Actively Recruiting
A Phase II Study Evaluating Neoadjuvant Ivonescimab for Resectable Head and Neck Cancer
Led by University of Michigan Rogel Cancer Center · Updated on 2025-11-25
28
Participants Needed
1
Research Sites
169 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
Researchers are evaluating ivonescimab, a bispecific monoclonal antibody, in a Phase II trial for patients with stage II-IV head and neck cancer that can be surgically removed. Ivonescimab is being studied for its potential to interfere with tumor cell growth and spread by targeting molecules that trigger immune responses. The trial is sponsored by the University of Michigan Rogel Cancer Center and focuses on advanced mucosal head and neck squamous cell carcinoma. Participants receive ivonescimab through an intravenous infusion lasting 60 to 120 minutes on the first day of each 21-day cycle. Treatment may continue for up to three cycles if there is no disease progression or unacceptable side effects. Four to eight weeks after the last dose of ivonescimab, patients undergo standard surgical dissection to remove the tumor. Additional procedures include PET-CT, CT, or MRI scans and collection of blood samples throughout the trial, with biopsies performed at screening. During the study, participants undergo various imaging tests and biopsies to assess treatment response and safety. Researchers monitor outcomes such as the major pathologic response rate, overall response rate based on RECIST criteria, and pathologic complete response rate over up to 36 months. Safety assessments include tracking toxicities related to neoadjuvant ivonescimab. Total participation involves treatment cycles followed by surgery and long-term follow-up for up to three years.
CONDITIONS
Brief Title
Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- PD-L1 combined positive score (CPS) of 1 or higher
- Diagnosed with stage II-IV mucosal head and neck squamous cell carcinoma recommended for surgery
- Primary tumor suitable for fresh biopsy or archival tissue available
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count above 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 within 1.5 times the upper limit of normal or up to 3 times if Gilbert's disease is present
- AST and ALT no greater than 2.5 times the institutional upper limit
- Creatinine within 1.5 times the upper limit, or eGFR at least 30 mL/min, or creatinine clearance at least 50 mL/min
- Urine protein less than 2+ or 24-hour urine protein under 1.0 g
- Coagulation parameters within acceptable limits or stable anticoagulation if applicable
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception for both females and males as detailed
- Able and willing to provide informed consent
- Considered suitable for trial therapy by medical and surgical oncology specialists
You will not qualify if you...
- Prior radiation therapy for current head and neck cancer or prior neck dissection
- Major surgery or serious trauma within 4 weeks before enrollment
- History of bleeding disorders or significant bleeding risk
- Recent moderate or severe nasal bleeding
- Unstable use of anticoagulants or antiplatelet agents
- Need for corticosteroid therapy above 10 mg prednisone daily within 14 days before treatment
- Active or recent autoimmune disease requiring systemic therapy except specified exceptions
- Symptomatic or large central nervous system metastases
- Organ transplant recipients
- Active hepatitis B or C infection not controlled
- Known allergy to ivonescimab components or similar antibodies
- Pregnant or breastfeeding women
- Major blood vessel narrowing posing bleeding risk
- Recent live vaccinations
- History of severe lung disease or pneumonia needing steroids
- Significant peripheral neuropathy
- Recent gastrointestinal complications or bleeding
- Uncontrolled cardiovascular diseases including recent heart attack or stroke
- Uncontrolled hypertension or heart failure
- Active infections or uncontrolled illnesses
- Psychiatric or social conditions limiting study compliance
- Active bleeding conditions requiring anticoagulant or antiplatelet therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 weeks
Participants receive ivonescimab IV on day 1 of each cycle, with cycles repeating every 21 days for up to 3 cycles if no disease progression or unacceptable toxicity occurs. Blood samples, CT or MRI scans may be collected during this period.
3 infusion visits every 3 weeks and additional visits for imaging and blood sample collection
Duration - 4 to 8 weeks after treatment ends
Participants undergo standard of care surgical dissection 4 to 8 weeks after the last dose of ivonescimab.
1 surgical procedure visit
Trial Site Locations
Total: 1 location
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Cancer AnswerLine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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