Pembrolizumab for Mouth Cancer

Overseen By Adam Burr, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must be taking: Pembrolizumab

Must not be taking: Corticosteroids, Immunosuppressants, Anti-PD-1

Disqualifiers: Auto-immune disease, Pregnancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Adam Burr, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

Adults over 18 with stage II-IVB oral cavity cancer, who haven't had chemo or immunotherapy for it. They must be able to undergo a biopsy, have an ECOG status of 0-2, and agree to contraception if of childbearing potential. Those with prior unrelated cancer treatments must be 30+ days post-treatment.

Inclusion Criteria

I can care for myself and am up and about more than 50% of my waking hours.

I haven't had chemo or immunotherapy for oral cancer but finished other cancer treatments over a month ago.

I agree to use birth control during and for 100 days after the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Immunotherapy

Participants receive pembrolizumab as part of the standard of care prior to surgery

8 weeks

Pembrolizumab administered once per standard of care

Biomarker Analysis

Biomarkers are studied using single cell RNA sequencing and a patient-specific culture vessel

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab

Trial Overview

The trial is testing the creation of a patient-specific tumor culture vessel to predict treatment response and administering pembrolizumab before surgery. The study aims to see if this approach can help tailor individual care.

How Is the Trial Designed?

Group I: Standard of Care: Pembrolizumab Experimental Treatment 2 Interventions

Participants receive pembrolizumab by a needle (IV) in the arm once per standard of care (SOC)

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+