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

NCT06109467 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-02-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Dae Won Kim, MD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2028-04-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06109467 on ClinicalTrials.gov