RecruitingNot ApplicableNCT07343596

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


Sponsor

University of Wisconsin, Madison

Enrollment

20 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at what happens in the body when people with mouth cancer (oral cavity cancer) receive an immunotherapy drug before surgery. Researchers want to find biological markers that predict who responds well to this treatment. **You may be eligible if...** - You are 18 or older and have been diagnosed with stage II–IVB oral cavity cancer (tongue, floor of mouth, cheek, gum, lip, or hard palate) - Your tumor is at least 2 cm and can be surgically removed - You have not yet received chemotherapy or immunotherapy for this cancer - You are in generally good health (able to do basic daily activities) **You may NOT be eligible if...** - You have an autoimmune disease requiring immune-suppressing medications (some exceptions apply) - You are pregnant or breastfeeding - You have another active cancer being treated (some exceptions apply) - You have previously received immunotherapy (PD-1/PD-L1 drugs) - You have had a live vaccine in the last 30 days - You have had a history of lung inflammation requiring steroids, or had an organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

University of Wisconsin - Madison

Madison, Wisconsin, United States

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NCT07343596


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