Study to Identify Biomarkers of Oral Cavity Cancer Response to Neoadjuvant Immunotherapy Prior to Definitive Surgery
University of Wisconsin, Madison
Summary
The goal of this clinical trial is to study whether researchers can create a patient-specific tumor system, called a culture vessel, in a timely manner and determine if it can predict how someone will respond to a specific therapy. Participants will: * Undergo a research biopsy * Take pembrolizumab per standard of care prior to surgery
Description
Immunotherapy has improved survival for selected patients with recurrent/metastatic head and neck cancer. The Keynote-689 study results published in the New Eng J Med demonstrating improved event free survival for head and neck cancer patients receiving pembrolizumab prior to surgery prompted the June 12, 2025 FDA approval of pembrolizumab as a standard of care option. However, selecting those patients most likely to benefit from this approach is challenging due to a lack of predictive biomarkers. In this trial, the team will investigate biomarkers using single cell RNA sequencing and a patie…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately * Age 18 years and older at the time of registration consent * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 30 days prior to enrollment * Suspected clinical American Joint Committee on Cancer (AJCC) 8th edition stage II-IVB (T2-T4b N0-N3) oral cavity cancer (oral tongue, floor of mouth, buccal, gingival, retromolar trigone, lip, hard palate) amenable to surgical…
Interventions
- BiologicalPembrolizumab
IV injection of pembrolizumab
- DevicePatient-Specific Culture Vessel
LumeNEXT platform, which employs a 3D matrix and allows molding of blood and lymphatic vessels
Location
- University of Wisconsin - MadisonMadison, Wisconsin