Title: A Phase II Study of Chemotherapy and Immune Checkpoint Blockade With Pembrolizumab in the Perioperative and Maintenance Treatment of Locoregional Gastric or GE Junction Adenocarcinoma1

Principal Investigators: Paul E Oberstein, MD, Columbia University

Description: For this open-label, phase 2 study, researchers are investigating the efficacy of pembrolizumab immunotherapy plus chemotherapy as perioperative treatment for patients with gastric cancer or adenocarcinoma of the gastroesophageal junction.

All patients will receive 3 cycles of an investigator’s choice of standard chemotherapy regimen plus pembrolizumab before and after surgery, with 1 additional cycle of pembrolizumab prior to surgery. Patients will then receive 14 extra doses of pembrolizumab during 12 months of maintenance therapy post-surgery.

The primary outcome measure is 2-year disease-free survival. Secondary outcome measures are pathologic complete response rate and disease-free survival evaluated over 34 months, as well as overall survival and overall response rate evaluated over 5 years.

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For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02918162.

Status: This study is open and recruiting patients as of October 25, 2017.

This study is sponsored by Columbia University.

Reference

  1. Clinicaltrials.gov. Perioperative chemo and pembrolizumab in gastric cancer. NCT02918162. https://clinicaltrials.gov/ct2/show/NCT02918162. Accessed October 25, 2017.