Phase II Study of Ivonescimab Given Before Surgery for Adults with Resectable Stage II-IV Head and Neck Cancer

What this Trial Is About

Researchers are evaluating how well ivonescimab works before surgery in patients with stage II-IV head and neck cancer that can be removed by surgery. Ivonescimab is a bispecific monoclonal antibody designed to target specific molecules related to tumor growth and spread. This Phase II trial explores its potential role in treating advanced head and neck squamous cell carcinoma where surgery is planned as part of routine care. Participants will receive ivonescimab through an intravenous infusion over 60 to 120 minutes on day 1 of each 21-day cycle, for up to three cycles if there is no disease progression or unacceptable side effects. After completing ivonescimab treatment, surgery to remove the tumor will be performed 4 to 8 weeks later. Various procedures such as PET-CT scans, biopsies, CT or MRI scans, and blood sample collections will be done before and during the trial to monitor the disease and treatment effects. During the study, participants will undergo imaging and biopsy procedures at screening and may have repeated scans and blood collections throughout. Researchers will measure outcomes including the major pathologic response rate, toxicities related to ivonescimab, overall response rate using standard criteria, and pathologic complete response rate over a follow-up period of up to 36 months. Safety and treatment impact will be carefully monitored throughout the study duration, which ends in November 2030.

Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer