RecruitingPhase 2NCT07094685

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


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

28 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called ivonescimab — a new type of immunotherapy that combines two cancer-fighting mechanisms into one antibody — given before surgery in people with head and neck cancer that can still be removed surgically. The goal is to see whether this treatment can shrink tumors before surgery and improve outcomes. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with advanced head and neck cancer (squamous cell carcinoma, stage II–IV) that is recommended for surgery as standard care - Your tumor tests positive for PD-L1 (a protein linked to immune checkpoint activity) - You are in generally good physical health (ECOG 0 or 1) - Your blood counts, liver, and kidney function meet the required thresholds **You may NOT be eligible if...** - You have previously received radiation therapy to the area or had prior neck dissection for this cancer - You have significant bleeding tendencies or are on therapeutic blood thinners that are not stable - You have an active autoimmune disease that has required treatment in the past 5 years - You have active hepatitis B or C, or uncontrolled HIV - You have had a heart attack, stroke, or blood clot in the past 12 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Undergo surgical dissection


Locations(1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

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NCT07094685


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