Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA
A Single-Arm, Phase II Study of Ivonescimab in Combination With FOLFOX in Advanced HER2 Negative Gastroesophageal Adenocarcinomas
Sponsor: Massachusetts General Hospital + Summit Therapeutics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
6-month progression free survival rate
Time frame: From the start of treatment (Cycle 1, day 1) to first documented disease progression or date of death from any cause. Status at 6-months after starting treatment will be reported.
Secondary Endpoints
Incidence and Severity of Treatment-Emergent Adverse Events
Objective Response Rate
Overall Clinical Benefit
Eligibility Criteria
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 adjuvant therapy and registration. * Age ≥18 years old. Because there is no dosing or adverse event data for ivonescimab with FOLFOX in participants \<18 years of age, children are excluded from this study. * ECOG Performance status of 0-2 * Participants must meet the following organ and marrow function as defined below: 1. absolute neutrophil count ≥1,500/mcL 2. hemoglobin \> 9.0 g/dL 3. …
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →