Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Prior treatment with a PD-1 or PD-L1 inhibitor is exclusionary unless this therapy was completed > 6 months prior to the time of enrollment as part of adjuvant therapy.
Major surgical procedures or serious trauma within 4 weeks prior to enrolment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to randomization.
Participants who have not recovered from adverse events due to prior adjuvant anti-cancer therapy except for alopecia or peripheral neuropathy grade 1 or less.
Participants who are receiving any other investigational agents for this condition are not eligible.
Trial design
Treatments tested in this trial
- Ivonescimab
- 5-Fluorouracil
- Oxaliplatin
- Leucovorin
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Summit Therapeutics
Collaborator
Source ClinicalTrials.gov