A Phase III Study of Pembrolizumab Immunotherapy plus Chemotherapy versus Placebo plus Chemotherapy as Neoadjuvant/Adjuvant Treatment for Gastric and Gastroesophageal Junction Cancers

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Full Title

A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) plus Chemotherapy (XP or FP) versus Placebo plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585) WIRB

Purpose

The purpose of this study is to see if adding the immunotherapy drug pembrolizumab to standard chemotherapy given before and after surgery is more effective than chemotherapy alone for patients with newly diagnosed cancers of the stomach (gastric cancer) and the junction between the stomach and esophagus (gastroesophageal junction or GEJ cancers). Patients in this study will be randomly assigned to receive chemotherapy and pembrolizumab before and after surgery followed by pembrolizumab only, OR chemotherapy and placebo treatment (inactive drug) before and after surgery followed by placebo only.

Pembrolizumab blocks PD-1, a protein cancer cells use to evade detection by the immune system, thereby enabling the immune system to find and kill cancer cells. It is 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 previously untreated gastric or GEJ cancer.
  • Patients may not have previously received immunotherapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Ilson at 646-888-4183.

Protocol

18-515

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators