A Phase II study of chemotherapy and immune checkpoint blockade with Pembrolizumab in the perioperative and maintenance treatment of locoregional gastric or GE junction adenocarcinom

Protocol: 
AAAQ9871
Phase: 
II

A Phase II study of chemotherapy and immune checkpoint blockade with Pembrolizumab in the perioperative and maintenance treatment of locoregional gastric or GE junction adenocarcinom

This is a multi-center Phase 2 trial evaluating the addition of immune therapy to standard chemotherapy for localized gastric cancer. The current treatment for localized gastric cancer is to have chemotherapy and surgery, usually the chemotherapy is given before and after surgery. However, despite surgery the cancer may return in many people. The purpose of this study is to determine if adding immune therapy to chemotherapy will increase the likelihood of eliminating the cancer and preventing the tumor from returning. The experimental therapy, pembrolizumab, works by activating the immune system through modification of immune checkpoints. In this study, we will utilize pembrolizumab both with chemotherapy and for up to 1 year after surgery as maintenance therapy. We will monitor subjects to determine if the combination therapy is safe and if it is effective in preventing tumors from recurring.

Are you Eligible? (Inclusion Criteria)

- Locally advanced gastric or GE junction adenocarcinoma with plan for
curative surgery after chemotherapy
- Ability to provide biopsy sample or undergo a new biopsy at study entry
- Ability to participate in up to 12 months of maintenance therapy after
surgery
- Adequate kidney and liver function

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States