Experimental vaccine plus chemo aims to shrink HPV throat tumors and reduce radiation
NCT ID NCT05108870
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests two experimental vaccines (HB-201 and HB-202) given with standard chemotherapy drugs (carboplatin and paclitaxel) to people with HPV16-positive oropharyngeal cancer. The goal is to see if this combination can shrink tumors enough to allow less intensive follow-up treatment, such as robotic surgery or lower doses of radiation and chemo. About 35 participants will be followed for two years to assess safety and tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HB-201 and HB-202 (TheraT® vectors) plus carboplatin and paclitaxel chemotherapy
- What this could lead to
- If successful, this approach could shrink tumors more effectively and allow some patients to avoid high-dose radiation or extensive surgery, reducing long-term side effects.
- What could go wrong
- This is an early-phase trial with only 35 participants, so results may not apply broadly. The experimental vaccines are not yet FDA-approved, and side effects from combining them with chemotherapy are still being studied.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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35 people
The number who actually took part.
- Started
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Aug 2022
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Chicago
Chicago, Illinois, 60637, United States
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Other studies related to the condition(s) this trial covers.
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