NCT07094685

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

A Phase II Study Evaluating Neoadjuvant Ivonescimab for Resectable Head and Neck Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests how well ivonescimab before surgery works in treating patients with stage II-IV head and neck cancer that can be removed by surgery (resectable). Ivonescimab is a bispecific monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A bispecific monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).

Conditions

• Advanced Head and Neck Squamous Cell Carcinoma
• Resectable Head and Neck Squamous Cell Carcinoma
• Stage II Head and Neck Cutaneous Squamous Cell Carcinoma
• Stage III Head and Neck Cutaneous Squamous Cell Carcinoma
• Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo PET-CT and CT scan
BIOLOGICAL	Ivonescimab	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Positron Emission Tomography	Undergo PET-CT scan
PROCEDURE	Surgical Procedure	Undergo surgical dissection

Timeline

• Start date: 2025-11-18
• Primary completion: 2027-08-01
• Completion: 2030-11-01
• First posted: 2025-07-30
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study