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Advanced Head and Neck Squamous Cell CarcinomaPhase 2SENIOR-HNNCT07094685

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

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Advanced Head and Neck Squamous Cell Carcinoma and Resectable Head and Neck Squamous Cell Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
18 Nov 2025to 1 Nov 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age
  • PD-L1 combined positive score (CPS) >= 1
  • Histologically documented advanced stage mucosal HNSCC (stage II-IV), for which surgery would be recommended in routine clinical practice
  • Primary tumor is amenable to fresh biopsy or availability of archival fresh frozen primary tissue
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Absolute neutrophil count > 1500 cells/uL
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  • Platelet count >= 100,000/uL
  • Hemoglobin >= 9.0 g/dL (without transfusion within 14 days prior to cycle 1, day 1)
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) or =< 3 x ULN for participants with Gilbert's disease
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN
  • Creatinine =< 1.5 x institutional ULN OR estimated glomerular filtration rate (eGFR) value >= 30/mL using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation OR measured (OR calculated) creatinine clearance >= 50 mL/min using the Cockcroft-Gault Formula
  • Urine protein < 2+ or 24-hour urine protein quantification < 1.0 g
  • Prothrombin time (PT) or international normalized ratio (INR) =< 1.5 x ULN, and partial thromboplastin time (PTT) or activated (a)PTT =< 1.5 x ULN (unless abnormalities are unrelated to coagulopathy) This applies only to patients who are not on therapeutic anti-coagulation
  • For patients receiving therapeutic anti-coagulation there are no coagulation parameters for eligibility. However, patients should be on a stable dose
  • Female patients of childbearing age per institutional definition must have negative serum pregnancy test results before enrollment
  • Female patients of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of ivonescimab
  • Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab
  • Ability to understand and the willingness to sign a written informed consent
  • Deemed to be a candidate for trial therapy by University of Michigan providers in both Medical Oncology and Otolaryngology or Oral and Maxillofacial Surgery

Who cannot join

  • Prior radiation therapy for treatment of the current mucosal HNSCC (patients undergoing salvage resection are excluded)
  • Prior neck dissection on the side of current mucosal HNSCC
  • Major surgical procedures or serious trauma within 4 weeks prior to enrollment. Minor local procedures (excluding central venous catheterization, port implantation, and tumor biopsy) within 3 days prior to planned cycle 1, day 1
  • History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment
  • Nasal bleeding / epistaxis (bloody nasal discharge is allowed) graded as >= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 within 14 days prior to registration
  • Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not allowed. The use of full-dose anticoagulants is permitted as long as INR or aPTT is within therapeutic limits
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  • Patients with a condition requiring corticosteroid therapy (> 10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug. Exceptions: Physiologic replacement doses are allowed even if they are > 10 mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder
  • Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date. Exceptions: Patients with vitiligo, type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that has resolved, or psoriasis that does not require systemic treatment are permitted
  • Patients with symptomatic central nervous system (CNS) metastases, CNS metastases with hemorrhagic features, CNS metastasis >= 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
  • Recipient of a solid organ or allogeneic stem cell transplant
  • Patients with active hepatitis B (Patients with stable or declining levels of hepatitis B deoxyribonucleic acid [DNA] by polymerase chain reaction [PCR] on appropriate anti-viral therapy with acceptable tolerability for one month prior to enrollment will not be excluded)
  • Patients with active hepatitis C (hepatitis C virus [HCV] antibody positive with HCV ribonucleic acid [RNA] levels above the lower limit of detection)
  • Known allergy or hypersensitivity to any component of the study drug or any excipients (histidine, histidine hydrochloride, sucrose, polysorbate 80 (II), and water for injection); known history of severe hypersensitivity to other monoclonal antibodies
  • Patient is breastfeeding or plans to breastfeed during study participation
  • Radiographic evidence of major blood vessel encasement with narrowing of the vessel that the investigator determines will pose a significantly increased risk of bleeding
  • Live vaccine or live attenuated vaccine received within 4 weeks prior to planned enrollment or scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted
  • History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
  • Has pre-existing peripheral neuropathy that is >= grade 2 by CTCAE version 5
  • History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before enrollment
  • Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment
  • History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment
  • Known history of human immunodeficiency virus (HIV) whose viral load is not controlled
  • Participant has active cardiovascular disease including, but not limited to:
  • Thromboembolism
  • Medical history of any grade arterial thromboembolic event, grade 3 and above venous thromboembolic event (as specified in NCI CTCAE 5.0)
  • Cardiovascular disease
  • Any of the following within 12 months prior to enrollment:
  • Myocardial infarction
  • Unstable angina
  • Unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease)
  • Transient ischemic attack
  • Cerebrovascular accident
  • Hypertensive Crisis
  • Hypertensive encephalopathy
  • Coronary stent placement
  • Clinically non-significant thrombosis, such as non-obstructive catheter-associated thrombus, incidental or asymptomatic pulmonary embolism, are not exclusionary
  • Hypertension
  • Uncontrolled (persistent) hypertension:
  • Systolic blood pressure > 160 mmHg; diastolic blood pressure > 100 mmHg
  • Heart failure
  • Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF within 12 months prior
  • Participant has uncontrolled illness including, but not limited to:
  • Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment (excluding antiviral therapy for hepatitis B or C)
  • Uncontrolled diabetes
  • Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy)
  • Psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements
  • Active bleeding diathesis requiring anticoagulant or antiplatelet therapy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cancer AnswerLine contact

