Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07094685

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

Led by University of Michigan Rogel Cancer Center · Updated on 2025-11-25

28

Participants Needed

1

Research Sites

258 weeks

Total Duration

On this page

Sponsors

U

University of Michigan Rogel Cancer Center

Lead Sponsor

S

Summit Therapeutics

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • PD-L1 combined positive score (CPS) of 1 or higher
  • Histologically confirmed advanced stage mucosal head and neck squamous cell carcinoma (stage II-IV) suitable for surgery
  • Primary tumor accessible for fresh biopsy or availability of archival fresh frozen primary tissue
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Absolute neutrophil count greater than 1500 cells/uL
  • Platelet count of at least 100,000/uL
  • Hemoglobin level of 9.0 g/dL or higher without recent transfusion
  • Total bilirubin less than or equal to 1.5 times the institutional upper limit of normal (ULN) or up to 3 times ULN for Gilbert's disease patients
  • AST and ALT less than or equal to 2.5 times the institutional ULN
  • Creatinine less than or equal to 1.5 times the institutional ULN or adequate kidney function as measured by eGFR or creatinine clearance
  • Urine protein less than 2+ or 24-hour urine protein quantification less than 1.0 g
  • Coagulation parameters within acceptable limits unless patient is on stable therapeutic anti-coagulation
  • Negative pregnancy test for females of childbearing age
  • Agreement to use effective contraception for females and males with partners of childbearing potential during and 90 days after treatment
  • Ability to understand and sign informed consent
  • Considered a candidate for trial therapy by University of Michigan Medical Oncology and Otolaryngology providers
Not Eligible

You will not qualify if you...

  • Prior radiation therapy for current mucosal head and neck squamous cell carcinoma
  • Prior neck dissection
  • Major surgery or serious trauma within 4 weeks before enrollment; minor local procedures within 3 days before treatment
  • History of bleeding disorders or significant recent bleeding
  • Moderate or worse nasal bleeding within 14 days prior to registration
  • Unstable use of anticoagulants or anti-platelet agents
  • Use of corticosteroids over 10 mg prednisone/day within 14 days before study drug, except physiologic replacement doses
  • Active or recent autoimmune disease requiring systemic therapy within 5 years, with some exceptions
  • Symptomatic or large central nervous system metastases or leptomeningeal disease
  • Solid organ or allogeneic stem cell transplant recipients
  • Active hepatitis B or C infection not controlled
  • Known allergy to study drug components or severe hypersensitivity to monoclonal antibodies
  • Breastfeeding or planning to breastfeed during study
  • Major blood vessel involvement increasing bleeding risk
  • Recent live vaccine administration or planned live vaccination during study
  • History of non-infectious pneumonia requiring steroids or current interstitial lung disease
  • Significant peripheral neuropathy (grade 2 or higher)
  • Recent serious gastrointestinal conditions or surgeries within 6 months
  • Uncontrolled HIV infection
  • Active cardiovascular disease including recent thromboembolism, unstable angina, or heart failure
  • Uncontrolled illnesses such as severe infection, uncontrolled diabetes, ongoing infection, psychiatric or social conditions limiting compliance
  • Active bleeding disorders requiring anticoagulant or antiplatelet therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

Loading map...

Research Team

C

Cancer AnswerLine

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here