Actively Recruiting
Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-09
36
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
P
Puma Biotechnology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma
- Cancer must show HER2 overexpression or amplification by specific testing
- No prior chemotherapy for stage IV disease or treatment-na�ve for metastatic disease
- Prior adjuvant therapy allowed if more than 6 months have passed since completion
- Prior maintenance nivolumab allowed if last dose was more than 3 months prior
- Measurable disease according to RECIST v1.1
- Normal or borderline heart function with LVEF 6gt;= 53% or 40-52% after consultation
- ECOG performance status 0 or 1
- Adequate organ function per protocol
- Negative pregnancy test for women of childbearing potential
- Use of effective contraception during and 120 days after treatment for women and men
- Treated brain metastases allowed if stable for 4-6 weeks post-treatment
- Ability and willingness to provide informed consent
You will not qualify if you...
- Participation in another investigational study or use of investigational treatment within 4 weeks
- Prior chemotherapy, targeted therapy, or immunotherapy for metastatic disease before study start
- Not recovered from adverse events of prior treatments except alopecia or hypothyroidism
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic therapy within past 2 years
- Immunodeficiency or chronic steroid use above prednisone 10 mg/day equivalent
- History or current non-infectious pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Baseline neuropathy greater than grade 1
- Any condition or abnormality interfering with trial participation or results
- Psychiatric or substance abuse disorders affecting cooperation
- Pregnancy, breastfeeding, or intending to conceive or father children during study and 120 days after
- COVID-19 infection within 90 days or unresolved related symptoms
- Significant cardiac disease including congestive heart failure NYHA > Class II, active coronary artery disease, significant arrhythmias, unstable angina, recent myocardial infarction, or prolonged QTc interval
- Significant chronic gastrointestinal disorder with diarrhea as a major symptom
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
E
Erin Mcewan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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