At a glance
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A Phase II Study of Chemotherapy and Immune Checkpoint Blockade With Pembrolizumab in the Perioperative and Maintenance Treatment of Locoregional Gastric or GE Junction Adenocarcinoma.
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab and Standard of care chemotherapy regimen for Gastric Cancer and Adenocarcinoma of the Gastroesophageal Junction. Completed, enrolled 49 participants across 4 sites.
Detailed Summary
This is a non-randomized, multi-site, open-label trial of pembrolizumab and chemotherapy in subjects with gastric or gastroesophageal (GE) junction adenocarcinoma. The purpose of this study is to determine and evaluate the efficacy of combination therapy with immune checkpoint blockade and chemotherapy used in the perioperative period in eradicating micrometastatic disease; and to compare paired tissue and serum samples (pre-treatment and post-treatment) from individually treated patients to explore the immune effects of combination therapy and predictors of response.
Study Details
Timeline
Interventions
Pembrolizumab dosed IV at 200mg every 21 days per cycle.
Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician. Example: Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.