Clinical Trials | A Randomized, Phase III Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First-line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)

The UVA Comprehensive Cancer Center seeks adults ages 18 and over with HER2-positive Gastric Cancer. The purpose of this research is to examine the efficacy and safety of the investigational drug rilvegostomig in combination with chemotherapy and trastuzumab deruxtecan (also known as T-DXd, DS-8201a), and rilvegostomig in combination with trastuzumab and chemotherapy, compared to trastuzumab, chemotherapy and pembrolizumab in certain patients with gastric cancer. Rilvegostomig and trastuzumab deruxtecan (T-DXd) are 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 assigned to a study treatment. Randomly assigned means that whatever treatment you get will be by chance, like flipping a coin or drawing names out of a hat. You have an equal chance of being assigned to one of the following treatment groups: • Arm A: rilvegostomig, T-DXd and 5-FU/capecitabine, • Arm B: pembrolizumab, trastuzumab, cisplatin/oxaliplatin and 5-FU/capecitabine, • Arm C: rilvegostomig, trastuzumab, cisplatin/oxaliplatin and 5-FU/capecitabine. 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, you will enter the treatment period where you will receive study drugs in 3 weeks cycles. The frequency of receiving the study drug depends on which arm you are assigned to. After your last treatment is given, you will have an End of Study Treatment Visit that will occur within 7 days of stopping the study drugs. 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 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/NCT06764875 [email protected]