A Single-Arm, Phase II Study of Ivonescimab in Combination With FOLFOX in Advanced HER2 Negative Gastroesophageal Adenocarcinomas
Massachusetts General Hospital
Summary
This is a single arm, open-label, phase II trial investigating the combination of ivonescimab with standard FOLFOX chemotherapy in 1L therapy for HER2- GEA.
Description
This is a single arm, open-label, non-randomized multi-institution phase II trial of the anti-PD-1 x VEGR bispecific antibody ivonoescimab in combination with standard 5-fluorouracil (5FU) and oxaliplatin as first line therapy in patients with locally advanced unresectable or metastatic HER2 negative (HER2-) gastroesophageal adenocarcinomas. The primary hypothesis is that the combination of dual VEGF and PD-1 targeting with standard 5FU/oxaliplatin (FOLFOX) will overcome intrinsic immunotherapy resistance and increase the objective response rate (ORR) and progression free survival (PFS) in fro…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have a pathologically confirmed diagnosis of adenocarcinoma of the esophagus, gastroesophageal junction, stomach. Squamous cell tumors are excluded. Patients with locally tested HER2 positive tumors (HER2+) tumors are excluded. * Participants must have disease that can be evaluated radiographically. This includes disease that may be measurable or non-measurable as per RECIST version 1.1. * Patients may not have received prior therapy for Stage IV disease. Patients may have received prior adjuvant therapy if more than 6 months have elapsed between the end of…
Interventions
- DrugIvonescimab
Humanized immunoglobulin G1 monoclonal antibody
- Drug5-Fluorouracil
Nucleoside metabolic inhibitor
- DrugOxaliplatin
Platinum-based drug and organoplatinum complex
- DrugLeucovorin
5-formyl derivative of tetrahydrofolic acid
Locations (2)
- UCLASanta Monica, California
- Massachusetts General HospitalBoston, Massachusetts