University of Wisconsin, Madison
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
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…
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…
IV injection of pembrolizumab
LumeNEXT platform, which employs a 3D matrix and allows molding of blood and lymphatic vessels
Arctuva estimate
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