Study to Identify Biomarkers of Oral Cavity Cancer Response to Neoadjuvant Immunotherapy Prior to Definitive Surgery
NCT07343596 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-22
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
Conditions
- Oral Cavity Cancer
Interventions
- BIOLOGICAL
-
IV injection of pembrolizumab
- DEVICE
-
Patient-Specific Culture Vessel
LumeNEXT platform, which employs a 3D matrix and allows molding of blood and lymphatic vessels
Sponsors & Collaborators
-
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Adam Burr, MD, PhD · University of Wisconsin, Madison
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-15
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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