cemiplimab through a vein (IV) Day 1 of every 3-week cycle for up to a total of 17 cycles (1 year). Participants who agree to join the FC-13 study may be in the study for approximately 18 months, unless your colorectal cancer recurs, or you withdraw from the study. The study drugs, cemiplimab, fianlimab, and REGN7075, will be provided by the sponsor at no cost to you. All additional study procedures that are beyond your standard medical care, including laboratory tests, physical examinations, and visits to the study center, are provided to you at no charge. Additional information can be found here: https://clinicaltrials.gov/study/NCT07058012 [email protected]