NCT06109467 Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer
| NCT ID | NCT06109467 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Condition | GastroEsophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-01-12 |
| Primary Completion | 2028-04 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patients must have pathologically or cytologically confirmed esophageal, gastric or gastroesophageal junction (GEJ) adenocarcinoma by the enrolling institution. * Patients must have esophageal, gastric or GEJ adenocarcinoma with HER2 overexpression and/oramplification as determined by immunohistochemistry (IHC 3+) or fluorescent in situ hybridization (FISH+ as defined as HER2:CEP17 ratio ≥2.0 if IHC 2+). No central testing will be required. The testing can be performed on archival tissue that is less than 6 months old. If archival tissue is more than 6 months old, a new biopsy must be obtained to confirm HER2 status prior to enrollment. * Patients may have received no prior chemotherapy or be treatment naïve for stage IV disease. Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and expected date of treatmentstart on this study. Patients who have received ma
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