Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07343596

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

Led by University of Wisconsin, Madison · Updated on 2026-04-22

20

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided written informed consent and HIPAA authorization
  • Aged 18 years or older at registration
  • ECOG Performance Status of 0-2 within 30 days before enrollment
  • Suspected clinical stage II-IVB oral cavity cancer suitable for surgery
  • Primary tumor at least 2 cm allowing a 250 mm3 research biopsy
  • No prior chemotherapy or immunotherapy for oral cavity cancer
  • Completed other cancer treatments unrelated to oral cavity cancer more than 30 days before enrollment
  • Agree to contraception during and for 100 days after study therapy if of childbearing potential
  • Females of childbearing potential must have a negative pregnancy test within 7 days before treatment
  • Demonstrate adequate organ function
Not Eligible

You will not qualify if you...

  • Diagnosed autoimmune disease requiring immunosuppressants (some controlled diseases allowed)
  • Pregnant or breastfeeding
  • Active or progressive additional invasive malignancy requiring treatment, except certain skin or in situ cancers disease-free for 3+ years
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar agents
  • Prior radiotherapy or systemic anti-cancer therapy for the head and neck cancer under study
  • Live vaccine within 30 days before first study drug dose
  • History of pneumonitis requiring steroids or current pneumonitis
  • Previous allogeneic tissue or solid organ transplant
  • Need for systemic corticosteroids (prednisone ≥10 mg daily) or other immunosuppressive drugs
  • Radiographically detectable central nervous system metastases or carcinomatous meningitis
  • Grade 3-4 bleeding due to the cancer
  • Known HIV infection or active/chronic hepatitis B or C infections
  • Psychiatric or substance abuse disorders interfering with study cooperation
  • Unable to provide independent, legal, informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Wisconsin - Madison

Madison, Wisconsin, United States, 53705

Actively Recruiting

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Research Team

A

Adam Burr, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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