Is NCT07094685 recruiting in Ann Arbor, MI?

Yes, NCT07094685 is currently recruiting participants at its Ann Arbor, MI location. This advanced head and neck squamous cell carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Ann Arbor clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Head and Neck Squamous Cell Carcinoma Clinical Trial in Ann Arbor, MI

Q: How do I join the advanced head and neck squamous cell carcinoma clinical trial in Ann Arbor?

To join this clinical trial in Ann Arbor, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Advanced Head and Neck Squamous Cell Carcinoma Study in Ann Arbor

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).

Sponsor: University of Michigan Rogel Cancer Center

Who Can Participate

Inclusion Criteria

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

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

Exclusion Criteria

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Ann Arbor?

Yes, this clinical trial (NCT07094685) has an active research site in Ann Arbor, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Head and Neck Squamous Cell Carcinoma Treatment Options in Ann Arbor, MI

If you're searching for advanced head and neck squamous cell carcinoma treatment options in Ann Arbor, MI, this clinical trial (NCT07094685) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Ann Arbor research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced advanced head and neck squamous cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced head and neck squamous cell carcinoma clinical trials near you to find additional studies recruiting in your area.

Advanced Head and Neck Squamous Cell Carcinoma Clinical Trial in Ann Arbor, MI

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