Clinical Trials | A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)

The UVA Comprehensive Cancer Center seeks adults ages 18 and over with Metastatic Colorectal Cancer. The purpose of this study is to measure the safety and effectiveness of an investigational drug ivonescimab (SMT112) combined with chemotherapy drugs compared to bevacizumab combined with chemotherapy drugs. The study drug is considered investigational because it has not been approved for sale by the United States Food and Drug Administration (FDA). If you participate in the study, you will be randomly placed in one of two groups. One group will get the ivonescimab (SMT112) with chemotherapy drugs. The other group will get bevacizumab along with chemotherapy drugs. You have a 50% chance of being placed in either study treatment group. The group you are placed in is known as a process called "randomization." This process uses a computer to assign study participants to groups in a fair way. It also makes sure the groups are balanced based on things like your type and location of cancer in colon, whether you have cancer in your liver, and where you live. Neither you nor the study doctors can choose your group or know which group you are in. The study involves receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging, and talking to the study doctor. If you choose to participate the study will consist of three parts: screening, study treatment, and follow-up. The screening period is where the study team will see if you are eligible for the study. After screening, if you are deemed eligible for participation and consent to participate in the study, you will enter the treatment period where you will receive study infusions every 2 weeks, this 2-week period is called a cycle. You will go to the clinic on the first day of each cycle for your infusions and procedures for up to 24 months. After you have your last infusion, you will have an End of Study Treatment Visit that will occur within 7 days of stopping ivonescimab (SMT112) or bevacizumab. For the follow-up period, you will be contacted by the study team every 3 months to see how you are doing. The study drugs, ivonescimab (SMT112) or bevacizumab, 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/NCT07228832 [email protected]