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
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.
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. Pregnancy testing is not a research-required procedure. Any pregnancy testing will be performed as part of standard clinical care, as determined by the treating team.
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.
Single group
Pembrolizumab
Biological/VaccineIV injection of pembrolizumab
Patient-Specific Culture Vessel
DeviceLumeNEXT platform, which employs a 3D matrix and allows molding of blood and lymphatic vessels
Changes in Gene Expression
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 Microenvironment
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 Microenvironment
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.
Tumor response
Tumor response in the pathologic specimen is assessed by the area of treatment effect. This is defined as the area of tumor necrosis with associated keratinaceous debris. It will be reported as the ratio of the area of tumor effect divided by the total area of tumor.
Feasibility of implementation of a patient-specific culture vessel
Feasibility is defined as availability of patient-specific culture vessel data.
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