Clinical Trials | A022102: Testing the addition of a third chemotherapy drug to the usual combination of two chemotherapy drugs for metastatic gastroesophageal adenocarcinoma

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Metastatic HER2-Negative Gastroesophageal Adenocarcinoma. The purpose of this study is to compare the usual treatment alone to adding a third chemotherapy drug called irinotecan to the usual treatment. The addition of irinotecan to the usual treatment could shrink your cancer and extend your life, but it could also cause side effects. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the treatment with mFOLFIRINOX, the three-drug chemotherapy, increases the life of patients by 6 months or more compared to the usual approach with FOLFOX, the two-drug chemotherapy. This chemotherapy drug, irinotecan, is already approved by the FDA for use in stomach and esophagus cancer, but most of the time it is not used until FOLFOX, the standard two-drug chemotherapy, stops working. This study has 2 study groups. Group 1 will receive mFOLFIRINOX, the three-drug chemotherapy, and Group 2 will receive mFOLFIRINOX, the three-drug chemotherapy. You will be assigned to one of the groups through a process called “randomization” which means that your doctor will not choose and you cannot choose which study arm you are in. You will have 50% chance of being in Group 1 or Group 2. With either treatment regimen, you may also receive nivolumab in addition to the chemotherapy. If your tumor has PD-L1 composite positive score (CPS) = 5, you will receive nivolumab. If your tumor has CPS<5, you may receive nivolumab at your doctor’s discretion, unless there are contraindications. The study involves receiving the study 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 take part and are deemed eligible for participation, you will receive the study drug treatment on day 1 of each cycle (every 14 days) until your disease stops responding to treatment or until you develop toxicities that you cannot tolerate. After you finish your treatment, your doctor will continue to watch you for side effects and follow your condition. If you stop treatment due to toxicities or because your disease stopped responding, your doctor will follow you by clinic visits until your disease progresses and then will follow up with you either in clinic or by phone every 6 months for up to 3 years from when you started the study. You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your cancer. Additional information can be found here: https://www.clinicaltrials.gov/study/NCT05677490 [email protected]