A Phase II Study of Pembrolizumab Immunotherapy plus Standard Therapy for Metastatic HER2-Positive Esophagogastric Cancer

Full Title

Phase II Trial of Pembrolizumab in Combination with Trastuzumab, Capecitabine/Cisplatin in First Line Stage IV HER2-positive Metastatic Esophagogastric (EG) Cancer

Purpose

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 other types of 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).

Eligibility

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.

For more information about this study and to inquire about eligibility, please contact Dr. Yelena Janjigian at 646-888-4186.

Protocol

16-937

Phase

II

Investigator

Co-Investigators