Full TitlePhase II trial of pembrolizumab in combination with trastuzumab, fluoropyrimidine, and platinum in first line Stage IV HER2-positive metastatic esophagogastric (EG) cancer
Trastuzumab is a drug that targets a protein called HER2, which is overproduced in some esophageal and stomach (esophagogastric) cancers. Other drugs commonly used to treat advanced esophagogastric cancers are cisplatin and capecitabine. In this study, researchers want to see if adding the immunotherapy drug pembrolizumab to trastuzumab, cisplatin, and capecitabine treatment is safe and effective in patients with metastatic HER2-positive esophagogastric cancers.
Pembrolizumab works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. Pembrolizumab is already approved to treat several cancers; its use in this study is considered investigational. Pembrolizumab, trastuzumab, and cisplatin are given intravenously (by vein), and capecitabine is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have stage IV esophagogastric cancer and may not have received chemotherapy for metastatic cancer.
- At least 2 weeks must pass between the completion of any prior therapies and entry into the study.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.