NCT06109467

Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer

A Phase II Study Of Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Overexpressing Gastroesophageal Cancers

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• GastroEsophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Neratinib	All participants will take 240mg neratinib by mouth every day beginning cycle 1 day 1.
DRUG	Trastuzumab	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.
DRUG	Oxaliplatin	All participants will receive 85mg Oxaliplatin by IV infusion day 1 of each 2 week cycle.
DRUG	5-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)
DRUG	Pembrolizumab	All participants will receive 400mg Pembrolizumab by IV infusion day 1 of every 3rd 2 week cycle.

Timeline

• Start date: 2024-01-12
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2023-10-31
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study