Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
INCLUSION CRITERIA
1. Subjects must have clinically confirmed human papilloma virus (HPV)16-positive head
and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of
other subsites are uncommon but also eligible.
2. Must have HPV16 subtype demonstrated based on clinical guidelines established by the
study doctor.
3. Availability of ≥10 unstained 5 micron slides (to be provided to Human Tissue Resource
Center at the University of Chicago). Participants 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 of age.
5. Subjects with American Joint Committee on Cancer (8th edition, 2018) N1 (solitary
lymph node >=3cm), N2-N3 nodal disease or T3-T4 primary tumor (with any N).
6. Measurable disease (either primary site and/or nodal disease) by Response Evaluation
Criteria in Solid Tumors 1.1.
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 Cooperative Oncology Group performance status 0-1
10. Normal Organ Function as confirmed by clinical lab values.
11. Must be considered to be a candidate to receive cisplatin by the treating physician.
12. Must sign a study-specific informed consent form prior to study entry. Patients should
have the ability to understand and the willingness to sign a written informed consent
document.
13. Women of childbearing potential must have a negative serum or urine pregnancy test
(minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the
start of study drug.
14. Women must not be breastfeeding.
15. Women of childbearing potential must agree to follow instructions for method(s) of
contraception for the duration of treatment.
16. 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).
EXCLUSION CRITERIA
1. Unequivocal demonstration of distant metastatic disease (M1 disease).
2. Non-HPV16 subtype.
3. Unidentifiable primary site.
4. Intercurrent medical illnesses that impairs the patient's tolerance to therapy or
limits survival. This includes but is not limited to ongoing or active infection,
immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction,
cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance. Patients with clinically stable
and/or chronically managed medical illnesses that are not symptomatic and/or are not
expected to impact treatment on protocol are still eligible (conditions to be reviewed
by the PI to confirm eligibility).
5. Active, known, or suspected, autoimmune or inflammatory disorders requiring
immunosuppressive therapy, with the exception of low-dose prednisone (<= 10mg or
equivalent). The following are exceptions to these criteria:
- Patients with vitiligo or alopecia.
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on
hormone replacement.
- Any chronic skin condition that does not require systemic treatment.
6. Treatment with any chronic immunosuppressive medication within six months prior to the
first administration of study treatment (unless agreed otherwise).
7. Participants who have had a prior anaphylactic or other severe reaction to human
immunoglobulin or antibody formulation administration.
8. Herbal remedies with immune-stimulating properties or known to potentially interfere
with major organ function within 28 days prior to the first dose of study treatment,
unless agreed otherwise with the primary investigator.
9. Prior surgical therapy other than incisional/excisional biopsy or organ-sparing
procedures such as debulking of airway-compromising tumors. Residual measurable tumor
is required for enrollment as discussed above.
10. Participants receiving other investigational agents.
11. Prior systemic anti-cancer treatment within the last 8 weeks.
12. Has a known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the
skin that has undergone potentially curative therapy or in situ cervical cancer or any
tumors that are not likely to influence life expectancy in the subsequent 3 years
without active treatment.
13. Has known history of, or any evidence of active, non-infectious pneumonitis.
14. Has known active Hepatitis B or hepatitis C. If eradicated, patient is eligible.
15. Has received a live vaccine within 28 days of planned start of study therapy.