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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT07094685
Phase
PHASE2
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Nov 18, 2025
Status verified
Nov 2025
Primary completion
Aug 1, 2027
Completion
Nov 1, 2030

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ivonescimab)
    Patients receive ivonescimab IV over 60-120 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Then 4-8 weeks after last dose of ivonescimab, patient undergoes standard of care surgical dissection. Patients undergo PET-CT and may undergo biopsy at screening, as well as CT or MRI and collection of blood samples throughout the trial.

Primary Outcome Measure

Major pathologic response rate [ Time Frame: Up to 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109
Cancer AnswerLine
[email protected]
800-865-1125
Paul L. Swiecicki (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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