OncoMatch/Clinical Trials/NCT06223568
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
Is NCT06223568 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Docetaxel and Cisplatin for squamous cell carcinoma of the head and neck.
Treatment: Docetaxel · Cisplatin · PRGN-2009 — 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. ...
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV positive (high-risk HPV serotypes eligible)
History of HPV-positive status determined by a standard-of-care HPV testing. Note: All participants with high-risk HPV serotypes are eligible.
Disease stage
Required: Stage I, II
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: investigational drug
Prior therapy with an investigational drug, live vaccine, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone-directed therapy) within 4 weeks prior to the first study drug administration.
Cannot have received: live vaccine
Prior therapy with an investigational drug, live vaccine, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone-directed therapy) within 4 weeks prior to the first study drug administration.
Cannot have received: chemotherapy
Prior therapy with an investigational drug, live vaccine, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone-directed therapy) within 4 weeks prior to the first study drug administration.
Cannot have received: immunotherapy
Prior therapy with an investigational drug, live vaccine, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone-directed therapy) within 4 weeks prior to the first study drug administration.
Cannot have received: radiation therapy
Exception: except for palliative bone-directed therapy
Prior therapy with an investigational drug, live vaccine, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone-directed therapy) within 4 weeks prior to the first study drug administration.
Cannot have received: CYP3A inhibitor/inducer
Prior therapy with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A) within 2 weeks prior to the first study drug administration.
Lab requirements
Blood counts
ANC >= 1.5 x 10^9/L; Hemoglobin >= 9.0 g/dL; Platelet count >= 100 x 10^9/L
Kidney function
Creatinine <= 1.2 x ULN OR calculated creatinine clearance >=55 mL/min/1.73m^2 by Cockcroft-Gault formula
Liver function
Total bilirubin <= 1 x ULN, or <= 3 x ULN in patients with known or suspected Gilbert's Syndrome; ALT <= 1.5 x ULN; AST <= 1.5 x ULN
Individuals must have adequate organ and marrow function as defined below: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Hemoglobin (Hgb) >= 9.0 g/dL; Platelet count >= 100 x 10^9/L; Creatinine <= 1.2 x upper limit of normal (ULN) OR calculated creatinine clearance >=55 mL/min/1.73m^2 by Cockcroft-Gault formula; Total bilirubin <= 1 x ULN, or <= 3 x ULN in patients with known or suspected Gilbert's Syndrome; Alanine aminotransferase (ALT) <= 1.5 x ULN; Aspartate aminotransferase (AST) <= 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06223568 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require HPV?
Yes, HPV positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II is required.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages