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

PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 12, 2024

Primary Completion Date

April 30, 2028

Study Completion Date

April 30, 2028

Conditions
GastroEsophageal CancerGastric Cancer
Interventions
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.

Trial Locations (1)

33612

RECRUITING

Moffitt Cancer Center, Tampa

All Listed Sponsors
collaborator

Puma Biotechnology, Inc.

INDUSTRY

collaborator

National Comprehensive Cancer Network

NETWORK

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER