Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer

Inclusion Criteria

• •1. Subjects must have clinically confirmed Human papillomavirus(HPV)-positive head and neck squamous cell cancer of the back of the mouth/throat (oropharynx). Confirmed HPV-positive disease of other subsites are uncommon but also eligible.
• •2. HPV testing must be compliant with the following criteria:
• •1. P16INK4a immunohistochemistry (p16 IHC) positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al72).
• •2. p16 IHC positivity is to be validated using an HPV Polymerase chain reaction (PCR - a type of DNA copying method).
• •3. HPV PCR must demonstrate HPV16 or HPV18 subtype
• •3. Availability of greater than 10 unstained 5 micron slides (to be provided to HTRC at the University of Chicago). Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.
• •4. Participants must be at least 18 years old.
• •5. Participants with American Joint Committee on Cancer (AJCC) (8th edition, 2018) N1 (\>=3cm), N2-N3 nodal disease or T3-T4 primary tumor.
• •6. Measurable disease (either primary site or nodal disease) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
• •7. No previous radiation or chemotherapy for a head and neck cancer.
• •8. No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual measurable disease is acceptable.) No surgical procedures or biopsies will occur after baseline scans are performed and measurable lesions are identified.
• •9. Eastern Cooperate Oncology Group performance status 0-1
• •10. Normal organ function clinically confirmed by medical records.
• •11. Participants must sign a study-specific informed consent form prior to study entry. Participants should have the ability to understand and the willingness to sign a written informed consent document.
• •12. Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug.
• •13. Women must not be breastfeeding.
• •14. Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment.
• •15. Men who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).