A Phase II Study of Pembrolizumab Immunotherapy plus Trastuzumab or Trastuzumab Alone after Surgery in Patients with Esophagogastric Tumors

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Full Title

A Randomized Phase II Double-Blind Trial Of Adjuvant Pembrolizumab/Trastuzumab Or Trastuzumab In HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection

Purpose

Having tumor DNA circulating in the blood shows that a patient may have a higher risk of a cancer coming back after surgery. In this study, researchers are comparing treatment with pembrolizumab immunotherapy plus trastuzumab to trastuzumab alone in patients with cancers of the esophagus and stomach (esophagogastric cancers) who have evidence of circulating tumor DNA after cancer surgery.

Pembrolizumab takes the brakes off the immune response by targeting a protein called PD-1, enabling the immune system to detect and destroy cancer cells. Trastuzumab is already used to treat esophagogastric cancers that contain high levels of a protein called HER2.

Patients in this study will be randomly assigned to receive pembrolizumab plus trastuzumab or trastuzumab alone. Both drugs are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have esophageal, stomach, or gastroesophageal junction cancer that was surgically removed.
  • Patients must have circulating tumor DNA within 8 months of completing therapy.
  • At least 2 weeks must pass between the completion of previous treatment and receipt of the study treatment.
  • 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

20-158

Phase

II

Investigator

Co-Investigators