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Study of Pembrolizumab for Oral Cavity Cancer

This study is looking at how people with oral cavity cancer respond to a treatment called pembrolizumab (an immunotherapy). Researchers want to see if they can create a special patient-specific tumor system, called a culture vessel, in a timely way. This culture vessel would help predict how you might respond to pembrolizumab before surgery. You would receive pembrolizumab through an IV injection before your surgery and have a research biopsy. The study aims to find changes in your genes and immune system within two months to see if the culture vessel can help identify promising markers of response. This study is currently enrolling about 20 participants who are 18 years or older.

Study design
This is an interventional study with a planned enrollment of 20 participants. The study is investigating pembrolizumab and a patient-specific culture vessel.
What's involved
You would undergo a research biopsy and receive pembrolizumab before surgery. The study measures changes in gene expression and immune environment for up to 2 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, which measure changes in gene expression and the immune microenvironment, are assessed for up to 2 months.

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NCT07343596

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

Recruiting
NAAges 18+InterventionalBasic science
University of Wisconsin, Madison
~20 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:PembrolizumabPatient-Specific Culture Vessel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in Gene Expression
Measured over up to 2 months
+2 more outcomes measured

Conditions

Oral Cavity Cancer

Explore related trials

Malignant Oral Neoplasm

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Adam Burr, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Adam Burr, MD, PhD
[email protected]
608-915-0100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Age 18 years and older at the time of registration consent
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 30 days prior to enrollment
Suspected clinical American Joint Committee on Cancer (AJCC) 8th edition stage II-IVB (T2-T4b N0-N3) oral cavity cancer (oral tongue, floor of mouth, buccal, gingival, retromolar trigone, lip, hard palate) amenable to surgical resection. Patients will be consented prior to research biopsy.
Primary tumor of at least 2 cm which is amenable to a 250 mm3 (e.g.10 mm x 5 mm x 5 mm) research biopsy, equivalent to one-two forceps biopsies.
Patients may not have received prior chemotherapy or immunotherapy for the oral cavity malignancy. Patients must have completed other cancer therapies unrelated to their oral cavity cancer greater than 30 days prior to enrollment.
Participants of childbearing potential must agree to contraception during and for 100 days after study therapy.
Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for \> 12 consecutive months.
Demonstrate adequate organ function

Exclusion

Subjects with a diagnosed auto-immune disease (exceptions: subjects with controlled diabetes mellitus type I, thyroid disease, rheumatoid arthritis, vitiligo and alopecia areata not requiring treatment with immunosuppressants are eligible)
Pregnant or breastfeeding
Known additional invasive malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease free for at least three years prior to enrollment. This excludes the index oral cavity cancer.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor.
Has received prior radiotherapy treatment or systemic anti-cancer therapy including investigational agents for the HNC under study prior to randomization/allocation.
Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has had previous allogeneic tissue/solid organ transplant.
Subjects who require systemic treatment doses of corticosteroids (prednisone equivalent greater than or equal to 10 mg daily), or other immunosuppressive drugs
Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator and radiology review
Has Grade 3-4 bleeding due to the underlying malignancy
Subjects with known human immunodeficiency virus (HIV) infection, active or chronic hepatitis B or hepatitis C infection based on medical history. No testing for HIV, Hepatitis B, or Hepatitis C is required for enrollment. Subjects cannot be positive for HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-hepatitis B core antibody. Patients with Hepatitis B surface antigen negative and anti-hepatis B core antibody positive with undetectable HBV DNA by polymerase chain reaction may enroll.
Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.
Subjects who cannot provide independent, legal, informed consent

What this trial measures

  • Changes in Gene Expressionup to 2 months

    Identification of pathways that are activated in samples showing substantial response versus those that do not. Gene expression changes will be evaluated through mRNA sequencing and bioinformatic analysis.

  • Phenotypic Changes in the Immune Microenvironmentup to 2 months

    Pathways critical for immune response will be assessed using microscopy and a custom analysis pipeline to assess changes in immune cell localization, staining and morphology that will be compared to a control condition and reported as increased or decreased compared to control. Secreted factors will be assessed in culture media using multiplex bead-based ELISA and quantification of secreted factors will be reported as a concentration (pg/ml or ng/ml) and compared to determine increase or decrease compared to control condition.

  • Genotypic Changes in the Immune Microenvironmentup to 2 months

    Genotypic changes will be assessed using bulk or single cell sequencing approaches. Differential gene expression between control and treatment conditions will be reported and compared between conditions. Gene enrichment pathway analysis will also be completed and compared between control and treatment conditions. For single cell sequencing analysis identified cell clusters will be compared between treatment conditions.