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

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07343596
Status
Recruiting
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Conditions

  • Oral Cavity Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Apr 15, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Standard of Care: Pembrolizumab
    Participants receive pembrolizumab by a needle (IV) in the arm once per standard of care (SOC)

Primary Outcome Measure

Changes in Gene Expression [ Time Frame: up to 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin - MadisonMadisonWisconsin53705
Adam Burr, MD, PhD
[email protected]
608-915-0100

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By research site
University of Wisconsin - Madison· Madison, WI

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