Actively Recruiting
Response-Adaptive Treatment in Untreated Locoregional HPV-Negative Head and Neck Cancer
Led by University of Chicago · Updated on 2026-03-04
38
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the objective response rate following neoadjuvant therapy with volrustomig, paclitaxel, and carboplatin in previously untreated human papillomavirus (HPV)-negative locally advanced head and neck squamous cell carcinoma .
CONDITIONS
Official Title
Response-Adaptive Treatment in Untreated Locoregional HPV-Negative Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathologically confirmed locally advanced, non-metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses
- HPV must be ruled out by immunohistochemistry for oropharyngeal carcinoma; other sites must be HPV negative if tested
- For nasopharyngeal cancer, both EBV and HPV must be ruled out by immunohistochemistry
- Ability to give signed informed consent and comply with study requirements
- Willingness and ability to comply with treatment, visits, and examinations including follow-up
- Stage IV disease except nasopharyngeal primary T3N2 (stage III) per AJCC 8th edition
- Measurable disease by RECIST 1.1 criteria with at least one lesion measurable by specified methods
- No prior radiation, chemotherapy, or immunotherapy for head and neck cancer
- Age 18 years or older
- ECOG performance status of 0 or 1
- Adequate organ and marrow function as specified (leukocytes, neutrophils, platelets, hemoglobin, bilirubin, liver enzymes, LVEF, troponin, QTcF, creatinine or eGFR)
- Prior or concurrent malignancy not interfering with safety or efficacy assessment allowed
- Cardiac function class 2B or better by New York Heart Association Functional Classification
- No complete surgical resection within 8 weeks before enrollment, except biopsy or excision with residual measurable disease
- Use of adequate contraception for men and women of childbearing potential during and after study participation
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Distant metastatic disease (M1)
- Unidentifiable primary tumor site
- Prior surgical therapy other than biopsy or organ-sparing procedures with residual measurable tumor required
- Receiving other investigational agents
- Active second malignancy except certain exceptions (non-melanoma skin cancer, disease-free >3 years, or cancers unlikely to affect life expectancy)
- History of allergic reactions to study agents or similar compounds
- Uncontrolled intercurrent illness
- Pregnancy or breastfeeding; unwillingness to use effective contraception
- Intercurrent medical illnesses impairing therapy tolerance or survival (active infection, immunodeficiency, certain cardiac or pulmonary conditions, psychiatric/social issues)
- Specific cardiac conditions including cardiomyopathy, heart failure class III-IV, uncontrolled hypertension, unstable angina, significant artery stenosis, recent acute coronary events, ventricular arrhythmias requiring treatment, certain conduction abnormalities, history of QT prolongation, congenital long QT syndrome, planned cardiac surgeries or interventions
- Active infections including tuberculosis, uncontrolled HIV, active or uncontrolled hepatitis B or C, active hepatitis A
- Diagnosis of immunodeficiency or systemic steroid therapy exceeding physiologic dose within 14 days prior to treatment
- Active or prior autoimmune or inflammatory disorders with some exceptions (vitiligo, alopecia, stable hypothyroidism, chronic skin conditions not requiring systemic therapy, controlled celiac disease)
- History of allogenic organ transplantation
- Known active non-infectious pneumonitis
- Receipt of live attenuated vaccine within 30 days prior to first dose
- Blood donors who will donate blood during study and 3 months after last dose of volrustomig
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Clinical Trials Intake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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