Title
Study to identify biomarkers of oral cavity cancer response to neoadjuvant immunotherapy prior to definitive surgery

Description
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.

Objective
Primary objective: To identify biomarkers predicting treatment response to neoadjuvant immunotherapy in oral cavity cancer

Secondary objectives:

-To correlate tumor response to immunotherapy in the patient-specific culture vessel to clinical tumor response to immunotherapy in vivo (the patient) after treatment with pembrolizumab immunotherapy.
-To determine the feasibility of utilizing the patient-specific culture vessel within a clinical trial workflow.

Treatment In this trial, the team will investigate biomarkers using single cell RNA sequencing and a patient-specific culture vessel. These models will not be used to make clinical decisions in this study. Rather, to explore whether a patient-specific culture vessel readout may be feasible to incorporate within a clinical trial workflow. If this proves feasible within an 8-week timeframe, and promising biomarkers of response are identified, this culture vessel may be worthy to study further in subsequent clinical trials.

The investigators chose 2 months as a time point because it is quicker than physicians can currently determine patient overall response (typically 4-6 months) to immunotherapy and still long enough to allow the model to be developed and tested appropriately.

Key Eligibility Inclusion Criteria:

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

Applicable Disease Sites
Head and Neck

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital