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