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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06109467
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 12, 2024
Status verified
Feb 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with Neratinib with Trastuzumab, Pembrolizumb and mFOLFOX
    All patients will be treated with combination of neratinib with trastuzumab, pembrolizumab and mFOLFOX. All patients will receive standard dose 5FU/oxaliplatin/trastuzumab every 2 weeks. Pembrolizumab 400 mg intravenously will be administered once every 6 weeks. Neratinib will be dosed 240 mg orally daily

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Dae Won Kim, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
Moffitt Cancer Center· Tampa, FL

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