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

No results posted yet for this study

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

Ivonescimab

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07094685 on ClinicalTrials.gov