NCT07343596

Study to Identify Biomarkers of Oral Cavity Cancer Response to Neoadjuvant Immunotherapy Prior to Definitive Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 patient-specific culture vessel. These models will not be used to make clinical decisions in this study. Rather, to explore whether a patient-specific culture vessel readout may be feasible to incorporate within a clinical trial workflow. If this proves feasible within an 8-week timeframe, and promising biomarkers of response are identified, this culture vessel may be worthy to study further in subsequent clinical trials. The investigators chose 2 months as a time point because it is quicker than physicians can currently determine patient overall response (typically 4-6 months) to immunotherapy and still long enough to allow the model to be developed and tested appropriately. Primary objective: To identify biomarkers predicting treatment response to neoadjuvant immunotherapy in oral cavity cancer Secondary objectives: * To correlate tumor response to immunotherapy in the patient-specific culture vessel to clinical tumor response to immunotherapy in vivo (the patient) after treatment with pembrolizumab immunotherapy. * To determine the feasibility of utilizing the patient-specific culture vessel within a clinical trial workflow.

Conditions

• Oral Cavity Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV injection of pembrolizumab
DEVICE	Patient-Specific Culture Vessel	LumeNEXT platform, which employs a 3D matrix and allows molding of blood and lymphatic vessels

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-01-15
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study