1-800-865-1125

CancerAnswerLine@med.umich.edu

United States1 site, 1 recruiting

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

    Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu

    Paul L. Swiecicki

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Study Evaluating Neoadjuvant Ivonescimab for Resectable Head and Neck Cancer

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).

Being tested
Biopsy Procedure, Biospecimen Collection, Computed Tomography, Ivonescimab, Magnetic Resonance Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET-CT and CT scan

  • IvonescimabBiological

    Also called AK 112, AK-112, AK112, Anti-PD-1/Anti-VEGF Bispecific Antibody AK112

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET-CT scan

  • Surgical ProcedureProcedure or surgery

    Also called Operation, Surgery, Surgery Type, Surgery, NOS

    Undergo surgical dissection

Study groups in NCT07094685
Study groupRoleWhat they receive
Treatment (ivonescimab)ExperimentalPatients 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.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Ivonescimab; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Surgical Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major pathologic response rate

    The major pathologic response (MPR) rate is defined as the proportion of patients achieving major pathologic response out of all response-evaluable patients. This proportion will be estimated as the number of patients with MPR divided by the total number of patients response-evaluable for pathologic response. This estimate will be presented along with a Wilson score 95% confidence interval.

    Measured: Up to 36 months

Secondary outcomes (3)

  1. Neoadjuvant ivonescimab related toxicities

    Toxicities per Common Terminology Criteria for Adverse Events version 5.0 will be summarized by number and percentage of participants with adverse events in different categories (e.g., causal relationship, grade, etc.). All safety data will be listed individually by participant and appropriately summarized.

    Measured: Up to 36 months

  2. Overall response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1

    Assessed per RECIST v1.1. The estimate will be presented along with a Wilson score 95% confidence interval.

    Measured: Up to 36 months

  3. Pathologic complete response rate

    The estimate will be presented along with a Wilson score 95% confidence interval.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start18 Nov 2025
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07094685
Sponsor's protocol ID
UMCC 2025.012
Other IDs
NCI-2025-04973, HUM00273377
Acronym
SENIOR-HN
Status last verified
Jun 2026
First submitted
23 Jul 2025
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Advanced Head and Neck Squamous Cell Carcinoma and Resectable Head and Neck Squamous Cell Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathologic response rate (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07094685.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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