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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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 (NCT06223568) is a Phase 2 interventional studying Squamous Cell Carcinoma of the Head and Neck and Oropharynx, sponsored by National Cancer Institute (NCI). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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. ...

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Squamous Cell Carcinoma of the Head and Neck and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 70 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Squamous Cell Carcinoma of the Head and Neck subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

* Who May Qualify: - diagnosed by tissue sample (biopsy-confirmed) surgically resectable newly diagnosed stage I (cT1-2, N0-1) or II (T1-3, N0-2), M0 oropharyngeal squamous cell carcinoma. Note: Pathological report of cancer diagnosis may be from the primary tumor or from a metastatic cervical lymph node. - History of HPV-positive status determined by a standard-of-care HPV testing. Note: All participants with high-risk HPV serotypes are eligible. - Age \>= 18 years. - ECOG performance status \<= 2. - Individuals who smoke currently must smoke \<10 pack years. Note: Former smokers with any pack-year history are eligible if quit smoking \>10 years before study treatment initiation. Former smokers who quit \<10 years before study treatment initiation must have smoked \<10 pack years. - Planned for cancer removal surgery per standard of care (SOC) and individual had agreed for the cancer removal surgery. - 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 - Individuals serologically positive for human weakened immune system virus (HIV) must: - be on effective anti-retroviral therapy for at least 4 weeks; and - have undetectable viral load; and - have the CD4 count \>=200 cells/microL; and - have no reported opportunistic infections or Castleman s disease within 12 months prior to study treatment initiation - Individuals serologically positive for Hepatitis C virus (HCV) or Hepatitis B virus (HCB) must have an undetectable viral load. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
* INCLUSION CRITERIA: * 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. Note: Pathological report of cancer diagnosis may be from the primary tumor or from a metastatic cervical lymph node. * History of HPV-positive status determined by a standard-of-care HPV testing. Note: All participants with high-risk HPV serotypes are eligible. * Age \>= 18 years. * ECOG performance status \<= 2. * Individuals who smoke currently must smoke \<10 pack years. Note: Former smokers with any pack-year history are eligible if quit smoking \>10 years before study treatment initiation. Former smokers who quit \<10 years before study treatment initiation must have smoked \<10 pack years. * Planned for cancer removal surgery per standard of care (SOC) and individual had agreed for the cancer removal surgery. * 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 * Individuals serologically positive for human immunodeficiency virus (HIV) must: * be on effective anti-retroviral therapy for at least 4 weeks; and * have undetectable viral load; and * have the CD4 count \>=200 cells/microL; and * have no reported opportunistic infections or Castleman s disease within 12 months prior to study treatment initiation * Individuals serologically positive for Hepatitis C virus (HCV) or Hepatitis B virus (HCB) must have an undetectable viral load. * Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of the study treatment and up to 2 months after the last dose of PRGN-2009 and an effective method of contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for 14 months after the last dose of cisplatin/docetaxel. Note: IOCBP is defined as any woman who has experienced menarche and has not had a hysterectomy or bilateral oophorectomy or is not postmenopausal (amenorrheic 12 months or more following cessation of exogenous hormonal treatments; if \<50 years old and need follicle stimulating hormone \[FSH\] in the post-menopausal range). Men must agree to use a highly effective method of contraception (surgical sterilization, abstinence) for the duration of the study treatment and up to 2 months after the last dose of PRGN-2009 and an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 11 months after the last dose of the study drug(s). We also will recommend men on treatment with PRGN-2009 with female partners of childbearing potential ask female partners to be on highly effective birth control (hormonal, intrauterine device (IUD), surgical sterilization) during PRGN-2009 treatment and 2 months after that. * Breastfeeding individuals must be willing to discontinue breastfeeding from study treatment initiation through 2 months after the last dose of the study drug(s). * Individuals must have a tumor site that is amenable to biopsy and be willing to undergo pre- treatment biopsy for research purposes. * Individuals must be willing to undergo pre-treatment PET/CT imaging study. * The ability of an individual to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Peripheral motor or sensory neuropathy \> Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v.5 at screening. * 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. Note: Participants may continue adjuvant hormonal therapy in the setting of a definitively treated cancer (e.g., breast). * Prior therapy with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A) https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm#table2-2,table3-3,table5-2 within 2 weeks prior to the first study drug administration. * History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study. * Systemic (intravenous or oral) glucocorticoid (except for physiologic doses of corticosteroids, i.e., \<= the equivalent of prednisone 10 mg/day) or other immunosuppressors such as azathioprine or cyclosporin A within 1 week prior to study treatment initiation. Note: Glucocorticoids as premedication for contrast-enhanced studies are allowed. * Second malignancy active within the previous 2 years except for indolent or locally curable malignancy that is currently considered cured and/or does not require an additional standard of care treatment, such as, but not limited to, cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer or differentiated thyroid cancer. * Prior allogenic tissue/solid organ transplant. * History of heart failure. * Positive beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening. * Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history and physical exam or situations that are not stable (e.g., recent hospitalization, Emergency Room visit or undergoing medication changes) that would potentially increase risk for the participant.

Treatments Being Tested

DRUG

Docetaxel

Docetaxel 75 mg/m\^2 will be administered over 60 (+/-10) minutes.

DRUG

Cisplatin

Cisplatin 75 mg/m\^2 will be administered over 120 (+/-10) minutes.

DRUG

PRGN-2009

PRGN-2009 will be administered in Arm 2 participants only as an SQ injection in the arm at a dose of 1 mL nominally containing 5x10\^11 viral particles (VP) on Day -7 (+/-3 days) of Cycle 1, Day 11 (+/-3 days) of Cycles 1, 2, and 3.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Institutes of Health Clinical Center
Bethesda, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06223568), the sponsor (National Cancer Institute (NCI)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06223568 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06223568?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06223568?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT06223568. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06223568. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.