Memorial Sloan Kettering Cancer Center
The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.
Eligible patients will receive 8 peri-operative cycles of pembrolizumab and trastuzumab with chemotherapy (fluoropyrimidine/oxaliplatin doublet for patients initially enrolled and subsequently FLOT \[5-fluorouracil, oxaliplatin and docetaxel\] followed by pembrolizumab and trastuzumab maintenance to complete 1 total year of therapy.
Inclusion Criteria: * Age 18 years or older at time of signing informed consent. * ECOG performance status 0-1. * HER2+ esophageal, GEJ, or gastric adenocarcinoma biopsy or resection specimen as defined by local HER2 IHC3+ or IHC 2+/FISH\>2.0 expression. * Complete surgical resection of the primary tumor must be achievable * Demonstrate adequate organ function as defined in Table 1. Table 1 - Organ Function Requirements for Eligibility Hematological * Absolute neutrophil count (ANC): ≥1,500 /mcL * Platelets: ≥100,000 / mcL * Hemoglobin: ≥8 g/dL Renal * Creatinine clearance: ≥ 50 mL/minute H…
Pembrolizumab will be administered on an every 3-week dosing schedule
Trastuzumab will be administered on an every 3-week dosing schedule
Oxaliplatin every 3 weeks, +/-7 days
Capecitabine twice daily on days 1 to 14 every 3 weeks or 5-FU on days 1 to 5 every 3 weeks
5-Fluorouracil administered as a 24 hour IV continuous infusion once every 2 weeks
Docetaxel administered intravenously once every 2 weeks.
will be collected (optionally)
will be collected (optionally)