A Phase II Study Of Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Overexpressing Gastroesophageal Cancers
H. Lee Moffitt Cancer Center and Research Institute
Summary
The purpose of the study is to test the effects, both good and bad, of the research study drug Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX chemotherapy. This study will also look at the safety of Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX in HER2 overexpressing Gastroesophageal cancers.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have pathologically or cytologically confirmed esophageal, gastric or gastroesophageal junction (GEJ) adenocarcinoma by the enrolling institution. * Patients must have esophageal, gastric or GEJ adenocarcinoma with HER2 overexpression and/oramplification as determined by immunohistochemistry (IHC 3+) or fluorescent in situ hybridization (FISH+ as defined as HER2:CEP17 ratio ≥2.0 if IHC 2+). No central testing will be required. The testing can be performed on archival tissue that is less than 6 months old. If archival tissue is more than 6 months old, a new…
Interventions
- DrugNeratinib
All participants will take 240mg neratinib by mouth every day beginning cycle 1 day 1.
- DrugTrastuzumab
All participants will receive standard dosing (6mg/kg loading dose, 4 mg/kg subsequent doses) of Trastuzumab by IV infusion day 1 of each 2 week cycle.
- DrugOxaliplatin
All participants will receive 85mg Oxaliplatin by IV infusion day 1 of each 2 week cycle.
- Drug5-Fluorouracil + leucovorin
All participants will receive 400 mg/m\^2 5-Fluorouracil (5FU)+ 400 mg/m\^2 leucovorin day 1 of each 2 week cycle; 5FU continuous infusions on days 1 and 2 of each 2 week cycle. (5FU + leucovorin may be eliminated from regimen per PI discretion)
- DrugPembrolizumab
All participants will receive 400mg Pembrolizumab by IV infusion day 1 of every 3rd 2 week cycle.
Location
- Moffitt Cancer CenterTampa, Florida