Actively Recruiting
Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-04-28
70
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Throat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation. But radiation can cause serious adverse effects. Researchers believe that adding a vaccine (PRGN-2009) to this drug therapy may improve survival without the need for radiation. Objective: To test a study vaccine combined with standard chemotherapy in patients with HPV-associated throat cancers. Eligibility: People aged 18 years and older with newly diagnosed throat cancer associated with HPV. Design: Participants will be screened. They will have a physical exam and blood tests. They will have imaging scans and tests of their heart function and hearing. They will provide a sample of tissue from their tumor. A recent sample may be used; if none is available, a new sample will be taken. All participants will get two common drugs for treating cancer. These drugs are given through a tube attached to a needle inserted into a vein in the arm. Participants will receive these drugs on the first day of three 3-week cycles. Half of the participants will also get the vaccine. PRGN-2009 is injected under the skin in the arm. They will get these shots 4 times: 7 days before the start of the first cycle and on the 11th day of each cycle. Participants will have standard surgery to remove their tumors 3 to 6 weeks after completing the study treatment. They will have follow-up visits 3, 6, 12, and 24 months after their surgery. ...
CONDITIONS
Official Title
Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed surgically resectable newly diagnosed stage I (cT1-2, N0-1) or II (T1-3, N0-2), M0 oropharyngeal squamous cell carcinoma
- HPV-positive status by standard testing
- Age 18 years or older
- ECOG performance status 0, 1, or 2
- Current smokers must have less than 10 pack years; former smokers eligible if quit over 10 years ago or smoked less than 10 pack years and quit less than 10 years ago
- Planned and agreed to cancer removal surgery per standard of care
- Adequate organ and marrow function: ANC ≥ 1.5 x 10^9/L; Hemoglobin ≥ 9.0 g/dL; Platelet count ≥ 100 x 10^9/L; Creatinine ≤ 1.2 x upper limit normal or clearance ≥ 55 mL/min/1.73m2
- Total bilirubin ≤ 1 x upper limit normal or ≤ 3 x upper limit normal if Gilbert's Syndrome
- ALT and AST ≤ 1.5 x upper limit normal
- HIV-positive individuals on effective therapy with undetectable viral load, CD4 count ≥ 200, and no recent opportunistic infections
- Hepatitis B or C with undetectable viral load
- Individuals of child-bearing potential must use highly effective contraception during treatment and specified periods after
- Breastfeeding individuals willing to stop breastfeeding from treatment start through 2 months after last dose
- Tumor site amenable to biopsy and willing to undergo pre-treatment biopsy
- Willing to undergo pre-treatment PET/CT imaging
- Ability and willingness to sign informed consent
You will not qualify if you...
- Peripheral motor or sensory neuropathy greater than grade 2
- Prior investigational drug, live vaccine, chemotherapy, immunotherapy, or radiotherapy within 4 weeks before study drug
- Use of moderate or strong CYP3A inducers or inhibitors within 2 weeks before study drug
- Allergic reactions to similar drugs
- Systemic glucocorticoid or immunosuppressor use within 1 week before treatment, except low-dose corticosteroids
- Active second malignancy within 2 years except certain indolent or cured cancers
- Prior allogenic tissue or solid organ transplant
- History of heart failure
- Positive pregnancy test in females of childbearing potential
- Uncontrolled illness or unstable medical condition increasing risk for participant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
M
Melissa L Wheatley
CONTACT
C
Clint T Allen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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