Study on Ivonescimab Before Surgery for Treating Removable Stage II-IV Head and Neck Cancer

Inclusion Criteria

• Must be at least 18 years old.
• Have a PD-L1 combined positive score (CPS) of 1 or higher.
• Have advanced stage mucosal head and neck squamous cell carcinoma (HNSCC) that is typically treated with surgery.
• The primary tumor must be accessible for a new biopsy or have available stored tissue samples.
• Be in good overall health with an ECOG performance status of 0 or 1.
• Have adequate blood cell counts and organ function as determined by specific blood tests.
• Women of childbearing age must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after the last dose.
• Men must agree to use condoms and ensure their partners use effective contraception during the study and for 90 days after the last dose.
• Be able to understand and sign a written informed consent.
• Be considered suitable for the trial by medical professionals at the University of Michigan.

Exclusion Criteria

• Have had prior radiation therapy for the current head and neck cancer.
• Have had a neck dissection.
• Have had major surgery or serious injury within 4 weeks before joining the study.
• Have a history of bleeding disorders or significant bleeding within 4 weeks before joining the study.
• Have nasal bleeding graded as 2 or higher within 14 days before joining the study.
• Are using blood thinners or anti-platelet drugs that are not stable before joining the study.
• Require corticosteroid therapy above a certain dose within 14 days of starting the study drug.
• Have an active autoimmune disease requiring treatment within the last 5 years, with some exceptions.
• Have symptomatic brain metastases or other specific brain conditions.
• Have received a solid organ or stem cell transplant.
• Have active hepatitis B or C infections.
• Have known allergies to the study drug or its components.
• Are breastfeeding or plan to breastfeed during the study.
• Have major blood vessel issues that increase bleeding risk.
• Have received a live vaccine within 4 weeks before joining the study.
• Have a history of certain lung diseases or severe lung conditions.
• Have pre-existing nerve damage of a certain severity.
• Have a history of severe gastrointestinal issues within 6 months before joining the study.
• Have uncontrolled chronic obstructive pulmonary disease (COPD) within 4 weeks before joining the study.
• Have a history of gastrointestinal perforation or obstruction within 6 months before joining the study.
• Have uncontrolled HIV infection.
• Have active cardiovascular disease, including recent heart attacks or severe heart conditions.
• Have uncontrolled high blood pressure.
• Have heart failure of a certain severity.
• Have uncontrolled illnesses, including severe infections or diabetes, or psychiatric conditions that would interfere with the study.