Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer
NCT07094685 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2025-11-25
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
- PROCEDURE
-
Biopsy Procedure
Undergo biopsy
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- PROCEDURE
-
Computed Tomography
Undergo PET-CT and CT scan
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- PROCEDURE
-
Positron Emission Tomography
Undergo PET-CT scan
- PROCEDURE
-
Surgical Procedure
Undergo surgical dissection
Sponsors & Collaborators
-
Summit Therapeutics
collaborator INDUSTRY -
University of Michigan Rogel Cancer Center
lead OTHER
Principal Investigators
-
Paul L Swiecicki · University of Michigan Rogel Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-18
- Primary Completion
- 2027-08-01
- Completion
- 2030-11-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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