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 (May 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
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)
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
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