A Single-Arm, Multicenter Phase 2 Study of Neoadjuvant Pembrolizumab With Trastuzumab and Chemotherapy in Resectable HER2+ Esophagogastric Tumors
Memorial Sloan Kettering Cancer Center
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPembrolizumab
Pembrolizumab will be administered on an every 3-week dosing schedule
- DrugTrastuzumab
Trastuzumab will be administered on an every 3-week dosing schedule
- DrugOxaliplatin
Oxaliplatin every 3 weeks, +/-7 days
- DrugCapecitabine
Capecitabine twice daily on days 1 to 14 every 3 weeks or 5-FU on days 1 to 5 every 3 weeks
- Drug5-Fluorouracil
5-Fluorouracil administered as a 24 hour IV continuous infusion once every 2 weeks
- DrugDocetaxel
Docetaxel administered intravenously once every 2 weeks.
Locations (10)
- Massachusetts General Hospital (Data Collection Only)Boston, Massachusetts
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, New York