The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with BRAF-mutated colon cancer for a research study. The purpose of this study is to compare the usual treatment for your cancer to treatment with the study drugs, encorafenib and cetuximab. The combination of encorafenib and cetuximab could reduce the chances of your cancer returning. Encorafenib and cetuximab have already been approved by the FDA for use in other cancers, however this targeted therapy drug combination is considered investigational for this study. There are two groups in the study: Group 1 will receive the study drugs, and Group 2 will receive the usual treatment. If you participate you will be randomly assigned to one of the groups.
The study involves receiving the investigational drug, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging of your tumor, and talking to the study doctor. If you are in Group 1, you will get the combination of study drugs, encorafenib and cetuximab. You will get encorafenib as a capsule you take by mouth once a day on Days 1-28 and cetuximab through a vein in the arm on Days 1 and 15 of each cycle. Each cycle lasts 28 days. This study has 6 cycles. If you are in Group 2 you will get the usual approach for this type of cancer, which is observation. Your doctor will closely follow your condition at each clinic visit. You will be seen in clinic every three months. Each cycle lasts 28 days. This study will last approximately 6 months.
If you are in Group 1 the investigational drug, encorafenib or cetuximab, will be provided by the study at no cost to you. For both groups, all additional procedures required by the study, 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://www.clinicaltrials.gov/study/NCT05710406
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