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

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

Trial Details

NCT ID
NCT06223568
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Docetaxel
  • Cisplatin
  • PRGN-2009
Locations (sample)
  • Bethesda, Maryland, United States|38.98067,-77.10026

Key Eligibility Criteria

  • Histologically or cytologically confirmed surgically resectable newly diagnosed stage I (cT1-2, N0-1) or II (T1-3, N0-2), M0 oropharyngeal squamous…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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