Clinical Trials | A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer

The University of Virginia Comprehensive Cancer Center is enrolling adults ages 18 and over with Locally Advanced Unresectable or Metastatic Colorectal Cancer for a clinical trial. The purpose of this research is to learn about the tolerability and efficacy when the experimental drug MK-1084 used in combination with standard treatment, in people who have colorectal cancer (CRC) that has spread to other parts of the body and has a gene mutation called KRAS G12C. MK-1084 is experimental which means it is not approved when given alone or in combination with any other treatments. The trial will have 2 groups: Group 1 will get MK-1084 with mFOLFOX6 and cetuximab. Group 2 will get mFOLFOX6 with or without bevacizumab. A computer will decide which group you are put in. You have an equal chance of being put in either group. You, your trial doctor, and the trial staff will know which group you are in and what trial drugs you are getting. Everyone in this trial will receive the investigational trial drug and visit the trial site on a regular schedule. These trial visits will , include exams, laboratory tests, and procedures such as having your blood drawn, and talking to the trial doctor. We expect that your taking part in this research will last approximately 3 years, depending on your health and how well you tolerate the trial drugs. There will be a screening period of up to 42 days, a study treatment period of approximately 1.5 years, and a follow-up period after the end of treatment for approximately 1.5 years. The Screening Phase will last about 1 month. During this time, you will visit the site 1 or more times. If you can be in the trial, the next step is the Treatment Phase. You will be in the Treatment Phase as long as your cancer does not get worse and you tolerate the trial drugs. You will visit the trial site about every 2 weeks as long as you are getting the trial drugs. If you get MK-1084, you will have 2 extra visits during your first month of treatment. After you stop getting the trial drugs, you will enter the Follow-up Phase. If you stop getting the trial drugs because your cancer worsens, you will have about 1 or 2 follow-up visits after you stop getting the trial drugs. If you stop getting the trial drugs for another reason, you will have about 1 or 2 follow-up visits after you stop getting the trial drugs. You will then continue to visit the trial site about once every 6 or 12 weeks, depending on how long you have been in the trial. After you have completed your follow-up visits, the trial doctor or staff will contact you about every 12 weeks, or more frequently, to check on your health. The investigational study drugs, MK-1084, Cetuximab, and 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, imaging, and visits to the study center, are provided to you at no cost. You may also be reimbursed for study related travel expenses. Additional information can be found here: https://clinicaltrials.gov/study/NCT06997497 [email protected]