A Phase II Study Evaluating Neoadjuvant Ivonescimab for Resectable Head and Neck Cancer
University of Michigan Rogel Cancer Center
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * At least 18 years of age * PD-L1 combined positive score (CPS) \>= 1 * Histologically documented advanced stage mucosal HNSCC (stage II-IV), for which surgery would be recommended in routine clinical practice * Primary tumor is amenable to fresh biopsy or availability of archival fresh frozen primary tissue * Eastern Cooperative Oncology Group (ECOG) 0-1 * Absolute neutrophil count \> 1500 cells/uL * Platelet count \>= 100,000/uL * Hemoglobin \>= 9.0 g/dL (without transfusion within 14 days prior to cycle 1, day 1) * Total bilirubin =\< 1.5 x institutional upper limit of…
Interventions
- ProcedureBiopsy Procedure
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo PET-CT and CT scan
- BiologicalIvonescimab
Given IV
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePositron Emission Tomography
Undergo PET-CT scan
- ProcedureSurgical Procedure
Location
- University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan